FDA grants Pathway 510(k) clearance for JETSTREAM G3 SF peripheral revascularization catheter for PVD

Jun 21 2010

Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral vascular disease (PVD), today announced that the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market JETSTREAM G3™ SF (Small Fixed), the newest version of its peripheral revascularization catheter for the treatment of PVD. The smaller size, fixed cutter and longer catheter length make JETSTREAM G3 SF an ideal option for treating blockages below the knee (BTK). JETSTREAM G3 SF allows physicians to treat a broader range of PVD patients, including the greater number of patients with critical limb ischemia and diabetes in the BTK population. JETSTREAM G3 will be showcased at the C3 Conference in Pathway Medical Technologies' booth, #211.

“Our ongoing commitment to innovation has helped solidify Pathway's position as a leader in the PVD market”

"The JETSTREAM G3 SF gives me a new tool in my arsenal to treat a wide range of PVD patients, including those with blockages in smaller arteries below the knee," said Dr. Malcolm T. Foster III, research director at East Tennessee Heart Consultants and physician at Mercy Medical Center West in Knoxville, Tenn. "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 CLI and saving their limb. My experience with the device has been extremely positive and I look forward to continuing to use this exciting innovation."

According to the Centers for Disease Control (CDC), more than 24 million Americans live with diabetes. The disease can cause poor circulation in the limbs and puts diabetics at higher risk of developing CLI, or a lack of blood supply in the legs, which can lead to amputation. In fact, the risk of losing a foot or leg is 15-40 times higher for diabetics than for those without the disease, according to the American Diabetes Association (ADA). Revascularization technologies, such as JETSTREAM, can help restore blood flow and save the limbs of diabetic patients. However, not all devices are designed to treat small blood vessels found in the lower legs.

JETSTREAM G3 SF is the only below-the-knee device on the market that offers active aspiration, a feature that continually removes debris from the treatment site. JETSTREAM G3 SF is optimized for below-the-knee blockages and features a smaller, fixed cutter designed for enhanced performance in tortuousity (curves) and better navigation of the device through arteries of the lower leg.

"Our ongoing commitment to innovation has helped solidify Pathway's position as a leader in the PVD market," said Paul Buckman, president and CEO, Pathway Medical Technologies. "Through continual expansion and refinement of JETSTREAM, we are now able to reach and help a varied population of PAD sufferers with minimally invasive treatment options, helping them recover and return more quickly to normal, active lives."

SOURCE Pathway Medical Technologies, Inc.