VentureMed Group recently announced that the US Food and Drug Administration (FDA) cleared the company’s Flex Vessel Prep system for use in the treatment of in-stent restenosis in the peripheral vasculature.
Within two years of undergoing stent implantation for femoropopliteal disease, nearly 30–40% of patients experience excessive tissue growth inside the surface of the stent and a recurrence of the narrowed artery which restricts blood flow (e.g., in-stent restenosis), a press release claims.
According to VentureMed, the Flex Vessel Prep system safely and effectively modifies plaque and fibrous stenoses by creating controlled-depth micro-incisions of any length to release the circumferential tension to improve vessel compliance and increase lumen gain.
Eric A Secemsky, director of Vascular Intervention at Beth Israel Deaconess Medical Center (Boston, USA), stated “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. The novel way in which the Flex system incises along the entire length of challenging ISR lesions appears to help facilitate and optimise treatment of these vessels, including the delivery of drug-coated therapies.”
“This expanded in-stent restenosis indication for Flex provides physicians with a safe and effective tool to address an increasingly common and difficult condition that can result from the implantation of stents to treat femoropopliteal disease,” said J Robert Paulson, Jr, president and chief executive officer of VentureMed.
“Flex allows physicians to modify plaque and prepare diseased vessels of any length to optimise their choice of definitive revascularisation therapy, and now as part of treating patients with femoropopliteal in-stent restenosis, helping to reduce the risk of recurrent in-stent restenosis.”