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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.

The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection platform is similar to a catheter with a typical angioplasty balloon, but between the distal end of the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device is over-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizes of 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filter component is composed of a nitinol filter frame with an overlying membrane perforated with a set pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaft placed inside a single lumen outer shaft. The inner shaft extends beyond the balloon up to the distal catheter tip. Radiopaque markers placed on either side of the balloon and the distal tip of the filter assist with accurate placement. The nitinol filter frame has radiopaque markers, making the diameter of the filter visible when opened. The proximal end of the nitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filter frame to activate the filter.

Here's a breakdown of the acceptance criteria and study information for the Contego Medical Vanguard IEP Peripheral Balloon Angioplasty System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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