July 13, 2016 — VentureMed Group Ltd., specializing in devices for the endovascular treatment of peripheral arterial disease (PAD), announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Flex Scoring Catheter.
The catheter is an endovascular surgical device that precisely and dynamically scores any length atherosclerotic lesion as it passes through the femoral-popliteal anatomy. Flex provides an alternative to balloon-based scoring with a one-size-fits-all platform technology.
VentureMed Group founder and chief science officer John Pigott, M.D., said the first-in-man trial of the device showed statistically significant improvement in ankle-brachial index scores at 30 days.
FDA clearance of Flex, which received CE Mark in Europe in 2015, will provide interventionalists with a vessel preparation device that allows 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 (6F compatible sheath) and threaded through the patient’s artery to a point just below the blockage. The surgeon 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 micro-scores, relaxing the plaque. Next, the balloon is inflated to achieve luminal gain, allowing blood to flow freely.
For more information: www.venturemedgroup.com