Healthcare Industry News: U.S. Food and Drug Administration
News Release - December 7, 2018
Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic ProtectionRALEIGH, N.C., Dec. 7, 2018 -- (Healthcare Sales & Marketing Network) -- Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection. Contego Medical is a medical device company developing and commercializing a suite of next-generation devices that address unmet needs in neurovascular, coronary and peripheral vascular disease.
The Vanguard IEP System uniquely incorporates a peripheral angioplasty balloon and distal embolic filter on the same catheter. The system protects the lower limbs during angioplasty without the need for additional devices or exchanges. The Vanguard IEP System has an over-the-wire design with a sheathless integrated 150-micron pore filter distal to the angioplasty balloon. Contego Medical's filter is the first to feature in-vivo adjustability to suit varying vessel sizes and maximize capture efficiency. Vanguard IEP was evaluated in the ENTRAP 112-patient post-market registry in Europe in which 100% of patients met primary safety and efficacy endpoints at discharge and 30 days.
"The Vanguard IEP System is designed to protect patients at high risk for embolization during peripheral angioplasty, such as those with acute limb ischemia, severe calcification, and chronic total occlusions if crossed intraluminally. It is also well suited to protect patients at high risk for complications should embolization occur, such as those with poor distal run-off," said Professor Thomas Zeller, Director of the Department of Angiology at Unversitaets Herzzentrum, Freiburg in Bad-Krozingen, Germany and Principal Investigator of the ENTRAP Study. "In our experience, the device has performed exactly as intended and we are impressed with the ease of use of the system, with no more exchanges required than in a typical angioplasty procedure."
"Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical," said Ravish Sachar, MD, Founder and CEO of Contego Medical. "As the patient population with peripheral arterial disease continues to expand and become more complex, we believe our technology will play a critical role in protecting vulnerable patients from embolic events and thus improve procedural outcomes." Contego Medical now has two FDA cleared devices dedicated to improving the safety profile and outcomes of interventional procedures.
The Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.
About Contego Medical
Contego Medical, LLC is a medical device company dedicated to the development of novel medical devices for neurovascular, cardiovascular and peripheral vascular procedures. The company's Integrated Embolic Protection (IEP) platform, which combines embolic protection and treatment into one device, is designed to simplify catheter-based procedures and improve patient outcomes.
Contego Medical and Vanguard IEP are trademarks of Contego Medical, LLC.
The Vanguard IEP System is covered by U.S. and foreign patents.
Source: Contego Medical
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