FDA Clears Atherectomy System for Minimally Invasive Treatment for PAD
September 5, 2008 - Pathway Medical Technologies Inc., today received FDA clearance to market Jetstream, a peripheral atherectomy catheter designed for use in the treatment of peripheral artery disease (PAD) in the lower limbs.
The clearance marks the company’s second 510(k) clearance and the first device on the market capable of treating an entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions with consistent clinical results.
About 12 million Americans suffer from the effects of PAD and many in this rapidly expanding patient population go undiagnosed. Commonly associated with high blood pressure, diabetes, heart disease, stroke and aging, PAD causes a build-up of plaque within the arteries that limits blood flow to the extremities. PAD can lead to severe limb pain, non-healing ulcers and critical limb ischemia and, if left untreated, can lead to gangrene, amputation and even death. The most common intervention for PAD has historically included highly-invasive procedures, including bypass surgery. Unfortunately, many patients are poor surgical candidates for whom surgery can be life threatening.
Jetstream offers a minimally invasive solution to clear blockages in the peripheral vasculature, restoring blood flow and effectively treating PAD. Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard IV stand. The catheter has an expandable cutting tip with rotating blades that safely debulk and pre-emptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised tissue and thrombus are continually aspirated from the peripheral treatment site through ports in the catheter tip to a collection bag located on the console. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. Active aspiration is a safety feature that minimizes the risk of distal embolization.
“Clinical data suggests that Jetstream is quite effective at debulking and treating vascular disease in the peripheral vasculature,” said William A. Gray, M.D., director of endovascular services, Center for Interventional Vascular Therapy, New York-Presbyterian Hospital. “I have seen the efficacy of the Pathway technology first hand in several cases in Germany and look forward to treating future atherectomy candidates.”
For more information: www.pathwaymedical.com
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