Cardiovascular Procedures

Safe-Cross Total Occlusion Crossing System receives 510k peripheral clearance

Published in Medical Letter on the CDC and FDA, December 28th, 2003

Medical device manufacturer IntraLuminal Therapeutics, Inc., has received 510k clearance from the U.S. Food and Drug Administration to market its peripheral Safe-Cross Total Occlusion Crossing System.

The system is designed to give the interventionist real-time feedback as to the proximity of the crossing wire to the arterial wall plus the capability to use radio frequency power on the tip of the wire to assist in penetrating hardened material within the artery, thus facilitating safe and successful passage and placement of therapeutic devices for recanalization in native iliac and superficial femoral peripheral arteries.

The company anticipates a...

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Source: Medical Letter on the CDC and FDA (2003-12-28)

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