FDA Clears Updated Revascularization Catheter for Below-the-Knee Blockages

Yael Waknine

June 28, 2010

June 28, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new version of a peripheral revascularization catheter (Jetstream G3 Small Fixed [SF]; Pathway Medical Technologies, Inc) for the treatment of blockages related to peripheral vascular disease below the knee.

The updated device's smaller-sized fixed cutter and longer catheter length are designed to facilitate the treatment of blockages below the knee that occur in patients with critical limb ischemia and diabetes. According to a company news release, it is the only below-the-knee implement to feature continual aspiration of debris from the treatment site, thereby minimizing the risk for distal embolization.

"The Jetstream G3 SF gives me a new tool in my arsenal to treat a wide range of [patients with peripheral vascular disease], including those with blockages in smaller arteries below the knee," said Malcolm T. Foster III, MD, research director at East Tennessee Heart Consultants and a physician at Mercy Medical Center West in Knoxville, Tennessee, in a company news release. "In particular, patients with diabetes have often faced the threat of amputation due to poor circulation in the extremities. With Jetstream, some of these patients now have a viable option for treating [critical limb ischemia] and saving their limb."

The FDA previously granted 510(k) clearance for the company's Jetstream G3 and Jetstream G2 systems for the treatment of blocked peripheral arteries with a diameter of 3.0 mm or greater.