F D A U P D AT E & P R O D U C T N E W S
GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2013
On May 3, Ethicon Endo-Surgery, Inc., announced the FDA premarket approval of the Sedasys System, the first computer-assisted, personalized sedation (CAPS) system. Sedasys is indicated for the IV administration of 1% (10 mg/mL) propofol (Diprivan, AstraZeneca) injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as defined by the American Society of Anesthesiologists (ASA) Continuum of Depth of Sedation guidelines, in ASA physical status 1 and 2 patients aged 18 years or older who are undergoing colonoscopy and esophagogastroduodenoscopy procedures. “The Sedasys System will address the growing preference for propofol sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases,” said principal investigator Daniel
Pambianco, MD, medical director, Charlottesville Medical Research, Charlottesville, Va., and paid consultant for Sedasys. “The technology will empower health care facilities to more effectively use their limited resources to deliver greater value in the increasingly resource-constrained U.S. health care environment.” Data included in the premarket application demonstrated that patients who received sedation with the Sedasys System experienced fewer and less significant oxygen desaturation events than patients in a control group who received traditional sedation with benzodiazepines and opioids. The data also showed patients who received sedation with the Sedasys System recovered from the effects of sedation faster, with 99% recovering within 10 minutes, compared with those in the control group. The company reported that patients were highly satisfied with sedation provided by the Sedasys
US Endoscopy Launches AquaShield Water Bottle System With CO2 Extension Tubing
Photo courtesy of US Endoscopy
In April, US Endoscopy announced the release of the AquaShield water bottle system with CO2 extension tubing. The new product is used in conjunction with an air or carbon dioxide (CO2) source to clean the lens of the endoscope during a procedure. “The AquaShield system with CO2 extension tubing offers a convenient solution to our customers
The AquaShield system has extended tubing that eliminates the need for extra pieces during procedures where CO2 is used.
using CO2 insufflation,” said Gulam Khan, president of US Endoscopy, in a statement. “This new line item eliminates the need for purchasing and setup of separate CO2 extension tubing, saving our customers time and money.” In procedures where CO2 is used, extension tubing is required to connect the water bottle cap to an insufflator or CO2 source. According to a statement by US Endoscopy, most water bottle systems on the market today require customers to stock and use two separate items: the water bottle cap and CO2 tubing. The new AquaShield system with extended tubing eliminates the need for these extra pieces. The disposable AquaShield water bottle system is a 24-hour use system that eliminates the need to reprocess or deal with lost or replacement components. It also proactively supports patient safety by reducing the risk for bacterial contamination that may remain in reusable systems, US Endoscopy said. —Based on a press release from US Endoscopy
System, and physicians were significantly more satisfied with administration of sedation they provided to patients in the Sedasys group compared with sedation provided to patients in the control group. The Sedasys System will be marketed by Sedasys, a division of Ethicon Endo-Surgery, Inc., which will offer the system to facilities where an anesthesia professional is immediately available for consultation or assistance. In addition to receiving device-specific training, the member of the physician-led team who is administering sedation must have training in the
management of cardiorespiratory effects of propofol. “Anesthesiologists and gastroenterologists were key participants in the development of the Sedasys System, and we believe the technology has the potential to improve the experiences of both the clinical team and the patient,” Dr. Pambianco said in a company press release. The Sedasys System is scheduled to launch on a limited basis beginning in 2014. Sedasys plans to conduct two postapproval studies to monitor the use of the technology in actual clinical practice. —Based on a press release from Ethicon Endo-Surgery, Inc.
Lubiprostone Approved for OpioidInduced Constipation The FDA has approved a supplemental new drug application for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 mcg twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic noncancer pain (CNCP). Lubiprostone also is approved in the United States for the treatment of chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women. Binding of opioids to peripheral opioid receptors in the gastrointestinal (GI) tract results in absorption of electrolytes, such as chloride, and subsequent reduction in small intestinal fluid. Additionally, activation of enteric opioid receptors results in abnormal GI motility. Together, these processes result in OIC, which is characterized by infrequent and incomplete evacuation of stool, hard stool consistency and straining associated with bowel movements. Approximately 40% to 80% of patients taking opioids for CNCP report constipation. Some patients may discontinue opioid therapy and thereby endure pain rather than suffer from the constipation caused by opioids. Lubiprostone is a specific activator of ClC-2 chloride channels in the intestinal epithelium, thereby bypassing the antisecretory action of opiates. The approval of lubiprostone is based on results from Phase III studies of 12 weeks’ duration in patients taking opioids (among them, morphine, oxycodone and fentanyl) for CNCP, as well as a long-term, open-label safety study, which provided additional support for use in this population. Two of the Phase III studies met their overall efficacy end point, whereas a third Phase III study did not. The effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. In clinical trials of lubiprostone versus placebo, the most common adverse reactions were nausea and diarrhea. Full prescribing information for Amitiza can be found at www.amitiza.com. —Based on a press release from Sucampo and Takeda
Photo courtesy of Takeda Pharmaceuticals
Sedasys System Approved for Administration of Sedation In Upper GI Endoscopy and Colonoscopy Procedures
Photo courtesy of Ethicon Endo-Surgery, Inc.
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