FDA grants 510(k) approval for Vanguard IEP Peripheral Balloon Angioplasty System.- Contego Medical

Contego Medical announced that the 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 ."