A BOS TON S C I E N TI F I C P UB L I C AT I O N
O CT /N OV 2017 • I SSU E 2
E N H A N C I N G PATI EN T O U TC OMES. DELIVER IN G TOTAL VALU E.™
Addressing Infection Prevention in the GI Lab with the Orca™ Sterile Single-use Air/Water and Suction Valves
Innovation and Customer Collaboration are Focus of New Facility in Galway, Ireland
A Message From Art Butcher As leaders in the field of GI Endoscopy devices, our Boston Scientific team understands that the role we play is about much more than just being a supplier—our customers demand considerably more than that. We aim instead to be an indispensable partner for our customers—a partner that understands the varying needs of physicians and administrators in tertiary care centers, community hospitals, and surgery centers as well. We aspire to be the partner that addresses important industry issues, establishes new service offerings to help manage costs, and offers highly specialized expertise to improve patient care. We are driven by “Advancing Science for Life” and that statement reflects our entire orientation as an organization.
One of the important issues we are focused on today is infection
Getting an accurate and timely diagnosis for patients is another
prevention in Endoscopy. Managing the spread of infectious
objective that is paramount for our endoscopy customers. Today,
disease has been a longstanding challenge in healthcare. In recent
of the top diagnostic pathology labs in the United States, Boston
years, the awareness and concern around risks associated with
Scientific’s lab is currently the only facility focused solely on GI
infection transmission during endoscopic procedures has grown
disease.* Our dedicated clinical staff, GI trained lab technicians,
substantially. As hospitals have worked to address this issue, there
and customer service teams are focused on improving the
has been a shift from the idea of controlling transmission to a
diagnosis process for physicians and their patients. In this issue,
stated goal of infection prevention. In support of this, Boston
we hear from Dr. Booker Dalton and our own Pathology Medical
Scientific is delivering effective solutions for endoscope reprocessing
Director Dr. Jeremy Miller on the importance of getting an accurate
and safe scope transport. We are also presently launching our new
diagnosis for sessile serrated adenomas and why GI Specialized
Orca Sterile Single-use Air/Water and Suction Valves to
Pathology matters in delivering better outcomes for patients.
help prevent disease transmission by eliminating the difficult tasks of cleaning and tracking today’s intricate reusable valves.
The combination of these new services and solutions, in addition to our comprehensive portfolio of devices, empowers us to make
Another important challenge we are addressing is the need for
a positive difference in healthcare delivery. From devices that offer
high quality and affordable endoscope maintenance. Reliable scope
utility for the everyday treatment of GI disease to innovative
performance is critical to the daily operations of the endoscopy
systems that treat the most complex of pancreatico-biliary cases,
suite. Yet for many of our customers, scope repair has become
we are continually developing innovative treatment options and
costly and difficult to manage. Through a strategic partnership
seeking new ways to meet the evolving needs of our customers.
with Total Scope, Inc., we now offer an alternative scope
Together as indispensable partners, we will navigate the ever-
repair service with attractive pricing and a proven track record
changing healthcare landscape while making a transformative
of providing great customer service and high quality. Total Scope’s
difference in patients’ lives.
facilities have been certified to the quality standard ISO 13485, which is specific to the service, repair, and maintenance of endoscopes and other medical instrumentation—these are the same guidelines followed by the original scope manufacturers.
Art Butcher Senior Vice President, Boston Scientific President, Endoscopy Division
*As of August 2017. Based on data from the U.S. Anatomic Pathology Market Forecast & Trends 2017-2020
In This Issue
2 3 4 5 17 Back Cover
Infection Prevention in the Endoscopy Suite: Organizational Culture, Process Standardization and Devices Have a Role to Play
Boston Scientific Adds Scope Repair to its Services and Solutions Offering
Creating a Customized e-Preceptor Experience
Boston Scientific Celebrates Launch of a New Facility in Galway
National Pancreas Foundation Honors Boston Scientific with Vision of Hope Award Resolution 360 ™ Clip Recognized for Design and Engineering Excellence
News and New Devices
u Boston Scientific is a proud sponsor of three walks in support of pancreatic cancer research. • New England Pancreatic Research Walk, Saturday, October 7 • Long Island Pancreatic Research Walk, Sunday, October 8 • Denver Pancreatic Research Walk, Sunday, November 5 u Sign up for news, product updates and more at www.bostonscientific.com/ endo-access-subscribe u Follow us on Twitter @BSC_Endoscopy
Physician Case Studies GI Specialized Pathology..................................................................................................... 6 AXIOS™ Stent and Electrocautery Enhanced Delivery System .................................. 7, 10 Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device..................... 8, 9, 11 SpyGlass™ DS Direct Visualization System.................................................................12-16
Images on the cover owned by Boston Scientific.
Infection Prevention in the Endoscopy Suite: Organizational Culture, Process Standardization and Devices Have a Role to Play Infection prevention has become an increasingly important issue for healthcare providers and is the subject of countless articles in journals and magazines. Growing reports of cross-contamination events and patient risk have put increased focus on endoscope reprocessing and cleaning protocols, with a particular emphasis on the need to effectively perform the manual cleaning steps. Endoscopes are difficult to clean and, if not done properly, the disinfection procedures can fail, increasing the potential for transmitting infection from one patient to another.
LTHOUGH REPROCESSING GUIDELINES HAVE BEEN CREATED, these guidelines are left to interpretation by hospitals and their staff, and may be challenging to perform with consistency. “Despite best efforts, current reprocessing procedures are performed correctly only 1.4% of the time1. Results such as these are due to a failure in the overall system, and not simply the individuals performing the actual reprocessing,” explains Grace Thornhill, Ph.D., infection prevention fellow at Boston Scientific.
The addition of cleaning and tracking endoscope accessories adds yet another layer of complexity to an already intricate process. For example, there are over 30 individual steps to manually clean the air/water and suction valve sets. The guidelines also require that accessories be kept with the scope throughout reprocessing, creating additional tracking steps as part of the process.2
There are many aspects to managing infection in healthcare settings and there is no single solution to address Orca™ Sterile Single-use Air/Water all areas. “An overall culture of Suction Valves. quality and safety must be initiated, supported and sustained from top levels of the organization to convey the importance of this issue and to foster change,” said Thornhill. In order to help support infection prevention in the endoscopy suite and improvements within the endoscope manual cleaning process, Boston Scientific has developed the Orca™ Sterile Single-use Air/ Water and Suction Valves. The Orca single-use valves are a new product designed to minimize the risk of infection transmission via air/water and suction valves and to improve efficiencies by eliminating the need for cleaning and tracking. The Orca valves
provide single-use benefits with the same feel and performance as reusable valves. The Orca Valves can be
ordered individually or as part of the Compliance EndoKit™, a comprehensive endoscope reprocessing kit designed to promote process standardization and consistency from start to finish.
To learn more visit www.bostonscientific.com.
› Learn about the Orca Compliance EndoKit™
Valves and other infection prevention products.
References: 1) O fstead et al. 2010. Endoscope Reprocessing Methods. A Prospective Study on the Impact of Human Factors and Automation. Gastroenterology Nursing 33:4 304-311. 2) A NSI/AAMI Flexible and semi-rigid endoscope reprocessing in health care facilities. SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes. Images owned by Boston Scientific.
› Learn more about scope repair.
Boston Scientific Adds Scope Repair to its Services and Solutions Offering Scope maintenance is critical to the day-to-day operations of the endoscopy suite and patient care. Long-term service contracts, year-over-year cost increases, lengthy repair times and poor customer service are some of the issues that make scope repair costly and difficult to manage.
Technicians take a streamlined approach to the repair process and are committed to excellence with the goal of “zero defects at the table.”
Yet, alternatives have been limited. For some, contractual commitments and vendor reliability concerns made it difficult to make a change. Now, through a strategic partnership with Total Scope, Inc., Boston Scientific offers scope repair services provided by Total Scope, Inc. that offer “on par” scope manufacturer quality processes, flexible payment programs, and a proven track record of excellent customer service. “By talking with our customers and understanding their pain points, it was clear that we could offer something significantly better,” said Meghan Scanlon, vice president of marketing, Boston Scientific Endoscopy. “We are pleased to offer this best-inclass service that gives our customers an alternative scope repair solution that addresses cost and simplifies the repair process.” FOCUSED ON QUALITY
Total Scope follows the same quality processes that are used by top scope manufacturers and adhere to the standards of the International Organization for Standardization (ISO). Total Scope’s Upper Chichester, Pennsylvania facility is ISO 13485 certified, which is specific to the medical device industry for service, repair and maintenance of scopes and other medical instrumentation. Total Scope’s web portal offers 24/7 secure online access to initiate repairs, track repair status, and access account information and reports.
Services from Total Scope are available only in the U.S.
Total Scope, Inc. is a premier independent, third-party endoscope repair company since 1993 and a woman-owned business.
Images provided courtesy of Total Scope.
Creating a Customized e-Preceptor Experience As new and advanced endoscopic technologies continue to emerge, the need for physicians to keep their knowledge and skills updated is critical to positively impacting clinical outcomes and improving procedural efficiencies.
RADITIONAL PRECEPTORSHIP PROGRAMS where physicians spend a day at another facility observing live cases and interacting with experts in disease management are increasingly identified by many as having the greatest value and impact on learning. Yet access to these programs may be limited due to geographic availability, travel costs and time away from a physician’s busy practice. And for physicians who can attend, that day’s schedule may not provide the opportunity to observe the types of cases and technologies the physician is most interested in or provide enough training to improve their technical skills.
Professor Mutignani discusses a case with a remote audience.
A new virtual EDUCARE program from Boston Scientific is redefining preceptorship learning. The new e-preceptorship is designed to allow the user to
create a tailored learning experience from any location, on any device. Other features include:
Up to four views can be seen simultaneously.
• Ongoing access to watch live cases performed by physician experts • Ability to customize your training curriculum and receive notifications when live cases of interest are scheduled • Options to select your preferred view and change it at any time during the procedure • Question-and-answer sessions with physician experts after every live case • Cases made available on-demand post live procedure In collaboration with leading endoscopic experts, the e-Preceptor platform was developed to offer high quality broadcasts of live cases from a growing network of international centers of excellence. Introduced in Italy last year, live cases will now be broadcast from almost 20 centers in 2018 reaching more than 500 clinicians with plans to expand this initiative over the next couple of years across Europe, the U.S. and beyond. In addition, a new one-year e-Preceptorship program, the CPR@ Program, dedicated exclusively to ERCP training for advanced technologies such as the SpyGlass™ DS System, offers disease management lectures, procedural techniques and remote observation and discussion of live cases. This program, currently available in Italy, is led by Prof. Massimiliano Mutignani, director of digestive endoscopy and intervention at Hospital Niguarda Ca’Granda, Milano, who has performed over 22,000 procedures and co-authored more than 110 publications. Images owned by Boston Scientific.
T he new e-Preceptor program has changed the way we train physicians. It’s really a revolution in the training paradigm, said Prof. Mutignani.
“Whether a clinician wants to learn new or advanced skills or just improve their procedural techniques, the new e-Preceptor platform offers an innovative alternative to traditional programs,” said Darragh Tolan, vice president of Boston Scientific Endoscopy, Europe. “Physicians from virtually any remote location can select a customized curriculum, watch live cases presented by physician experts at times that work for their busy schedule and, most important, bring new skills and technologies to the care of their patients.”
Boston Scientific Celebrates
Launch of New Facility in Galway
INVESTMENT SUPPORTS RESEARCH, PRODUCT DEVELOPMENT AND INNOVATION
Boston Scientific celebrated the launch of its RoadRunner design facility in Galway, Ireland, on June 8, 2017. A number of international research and clinical experts attended the event, which also marked the 20-year anniversary of Boston Scientific’s European Innovation Centre in Galway. IN ADDITION TO THE DESIGN FACILITY, the RoadRunner process was created to deliver novel devices in a six-month timeframe. Using the RoadRunner process, the Boston Scientific team developed two new enteral stents, including the WallFlex™ Duodenal Soft Stent and the WallFlex Colonic Soft Stent.1 With feedback from physicians, these stents were developed to offer greater flexibility and ease of use. For example, these stents are softer when bent and on a slimmer delivery system.
The Galway site produces:
1) W allFlex Duodenal Soft Stent, WallFlex Colonic Soft Stent, and WallFlex Enteral Soft Stent are not for sale in the U.S.
(Left to right) Darragh Tolan, vice president, Boston Scientific Endoscopy, Europe, Irish Minister Sean Kyne, and Terri Kapur, director of R&D, Boston Scientific at the official opening of the RoadRunner design facility in Galway, Ireland.
New WallFlex™€ Enteral Soft Stent1
“We are excited by the early successes coming out of RoadRunner. Creating the agile RoadRunner team has allowed us to deliver rapid innovation, incorporating physician feedback to create meaningful advances for patients who need GI stents. Going forward, we are applying the RoadRunner philosophy and learnings to other parts of our business. Our investment signifies our commitment to ensuring the long-term sustainability of innovation and to investing in the technology of the future,” said Art Butcher, senior vice president, Boston Scientific and president of the Endoscopy Division.
3 million devices per YEAR 200,000 devices per MONTH 10,000 devices per DAY 400 devices per HOUR 7 devices per MINUTE For more information visit www.bostonscientific.eu.
Images owned by Boston Scientific.
Diagnosing Sessile Serrated Adenomas â€ş Visit EndoSuite to learn
more about GI Specialized Pathology.
CASE PRESENTED BY: BOOKER DALTON, JR., M.D.
JEREMY MILLER, M.D.
Gastroenterologist Digestive Healthcare of Georgia Atlanta, Georgia, USA
Pathology Medical Director Boston Scientific GI Specialized Pathology
The patient is a 63-year-old female with a clinical history of colonic polyps. Patient presented for colonoscopy for surveillance due to patient history. PROCEDURE
Colonoscopy was performed and three polyps were removed via polypectomy. The first was a flat 6mm polyp that was removed in two parts from the hepatic flexure. 10mm and 1mm polyps were identified and removed from the sigmoid colon. Initial pathological findings classified each of the three polyps as hyperplastic with no malignancy or dysplasia. Upon receiving the results, Dr. Booker Dalton remained concerned that the polyp in the hepatic flexure was misclassified as a hyperplastic lesion and could potentially be a sessile serrated adenoma (SSA) due to its location and endoscopic appearance. Dr. Dalton contacted Dr. Jeremy Miller, medical director of Boston Scientific GI Specialized Pathology, for a second opinion. Upon reviewing the slides microscopically, Dr. Miller determined that the polyp from the hepatic flexure was an SSA. The two sigmoidal lesions were both confirmed as hyperplastic.
DR. DALTON, GASTROENTEROLOGIST, DISCUSSION
DR. MILLER, PATHOLOGIST, DISCUSSION
The polyp in the hepatic flexure had the telltale characteristics of an SSA: a medium to large flat lesion with a mucus cap in the right colon. I was quite surprised when the pathology report came back as a hyperplastic polyp. At that point, I considered two primary options for managing this patient:
I agree with the course of action taken by Dr. Dalton in managing this patient and applaud his diligence. It is important for gastroenterologists and pathologists to collaborate to provide appropriate management and surveillance for their patients. It is equally important for patients to receive a report that provides an accurate diagnosis.
1. T reat in accordance with ACG guidelines where all right side hyperplastic polyps are treated as SSAs, and patients are managed on a three- or five-year surveillance interval. 2. Q uestion the diagnosis and seek a second opinion from a GI-fellowed pathologist to confirm the polyp as an SSA. Although both options would ultimately provide the same surveillance protocol for the patient, my belief is that I owe my patients a definitive and accurate diagnosis for collective peace of mind.
Pathology services not available outside of the United States.
Although SSAs do not follow the traditional adenomatous pathway, these lesions can serve as markers for potential malignancies. Given their potential, it is important for physicians to track their SSA rates similar to how they track their adenoma detection rates. Current literature suggests a 9-10% benchmark for SSA detection to ensure consistent identification, removal, and pathological diagnosis. Additionally, gastroenterologists should challenge individual hyperplastic findings for suspicious flat lesions in the right colon. A second opinion can provide peace of mind for all parties while also alleviating potential headaches from insurance payers in justifying shortened surveillance intervals.
EUS-guided Pancreatic Pseudocyst Drainage Using the AXIOS™ Stent and Electrocautery Enhanced Delivery System
CASE PRESENTED BY: CARLOS ROBLES-MEDRANDA, M.D. Instituto Ecuatoriano De Enfermedades Digestivas Guayaquil, ECUADOR
First case from Latin America PATIENT HISTORY
A 36-year-old man presented to a referring institution with acute upper abdominal pain, nausea, and vomiting. He was diagnosed with acute necrotizing pancreatitis and received clinical management in an intensive care unit. Clinical improvement was noted, but four weeks later the patient started to experience nausea and early satiety. A new abdominal CT scan was performed and showed a 9.6 x 13.5cm hypodense cystic collection in the body of the pancreas, which compressed the stomach wall. A pancreatic pseudocyst was suspected and the patient was referred to our center. Performing EUS-guided drainage using the AXIOS Stent and Electrocautery Enhanced Delivery System was proposed.
Drainage was performed under general anesthesia. Just before the procedure was performed, an intravenous antibiotic was administered using 3rd-generation cefalosporin. A 3.8mm working channel linear-array therapeutic echoendoscope attached to a US console was used, a 13.9 x 10.8cm anechoic area was localized on the pancreatic body, and the pseudocyst was discovered (Figures 1 and 2). A 15x10mm AXIOS Stent was selected due to the size of the cyst and the high volume of liquid inside it. Then, the AXIOS Stent 10.8Fr catheter was passed through the echoendoscope biopsy channel (Figure 3) and an electrosurgical unit was attached to the monopolar plug in the upper portion of the device. Under ultrasound guidance, the cyst’s wall was punctured. Soon after, the catheter entered the cyst, the stent was delivered, and the catheter was pulled against the cyst’s wall until the flange shape changed from oval to rounded. The device was locked and the stent’s external flange was delivered. This important step allows the stent’s external flange to be delivered inside the stomach, preventing deployment into the wall. The handle of the device was then unlocked and using a push-torquing maneuver, the stent’s external flange was delivered into the stomach. Finally, using a standard gastroscope, the stent was visualized and confirmed to be positioned well within the gastric wall, and a brownish liquid was drained (Figure 4). About 1,500cc of liquid were aspirated and to avoid pulmonary aspiration, an 18Fr nasogastric tube was placed.
The procedure was well tolerated by the patient and no intra- or post-procedure complications were experienced. The total procedure time was 4 minutes in this case. After two hours of observation in the recovery room, the nasogastric tube was withdrawn and the patient was discharged to an outside institution. An endoscopic withdrawal was performed 15 days after the procedure, and a complete resolution of the pseudocyst was observed.
EUS-guided drainage of pancreatic pseudocysts has been studied in recent years. Regarding EUS-guided drainage techniques, we observed during this case that the AXIOS Stent had some important advantages compared with other standard methods.
› Watch educational
programs and cases featuring the AXIOS Stent.
The AXIOS Stent and Electrocautery-Enhanced Delivery System Indications for Use: The AXIOS Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size and walled-off necrosis ≥ 6cm in size with ≥ 70% fluid content that are adherent to the gastric or bowel wall. Once placed, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. Europe: The Hot AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst, walled-off necrosis (≥70% fluid content) or the biliary tract. Images provided courtesy of Dr. Robles-Medranda.
Performing Challenging Endoscopic Ultrasound-guided Fine Needle Aspiration Procedures: Report of Two Cases
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) can be very useful to achieve a definitive diagnosis due to its high diagnostic capability, minimal invasiveness, and safety. The procedure has contributed to the definitive pathological diagnosis of pancreatic disorders, submucosal tumors in the digestive tract, and mediastinal and celiac lymph node enlargement, where non-invasive specimen collection is difficult.1 Although many reports indicate that the diagnostic rate using EUS-FNA is roughly 90%2, different types of puncture needles are being developed to further improve diagnostic capability. There are reports in past literature that the diagnostic rate falls as tumor size decreases.3,4 A larger specimen can be collected by EUS-FNA when using a longer stroke after puncture; however, it is often impossible to achieve an adequate stroke with puncture at maximum length, such as when the target is small or elliptical, making tissue sampling difficult. Thus, various techniques have been devised for EUS-FNA of small lesions.5,2 While a diagnosis could be made using cytology, more and more immunostaining and genetic analyses are being performed as a result of advancements in research and personalized medicine, requiring more reliable tissue sampling. A new tissue acquisition needle (Acquire™ Endoscopic Ultrasound Fine Needle Biopsy [FNB] Device [Boston Scientific]) was developed in order to help physicians collect more tissue. Whereas older-style puncture needles featured one cutting surface, this Franseen-type needle has three. Thus, it firmly grasps the tissue with the three tips, and can collect a specimen by suction as the tissue is cut away. In addition, it can obtain cylindrical tissue specimens with the wide, triple-3D cutting faces, and in our experience has significantly increased the percentage of correct diagnoses. We report two cases in which adequate tissue sampling was not possible with a conventional suction biopsy needle, but a definitive diagnosis was obtained with repeat EUS-FNA using the Acquire FNB Needle. CASE 1
An EUS-FNA was performed on an 18mm, echogenic, gastric subepithelial lesion. The lesion was continuous with the proper muscular layer. An EUS-FNA had been attempted twice over the previous two years, using an older-style aspiration needle. However, it wasn’t possible to collect an adequate tissue specimen for immunostaining (Figure 1a) , and a definitive diagnosis was not obtained. On a recent third attempt, an EUS-FNA procedure was performed using the Acquire™ FNB Needle. The puncture stroke length was 15.0mm, and the puncture was performed three times. Adequate specimens were collected (Figure 1b) , and c-kit/CD34-negative, Desmin-negative, S100-protein-positive (Figure 1c) immunostaining yielded a diagnosis of schwannoma.
(Continued on next page)
CASE PRESENTED BY: AKANE YAMABE, M.D.
ATSUSHI IRISAWA, M.D.
Department of Gastroenterology Aizu Medical Center, Fukushima Medical University Aizuwakamatsu, JAPAN
Department of Gastroenterology Aizu Medical Center, Fukushima Medical University Aizuwakamatsu, JAPAN
Several foci of lymphadenopathy of unknown origin were noted in the abdominal cavity. To obtain a definitive diagnosis, an EUS-FNA procedure was attempted one year prior, using an aspiration needle; however, sufficient tissue collection for histology was impossible (Figure 2a). During subsequent monitoring of the clinical course, a slight increase in the severity and growth of the lesion was noted; therefore, we decided to reattempt an EUSFNA recently, using the Acquireâ„˘ FNB Needle. The maximum dimension of the enlarged target lymph node was 10mm; puncture stroke length was only 2.2mm, and puncture was performed twice. Even under these difficult conditions, by using the Acquire FNB Needle, it was possible to collect a specimen that enabled histological evaluation (Figure 2b). No malignant findings were noted, and the diagnosis was reactive lymphadenopathy.
Our cases demonstrated the high quality of tissue for histology obtained by the Acquire FNB Needle. Acquire has shown considerable capability in cases with a small target lesion and short puncture stroke length. Since reliable specimen collection was possible in these challenging cases, we believe that the Acquire FNB Needle can serve as the first-choice needle for all of our EUS-FNA procedures. Sample size and quality were large/high in EUS-FNA using the Acquire FNB Needle in comparison with the specimen in previous EUS-FNA using a conventional aspiration needle (40x). Therefore, immunostaining (S-100) was more easily performed in the specimen obtained using the Acquire FNB Needle. Sample size was larger in EUS-FNA using the Acquire FNB Needle in comparison with the specimen in previous EUS-FNA using conventional aspiration needle (40x).
â€ş Watch educational programs and read more case studies featuring the Acquire FNB Device.
References: 1) Y amao K, Sawaki A, Mizuno N et al. Endoscopic ultrasound-guided fine-needle aspiration biopsy(EUS-FNAB): past, present, and future. J Gastroenterol 40:1013-1023,2005. 2) Yamabe A, Irisawa A, Bhutani MS et al. Efforts to improve the diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration for pancreatic tumors. Endosc Ultrasound. 2016;5:225-32. 3) Siddiqui AA, Brown LJ, Hong SK et al. Relationship of pancreatic mass size and diagnostic yield of endoscopic ultrasound-guided fine needle aspiration. Dig Dis Sci. 2011;56:3370-5. 4) A kahoshi K, Sumida Y, Matsui N et al. Preoperative diagnosis of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration. World J Gastroenterol. 2007;13:2077-82. 5) Yamabe A, Irisawa A, Bhutani MS et al. Usefulness of endoscopic ultrasound-guided fine-needle aspiration with a forward-viewing and curved linear-array echoendoscope for small gastrointestinal subepithelial lesions. Endosc Int Open. 2015;3:E161-4. Images provided courtesy of Drs. Yamabe and Irisawa.
Performing a Successful Cystogastrostomy Using the AXIOS™ Stent and Electrocautery Enhanced Delivery System
CASE PRESENTED BY: ARKADY BRODER, M.D. Director of Endoscopy Saint Peter’s University Hospital Division of Gastroenterology Advanced Therapeutic Endoscopy New Brunswick, New Jersey, USA
DEVENDRA ENJAMURI, M.D. Saint Peter’s University Hospital Division of Gastroenterology New Brunswick, New Jersey, USA
A 31-year-old male with a history of recently diagnosed acute necrotizing pancreatitis secondary to choledocholithiasis was admitted for abdominal pain. An abdominal ultrasound revealed multiple cysts with septations in the pancreatic region and multiple gallstones. The patient then underwent an MRI of his abdomen which revealed multiple pseudocysts, the largest one measuring 9.8 x 11.6 x 17cm along the body and tail of the pancreas. The other cysts measured 10.6cm extending to the left lower quadrant, and a 9cm cyst along the anterior aspect of the head of the pancreas (Figures 1 and 2). The patient underwent EUSguided cystogastrostomy with staged endoscopic necrosectomy using the AXIOS Stent and Delivery System. PROCEDURE
On initial endoscopy, extrinsic compression of the gastric body and antrum was noticed. Multiple cystic lesions and a large area of walled-off necrosis (WON) was identified in the peripancreatic region. Using a 15mm AXIOS Electrocautery Enhanced System, a cystogastrostomy was performed, and the stent was noted to be in a good position. The stent track was then dilated to 12.5mm. The cyst was notably filled with fluid and necrotic tissue with good drainage post-stent placement (Figures 3 and 4). A solution of 1:10,000 hydrogen peroxide was instilled into the cavity to enable the removal of necrosis. On repeat endoscopy with EUS, the previous cystic cavity was notably completely collapsed and the preexisting gastric stent was removed. An additional large pancreatic body pseudoscyst was References: 1) S hah RJ, Shah JN, Waxman I, et al. Safety and efficacy of endoscopic ultrasoundguided drainage of pancreatic fluid collections with lumen-apposing covered selfexpanding metal stents. Clin Gastroenterol Hepatol. 2015;13(4):747-52. See back cover for Warnings and information. Images provided courtesy of Drs. Broder and Enjamuri.
identified in the sub-hepatic region and using a 10mm AXIOS Stent, the cyst was punctured and the stent was successfully deployed (Figure 5). A total of 2 liters of yellow fluid was drained. Several weeks later, the patient underwent a repeat necrosectomy using a snare and 2:1 hydrogen peroxide. The pancreatic fluid collection extended to the pelvic region, and the remaining fluid collection eventually required CT-guided drainage with complete eventual resolution. Finally the patient underwent an ERCP, which revealed pancreatic duct stenosis with disruption and contrast leak in the genu of pancreas.
The patient is continued on IV antibiotics (linezolid and ertapenem for VRE on culture of aspirate). His symptoms, including pain, improved. A repeat CT of the abdomen showed significant resolution of the pancreatic fluid collections. He was maintained on pancreatic enzyme replacement therapy. The patient then underwent laparoscopic cholecystectomy and underwent a repeat ERCP 3 months later. A pancreatogram revealed a normal, healed duct with no extravasation.
Successful placement of the EUS-guided AXIOS Electrocautery Enhanced System helped the patient avoid surgical intervention for multiple symptomatic pseudocysts and WON. Clinical evidence associated with placement of two AXIOS stents has not been extensively evaluated.
› Watch educational programs and cases featuring the AXIOS Stent.
Diagnosing a Small Neuroendocrine Tumor Using Fine Needle Biopsy
CASE PRESENTED BY: TYLER STEVENS, M.D. Associate Professor Department of Gastroenterology and Hepatology Cleveland Clinic Cleveland, Ohio, USA
A 70-year-old-man was referred for an endoscopic ultrasound (EUS) to evaluate a tiny hyperenhancing nodule in the uncinate process of the pancreas discovered on a CT scan. The nodule was discovered on a workup of RUQ pain and diarrhea which had already resolved promptly with cessation of metformin. Other than hyperlipidemia and type 2 diabetes that the patient had under good control, he had no other relevant medical history. He does not smoke or drink alcohol heavily. The patient was very afraid he might have pancreatic cancer because his cousin recently died of the disease at age 62. PROCEDURE
Based on the CT appearance, a neuroendocrine tumor was suspected. An EUS with tissue acquisition was planned to confirm the diagnosis and obtain prognostic information. Linear EUS was performed, assisted by monitored anesthesia care. A small hypoechoic uncinate nodule was found from the second portion of the duodenum, measuring only 7mm in its greatest diameter. The Acquireâ„˘ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device was chosen to optimize yield and allow for characterization of tumor differentiation. The needle was directed into the distal aspect of the mass (Figure 1). Five back-and-forth motions were performed within the mass. The needle was removed from the scope to express the specimen into a formalin container. This process was repeated twice. Several whiteappearing tissue fragments were obtained and sent to surgical pathology for analysis. OUTCOME
The patient experienced no bleeding or pain, and was discharged one hour after the procedure. The results of histology revealed a well-differentiated neuroendocrine tumor without visible mitotic figures (Figure 2). A KI-67 stain was done to ascertain the proliferative index, and only 1% of cells stained positive, indicating a well-differentiated neuroendocrine tumor (Figure 3). The patient was evaluated by a pancreatic surgeon. Because of the small size of the lesion and well-differentiated histology, continued imaging surveillance was suggested rather than undergoing pancreaticoduodenectomy. CONCLUSION
I have found that confirming the diagnosis of small (<1cm) neuroendocrine tumors (let alone assessing differentiation) can be quite difficult with fine needle aspiration because it is hard to puncture the mass and obtain adequate cellular material. Obtaining a core biopsy can be useful in risk-stratifying neuroendocrine tumors and guiding therapy. The Acquire FNB Device performed well in this case, because it provided a very good specimen for histology and immunohistochemical staining. It was also easy to penetrate and obtain a high-quality specimen from a very small mass.
â€ş Watch educational programs and
read more case studies featuring the Acquire FNB Device.
Images provided courtesy of Dr. Stevens.
Using Cholangioscopy with Electrohydraulic Lithotripsy to Remove a Difficult Common Bile Duct Stone
CASE PRESENTED BY: RAHSAAN FRIEND, D.O. CGH Medical Center Sterling, Illinois, USA
The patient, a 78-year-old female, was admitted to the hospital through the emergency department for elevated liver function tests and dark-colored urine that had been getting increasingly darker for the past several days. The patient has a past medical history of metastatic squamous cell carcinoma to the left inguinal node, diagnosed approximately two and a half years ago, for which the primary source was not identified. She refused chemotherapy and radiation and just wanted active surveillance. The patient had no significant abdominal pain, but reported some nausea and dry heaving as well as headaches while at home. Liver function tests were elevated with a total bilirubin of 3.69 with mostly direct of 2.9, alkaline phosphatase 367, AST 182, ALT 242, and total protein 8.3. The patient’s AFP tumor marker was 1.4 and CA 19-9 was 1. PROCEDURE
On initial admission, a CT scan of the abdomen and pelvis showed interval progression of intra- and extrahepatic biliary ductal dilation with heterogenicity-enhancing soft-tissue mass in the common bile duct at the level of the porta hepatis, which was highly concerning for neoplastic process. The common bile duct was noted to be severely dilated at 2.3cm.
“EHL has enabled removal of stones in my patients with choledocholithiasis less traumatically than in the past. This is a direct result of less-invasive procedures needed to completely remove retained
or impacted biliary stones. In my experience, The patient was taken for an ERCP. The biliary tree was filled with dilute utilizing EHL through the SpyGlass DS System has contrast. This revealed multiple stones throughout the main bile duct; the resulted in improved patient outcomes when traditional largest in the middle third of the duct, measuring 2.5cm x 4cm in size (Figure 1). A medium-sized sphincterotomy was performed as well as mechanical lithotripsy was previously unsuccessful.” several balloon sweeps. The balloon sweeps removed multiple smaller — Rahsaan Friend, D.O. stones, but the larger stone could not be removed. A 3cm retrieval basket CGH Medical Center was used inside the common bile in an attempt to remove the large stone. Sterling, Illinois, U.S.A. Multiple pieces of the large stone were removed with the basket, but the entirety of the stone could not be removed. Cholangioscopy was also performed using the SpyGlass™ DS System. This revealed a large 2.5cm x 4cm stone (Figure 2). A 7Fr, 10cm plastic stent was placed in the bile duct with the outer tip in the duodenum (Figure 3). The patient was discharged from the hospital the following day as her bilirubin came down to 1.8, alkaline phosphatase to 299, AST 81, and ALT 131. She was informed she would need to come back for stent removal/exchange and for stone removal using electrohydraulic lithotripsy (EHL). (Continued on next page)
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ERCP WITH CHOLANGIOSCOPY AND EHL
The patient was brought back 3 ½ weeks later for removal of the retained stone with EHL. The previously placed plastic biliary stent was removed and sent to anatomic pathology. The lower third of the main bile duct revealed a filling defect on fluoroscopy. Cholangioscopy revealed a moderately severe stricture in the lower third of the bile duct (Figure 4). It was traversed. The biliary orifice as well as the distal duct stricture was dilated, the largest areas up to 10mm, with a biliary dilation balloon to accommodate the cholangioscopy procedure. Cholangioscopy using the SpyGlass™ DS System revealed the large, 2.5cm x 4cm stone along with the distal duct stricture. The strictured area appeared to have an increased vascularity throughout (Figure 5). Targeted biopsies were performed of this stricture using SpyBite™ Biopsy Forceps (Figures 6 and 7). Additionally, aspirates of the common bile duct were obtained and sent along with the removed stent and the tissue biopsies to anatomic pathology. The EHL probe was inserted through the SpyScope™ and successful fragmentation of the large, 2.5cm x 4cm stone was performed, in addition to fragmenting multiple smaller stones within the common bile duct. Then, multiple balloon sweeps of the duct were performed to remove the fragmented pieces of stones. A final balloon sweep through the bile duct confirmed that the duct was clear. A 10Fr, 7cm plastic stent was placed in the bile duct with the outer tip in the duodenum to ensure biliary drainage (Figure 8). OUTCOME
The anatomic pathology report was complete a few days later. The common bile duct aspirates showed minimal nuclear atypia which is interpreted as reactive due to the stent/stone and associated acute inflammation. There was no definitive evidence of malignancy. The stent that had been placed in the common bile duct for 3 ½ weeks showed rare benign-appearing ductal epithelial cells with no evidence of malignancy. The biopsies of the common bile duct stricture revealed extensive acute and chronic inflammation. There is some reactive atypia, but no definitive evidence of dysplasia or malignancy. The patient was seen as an outpatient in the GI clinic two weeks later and reported no pain. She is scheduled for a repeat ERCP in approximately three months to remove/exchange the stent and evaluate the bile duct stricture. CONCLUSION
With the use of the SpyGlass DS System, the patient was discovered to have an area of irregular and friable mucosa at the medial portion of the common bile duct. This area was biopsied using SpyBite Biopsy Forceps and the histopathological evaluation did not show any evidence of malignancy. This would not likely have been possible without the availability of SpyGlass DS System technology.
Images provided courtesy of Dr. Friend.
Cholangioscopy with Direct Visualization May Enable Accurate Diagnosis of an Early-Stage Cholangiocarcinoma
CASE PRESENTED BY: DR. SIMON HEW MBBS, FRACP (Left) DR. DAVID DEVONSHIRE (Right) Monash Medical Centre Victoria, AUSTRALIA
A 55-year-old male presented to our department with a three-week history of upper abdominal pain and jaundice. He had no constitutional symptoms. He had a past history of stroke, hypertension and dyslipidemia. On presentation, the patient was noticeably jaundiced but had no features of cholangitis. Initial biochemistry demonstrated a bilirubin of 187mmol/L (normal range is 0 to 20 mmol/L), alanine transaminase of 232mmol/L (normal range is 5 to 40mmol/L) and a gamma-glutamyltransferase of 973mmol/L (normal range is 5 to 50 mmol/L). Magnetic resonance cholangiopancreatography (MRCP) demonstrated a 7mm stricture in the common bile duct (CBD) just distal to the main duct and cystic duct (Figure 1). Endoscopic ultrasound was unable to visualize the stricture due to poor views and two endoscopic retrograde cholangiopancreatographies (ERCP) were performed demonstrating a focal stricture (Figure 2) , but with non-diagnostic brushings and biopsies. After discussion at a multidisciplinary meeting, the patient proceeded to an exploratory laparotomy, where four subcapsular liver lesions were noted, not previously seen on cross-sectional imaging. The lesions were biopsied. Histopathology interestingly demonstrated inflammatory pseudotumor, rather than a malignant process.
Given the high clinical suspicion of a malignancy, the decision was made to further investigate the biliary stricture via single-operator cholangioscopy using the SpyGlass™ DS Direct Visualization System. As a sphincterotomy had previously been cut, the CBD could be free-hand cannulated with the SpyGlass DS System. In the mid-CBD just before the cystic duct take-off, an approximate one centimeter-long stricture was encountered. The high-quality visualization provided by the SpyGlass DS System clearly showed an abrupt mucosal change, with a circumferential area of hyperemic, nodular and neovascularized mucosa (Figures 3 and 4). Using the SpyBite™ Biopsy Forceps, four targeted biopsies were obtained (Figure 5). The rest of the biliary tree was explored using the SpyGlass DS System and no other abnormalities were found.
Histopathology confirmed a poorly differentiated cholangiocarcinoma. After staging imaging, the patient proceeded to a pylorus-preserving pancreaticoduodenectomy. His tumor was staged as a Stage IB tumor and he is awaiting adjuvant chemotherapy. DISCUSSION
This case illustrates the utility of the SpyGlass DS System. After unsuccessful attempts to yield a tissue diagnosis via EUS, ERCP and surgery, the SpyGlass DS System helped facilitate an accurate diagnosis of a suspicious biliary stricture. Its superior optics compared to the first-generation system allows for the visualization of subtle but present mucosal changes of the bile duct in many cases. Intra-ductal biopsies can be targeted with greater confidence. Just as a high-definition colonoscopy has improved adenoma detection rates, the SpyGlass DS System may improve the detection of early cholangiocarcinomas. 5
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the role of cholangioscopy in main duct cholangiocarcinoma.
Images provided courtesy of Drs. Hew and Devonshire.
Using Cholangioscopy to Investigate Anatomical Variation and Facilitate Stone Extraction through Selective Cannulation
CASE PRESENTED BY: DHAVAN PARIKH, M.D. The Everett Clinic Everett, Washington, USA
A 76-year-old man was referred by an outside hospital and presented to our hospital with biliary colic. Computed tomography imaging at outside facility noted choledocholithiasis and cholelithiasis. Upon admission, the patient was noted to have elevated bilirubin (7.8 mg/dL) and alkaline phosphatase (346 U/L) levels. An initial ERCP with sphincterotomy was performed with clearance of the common bile duct. The patient underwent laparoscopic cholecystectomy the following day with intraoperative cholangiogram showing multiple filling defects in the common bile duct, presumably from dropped stones during the cholecystectomy. PROCEDURE
Cannulation of the papilla was performed through the existing sphincterotomy and a 0.035” x 450cm straight Hydra Jagwire™ High Performance Guidewire was placed into the biliary tree. A cholangiogram showed multiple filling defects in the mid common bile duct (Figure 1). Sphincteroplasty up to 10mm was performed, followed by balloon sweeps that recovered numerous cholesterol stones. An occlusion cholangiogram was then performed to assess for clearance of the bile duct. This showed two filling defects adjacent to the distal common bile duct (Figure 2). A balloon sweep was then repeated but failed to clear the filling defects. The SpyGlass™ DS System SpyScope™ was passed over the existing guidewire to investigate further. Cholangioscopy was performed and uncovered atypical biliary anatomy with low medial insertion of the cystic duct (Figure 3). The guidewire was removed and the SpyScope was advanced into the cystic duct where two yellow stones were
detected (Figure 4). The SpyScope was then used to selectively cannulate the cystic duct, which was confirmed on fluoroscopy (Figure 5). The SpyScope was then exchanged for an extraction balloon and balloon sweeps of the cystic duct led to removal of both stones (Figure 6). Repeat occlusion cholangiogram through the main duct did not reveal any additional filling defects (Figure 7). The patient tolerated the procedure well and showed both symptomatic and chemical/laboratory improvement during long-term follow-up. OUTCOME
The patient had retained stones within the cystic duct that were unable to be removed by standard balloon sweep. The SpyGlass DS System was used to identify a rare cystic duct variant and enabled selective cannulation. Ultimately, this enabled clearance of retained stones within the cystic duct. CONCLUSION
The patient had retained stones within a cystic duct of unusual anatomy and low medial insertion that could not be retrieved by standard cannulation and balloon sweep. The SpyGlass DS System allowed for detection of anatomical variation in the biliary tract and selective cannulation of the cystic duct, which would have otherwise been a significant technical challenge, possibly requiring repeated procedures and surgical intervention. The SpyGlass DS System is a useful tool for delineation of biliary tract anatomy and facilitates selective cannulation, reducing procedure time and allowing for endoscopic management of disease.
educational programs and videos on cholagioscopy.
Images provided courtesy of Dr. Parikh.
Diagnosing Cholangiocarcinoma Using Cholangioscopy with Targeted Biopsies
CASE PRESENTED BY: ESTEPHAN ZAYAT, M.D. (Left) FREDY NEHME, M.D. (Right) Wesley Medical Center Wichita, Kansas, USA
An 81-year-old female presented for acute onset fever, abdominal pain and jaundice secondary to acute cholangitis. Urgent ERCP with cholangiogram showed a dilated common bile duct (CBD) with a filling defect in the upper third of the main bile duct. An 8.5Fr x 7cm plastic stent was successfully placed with purulent drainage noted. Sphincterotomy was not attempted due to recent use of anticoagulation. Patient initially improved then developed acute cholecystitis (Figure 1) requiring percutaneous cholecystostomy. She experienced progressive clinical improvement and was later discharged. A follow-up ERCP was scheduled two weeks later. PROCEDURE
An ERCP was performed and the plastic stent was initially removed from the CBD using a snare. Deep cannulation of the CBD was performed over a guidewire using a sphincterotome. The cholangiogram showed a 20mm stricture in the proximal CBD with upstream dilation (Figure 2). A 5mm biliary sphincterotomy was performed. At this point, the SpyGlass™ DS Direct Visualization System SpyScope™ was used to directly examine the CBD stricture. Direct visualization revealed significant narrowing with friability and loss of vascular pattern of the stricture (Figures 3 and 4). SpyBite™ Biopsy Forceps were introduced and a direct biopsy of the stricture was performed. Also, fluid was sent for cytology. Then, one 10Fr x 7cm plastic stent was placed 6cm into the CBD. Normal bile flow was visualized through the stent. OUTCOME
The patient tolerated the procedure and did not experience any complications. Her liver chemistries progressively normalized. Fluid cytology was non-diagnostic. Biopsies of the common bile duct stricture taken under direct visualization with SpyBite Biopsy Forceps were positive for moderately differentiated invasive adenocarcinoma (Figures 5 and 6) , consistent with cholangiocarcinoma. DISCUSSION
This case demonstrates the utility of the SpyGlass DS System in evaluating equivocal fluoroscopy findings during ERCP. The SpyGlass DS System allowed for clear visualization and biopsy of a distal CBD stricture. Despite nondiagnostic cytology, the SpyGlass DS System provided excellent resolution in combination with a conclusive histological diagnosis to guide oncologic treatment.
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Images provided courtesy of Drs. Zayat and Nehme.
Image Reference Guide to view various types of benign and malignant conditions using the SpyGlass DS System.
National Pancreas Foundation Honors Boston Scientific with Vision of Hope Award BOSTON SCIENTIFIC WAS AWARDED THE VISION OF HOPE BY THE NATIONAL PANCREAS FOUNDATION at their Party For A Cure 20th anniversary gala and fundraising event, held October 19 in Boston, Massachusetts. “The National Pancreas Foundation is proud to honor Boston Scientific with the Vision of Hope Award for their work in developing cutting-edge therapeutic and diagnostic devices and their commitment to philanthropy,” said Matt Alsante, executive director of the National Pancreas Foundation. Endoscopy President, Art Butcher accepted the award on behalf of Boston Scientific. The Vision of Hope Award is presented to a person or organization whose achievements provide increased hope for better patient outcomes. Awardees receiving this honor have contributed in a significant way to the advancement of care, treatment, and hope for patients suffering from pancreatic disease. The Party For A Cure honors those who have battled pancreas disease, as well as those who have dedicated their lives and careers to the treatment of pancreas disease patients. The event raises money to fund innovative
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Boston Scientific supports pancreatic cancer awareness through its sales donation program.
research that will lead to the development of new and better therapies for pancreas diseases.
Resolution 360 ™ Clip
Recognized for Design and Engineering Excellence
IT IS THE FIRST AND ONLY HEMOSTASIS CLIP TO HAVE RECEIVED RECOGNITION OF THIS KIND FROM THE MEDICAL DESIGN EXCELLENCE AWARDS® (MDEA). The MDEA is the premier awards program for the medical technology industry. Since its inception in 1998, the mission of the MDEA has been to recognize significant
achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. The Resolution 360 Clip received 2017
a bronze award in the gastrointestinal and genitourinary devices category.
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Resolution 360 Clip.
Images owned by Boston Scientific. Word mark used with permission from the MDEA.
News and New Devices ›
T he Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (EUS-FNB) 19ga Flexible Device is the latest addition to the Boston Scientific EUS portfolio. The new device features a flexible Nitinol needle construction for flexibility, passability and actuation. It also features a Franseen needle tip, which is an improved three-point cutting design for sample acquisition.1,2,3 The Acquire EUS-FNB 19ga Flexible Needle is a good option for liver biopsy cases, which require needle flexibility for navigation and acquisition in challenging lobe anatomy.
1) D ahnert, Wolfgang F, et al (1992) Fine-Needle Aspiration Biopsy of Abdominal Lesions: Diagnostic Yield for Different Needle Tip Configurations. Interventional Radiology, 185:263-268. 2) Data on file with no statistical difference from Cook ProCore needle. 3) B allard, Gary L. and Boyd, Wayne R. (1978) A Specially Designed Cutting Aspiration Needle for Lung Biopsy. American Journal of Roentgenology, 130: 899-903.
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T he Orca™ Sterile Single-Use Air/Water and Suction Valve is a new product designed to minimize the risk of infection transmission and to improve efficiencies by eliminating the need for cleaning and tracking. The Orca valves offer single-use benefits with the same feel and performance as re-usable valves.
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For product information visit www.bostonscientific.com/gastro or www.bostonscientific.eu For services and solutions visit www.bostonscientific.com/endoscopysolutions For educational videos visit www.endosuite.com
The paper used for this publication has been produced in accordance with:
The AXIOS Stent and Electrocautery-Enhanced Delivery System Indications for Use: The AXIOS Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size and walled-off necrosis ≥ 6cm in size with ≥ 70% fluid content that are adherent to the gastric or bowel wall. Once placed, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. Europe: The Hot AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst, walled-off necrosis (≥70% fluid content) or the biliary tract. IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand. Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary. Results from case studies are not predictive of results in other cases. Results in other cases may vary. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. All trademarks are the property of their respective owners. All rights reserved. © 2017 Boston Scientific Corporation or its affiliates. All rights reserved. DINEND2382EA.
ENDO-499920-AA October 2017
Published on Nov 9, 2017