FDA Clears VentureMed's Flex Scoring Catheter

June 7, 2016—VentureMed Group, Ltd. announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the Flex scoring catheter, an endovascular device that precisely and dynamically scores any length of atherosclerotic lesion as it passes through the femoral-popliteal anatomy. Flex received European CE Mark approval in 2015.

According to the company, Flex is a cost-effective alternative to balloon-based scoring with a one-size-fits-all platform technology. The vessel-preparation device provides for effective dynamic linear scoring with a lower propensity for barotrauma or vessel wall damage. The design allows the operator to easily prepare a diseased vessel in a single insertion without the need for multiple balloon inflations.

The catheter is inserted over an 0.018-inch guidewire (6-F compatible sheath) and threaded through the patient’s artery to a point just below the blockage. The interventionist pulls a thumb lever that exposes three precision atherotomes that are radially mounted at the tip of the catheter. As the catheter is drawn through the lesion, the blades make continuous microscores, relaxing the plaque. Next, the balloon is inflated to achieve luminal gain, allowing blood to flow freely.

VentureMed Group is a member of the ProMedica Innovations Incubator, a medical device and technology development and commercialization center that was established in 2012 to identify and commercialize medical devices and inventions to enhance patient care.

Vascular surgeon John Pigott, MD, is the founder and Chief Science Officer of VentureMed Group. In the company’s announcement, Dr. Pigott commented, “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. Benefits for [peripheral artery diease] patients may include fewer dissections and improved results at procedure completion. In fact, we continue to see encouraging data from early adopters across the European Union.”