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VTNREPORT ANGIODYNAMICS ANGIOGRAPHIC PRODUCTS TAKES UP SLACK FROM COOK MEDICAL RECALL Taking advantage of the market vacuum created by the Cook Medical recall of its angiographic products, Angiodynamics has added a second production line at its Queensbury, N.Y., production facility. AngioDynamics hired 75 workers this summer and brought back a retired supervisor to help make angiographic catheters used in medical imaging procedures. The manufacturing line making angiographic products had been operating on a single shift but has added more workers for a second shift. “We’ve beefed up our second shift … because those lines were just idle on the second shift so that’s where we put our labor, and we’ve been running into overtime so we can get those other 20 to 25 folks in and trained,” Jeremy Sharp, director of the company’s New York operations, told the Albany Business Review. Previously, the company had been consolidating manufacturing operations at its Glens Falls location and turning the Queensbury site into a distribution center. All except the angiographic line have been moved. Senior Vice President of Global Operations Barbara Kucharczyk said the consolidation plans were put on hold because of the increased demand following Cook Medical’s recall.
DESALVO RESIGNS AS ONC NATIONAL COORDINATOR; DEPUTY TAKES OVER Dr. Vindell Washington, formerly principal deputy national coordinator in the Office of the National Coordinator for Health Information Technology, has been nominated to replace Dr. Karen DeSalvo, who resigned. Washington will be the first African-American to hold the top job at ONC, an office created in 2004. Washington has been DeSalvo’s deputy since January. Like DeSalvo, he came from Louisiana; Washington previously was president of Franciscan Missionaries of Our Lady Health System Medical Group in Baton Rouge, as well as CMIO of the health system. DeSalvo’s departure from ONC has been expected for a long time. She was named acting assistant secretary in October 2014, specifically to help address the Ebola outbreak that was raging at the time. In May 2015, President Obama formally nominated DeSalvo for the assistant secretary position. She had a confirmation hearing from a Senate committee in August 2015, but her nomination never got to the floor of the Senate in gridlocked Washington.
COVALON WINS SAUDI CONTRACT TO SUPPLY IV CLEAR ANTIMICROBIAL SILICONE VASCULAR ACCESS DRESSING Covalon Technologies Ltd, an advanced medical technologies company, has won another major contract to supply its IV Clear antimicrobial silicone vascular access dressing to Ministry of Health facilities in Saudi Arabia at a minimum guaranteed value of $3.5 million over 12 months. IV Clear will be used on adults and children to help protect them from infections arising as a result of intravenous catheters, such as IV catheters, central venous lines, peripherally inserted central catheters, hemodialysis catheters, other intravascular catheter and percutaneous devices. IV Clear is the only antimicrobial clear silicone vascular access dressing that combines silver and chlorhexidine to provide broad-spectrum antimicrobial activity for 7 days. The soft silicone adhesive provides greater patient comfort, does not macerate or damage the skin, and was shown to be up to 10 times less painful upon removal when compared to acrylic adhesives. In addition to IV Clear, Covalon markets a full line of advanced wound management dressings for both acute and chronic wounds under its ColActive Plus and CovaWound brands. As well, Covalon is also the only provider of a dual antimicrobial silicone adhesive surgical dressing called SurgiClear, which is designed to protect surgical incisions by helping to prevent infections and medical adhesive skin injuries, while providing total incision site visibility to the healthcare provider.
INCLOSURE VCD GETS CE MARK OK FOR CLOSING LARGE BORE ARTERIAL PUNCTURES InSeal Medical has received CE mark approval for its large bore vascular closure device, InClosure VCD, which will close large bore arterial punctures ranging from 12F to 21F. Large bore delivery systems are used in different catheter based procedures such as transcatheter aortic valve replacement (TAVR) and percutaneous endovascular treatment of abdominal aortic aneurysms (PEVAR).
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The InClosure VCD, which is implanted percutaneously, requires no pre-procedure or sheath exchange. It is based on a biodegradable membrane paired to vessel wall by a thin nitinol frame. The flexible membrane is said to exploit blood pressure to enhance sealing, providing reliable hemostasis even in calcified arteries. InClosure clinical study principal investigator Ran Kornowski, MD, said: “The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR. While TAVR and EVAR systems have progressed, the procedures are still limited by suboptimal vascular closure technologies. We’re very excited to help change this as the InClosure VCD becomes available in Europe.”
ANGIODYNAMICS HIRES EXEC VP AND CFO Michael Greiner, 43, was appointed executive vice president and chief financial officer of AngioDynamics Inc. effective Aug. 16. A day after Greiner was hired, the company and Mark Stephens agreed that Stephens would leave the company. Prior to his appointment as executive vice president and chief financial officer, Greiner most recently was chief financial officer of Extreme Reach Inc. Prior to this position, he served as senior vice president of corporate finance and chief accounting officer for Vistaprint N.V., where he had global responsibility across treasury, tax, financial systems, controllership and SEC reporting, internal audit and corporate real estate Greiner is a certified public accountant and earned his B.S. and M.S. degrees in accounting at Fairleigh Dickenson University, as well as an MBA at Columbia University Business School.
MEDTRONIC HIRES BUSINESS VP Medtronic has hired Mark Ploof as its new senior vice president of global operations and business services effective Oct. 31. He will serve on the company’s executive committee and will lead its global operations; information technology, facilities; and real estate and business services functions, which also include its ongoing efforts to integrate the businesses it acquired in its purchase of Covidien in 2015. Ploof joins Medtronic from marketing firm YP, where he served as chief customer experience officer. He will replace Gary Ellis, who is retiring after 27 years with the company.
PURSUIT VASCULAR RAISES $2.1 MILLION Maple Grove, Minn.-based Pursuit Vascular, which produces the ClearGuard HD end caps for hemodialysis catheters that are designed to kill bacteria inside long-term hemodialysis catheters, has raised $2.1 million in a new round of debt financing. The caps are designed with a chlorhexidine-coated rod that extends into the catheter hub to eliminate bacteria, and can be used in place of regular end caps for a single use. The device won FDA approval in late 2013. The $2.1 million is the maximum the company was looking for in the round, according to the SEC filing. Money in the round came from 31 unnamed sources, though the company has not yet said how it plans to spend funds in the round. Last April, the company raised more than $5.1 million through a new equity offering. Executives disclosed the new cash infusion in a regulatory filing, though specific investors are not mentioned. Last February, Pursuit Vascular had secured $1.6 million in a debt and securities offering to 33 unnamed investors.
MEDTRONIC CLOSED A $1.1B ACQUISITION OF IMPLANTABLE CARDIAC PUMP MAKER HEARTWARE Medtronic closed the $1.1 billion acquisition of implantable cardiac pump maker HeartWare International in late August. HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation. The $58-per-share deal clears the field of the two major cardiac assist device makers, after Medtronic’s cross-town rival, St. Jude Medical, paid $3 billion for Thoratec in October 2015 (St. Jude is now being acquired by Abbott for $25 billion). The deal does not affect its fiscal 2017 forecast. HeartWare’s effect on earnings per share is expected to be zero to minimal for the first two years and accretive after that. “Not only does the current HeartWare portfolio expand Medtronic leadership across the heart failure continuum, its product pipeline – when married with our expertise – can result in progressively less-invasive heart pumps that have the potential to benefit even more patients,” GM Dr. David Steinhaus said. VT N
OCTOBER/NOVEMBER 2016 VEIN THERAPY NEWS