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October 21, 2020

FDA Clears In-Stent Restenosis Indication for VentureMed’s Flex Vessel Prep System

October 21, 2020—VentureMed Group, Inc., announced that the FDA cleared a new indication for the company’s Flex vessel preparation (VP) system for use in the treatment of in-stent restenosis (ISR) in the peripheral vasculature.

According to the company, the Flex VP system was designed to modify plaque and fibrous stenoses by creating controlled-depth microincisions of any length to release the circumferential tension to improve vessel compliance and increase lumen gain. The device can treat the entire length of complex lesions of varying morphology. The device has received FDA 510(k) clearance in the United States and European CE Mark approval.

“Modifying the obstructive neointimal tissue that frequently forms within peripheral stents is clinically challenging but essential to effectively restore blood flow and maintain vessel patency,” commented Eric A. Secemsky, MD, in VentureMed’s press release. “The novel way in which the Flex system incises along the entire length of challenging ISR lesions appears to help facilitate and optimize treatment of these vessels, including the delivery of drug-coated therapies.” Dr. Secemsky is Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

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