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Contego Medical wins US FDA 510(k) clearance for the Vanguard IEP Peripheral Angioplasty System with integrated embolic protection.

M2 EQUITYBITES-December 10, 2018-Contego Medical wins US FDA 510(k) clearance for the Vanguard IEP Peripheral Angioplasty System with integrated embolic protection

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Medical device company Contego Medical revealed on Friday the receipt of the US Food and Drug Administration (FDA) 510(k) clearance for its Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection indicated for percutaneous transluminal angioplasty (PTA).

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. The Vanguard IEP System is not intended for use in the renal, cerebral, coronary or carotid vasculature.

According to the company, 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.

In conjunction, the company's filter is the first to feature in-vivo adjustability to suit varying vessel sizes and maximize capture efficiency. The 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.

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Publication:M2 EquityBites (EQB)
Date:Dec 10, 2018
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