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FDA approves new catheter for treating PAD

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The FDA has approved a new scoring catheter as an alternative to balloon-based scoring in the treatment of peripheral artery disease, according to a press release.

The new catheter (FLEX Scoring Catheter, VentureMed Group Ltd.) is indicated for patients with severely blocked peripheral arteries for whom traditional balloon angioplasty is not as effective. The catheter received a CE mark in 2015.

“Using FLEX prior to balloon angioplasty in our first-in-man trial, we were able to show statistically significant improvement in ankle-brachial index scores at 30 days,” said John Pigott, MD, chief science officer, VentureMed Group, and vascular surgeon at the ProMedica health system in Michigan, in the release from the company. “Benefits for PAD patients may include fewer dissections and improved results at procedure completion.”

On the tip of the catheter are three precision micro-blades which are used to make continuous scores and loosen the plaque in the blocked artery, after which an angioplasty balloon opens up the artery to allow the blood to flow more freely, according to the release.

Disclosure: Pigott is an employee of VentureMed Group.