Atherectomy System Cleared for Use Below the Knee


June 22, 2010

June 22, 2010 – The U.S. Food and Drug Administration (FDA) recently granted 510(k) clearance for the Jetstream G3 Small Fixed (SF) peripheral atherectomy catheter. It is smaller than previous versions of the Jetstream, and offers a fixed cutter and longer catheter to treat 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 Complex Cardiovascular Catheter Therapeutics (C3) Conference.

“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 Malcolm T. Foster III, M.D., 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 to 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 continuously 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.

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