FDA Clears Contego Medical's Vanguard IEP Peripheral Angioplasty System
December 7, 2018—Contego Medical, LLC announced that the FDA has granted 510(k) clearance for the company's Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection (IEP). The device is indicated for percutaneous transluminal angioplasty and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal, and profunda arteries.
According to the company, the Vanguard IEP system 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 device's over-the-wire design with a sheathless integrated 150-µm pore filter distal to the angioplasty balloon. The filter features in vivo adjustability to suit varying vessel sizes and maximize capture efficiency.
Vanguard IEP was evaluated in the 112-patient postmarket ENTRAP study in Europe, in which 100% of patients met primary safety and efficacy endpoints at discharge and 30 days. The company announced European CE Mark approval in April 2017.
Professor Thomas Zeller, MD, who served as Principal Investigator of the ENTRAP study, "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. 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." Prof. Zeller is Director of the Department of Angiology at Unversitäts Herzzentrum, Freiburg in Bad-Krozingen, Germany.