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Pathway Medical Technologies Announces FDA 510(k) Clearance for Jetstream Navitus

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Pathway Medical Technologies Announces FDA 510(k) Clearance for Jetstream Navitus

06/06/2011

KIRKLAND, WA––June 6, 2011––Pathway Medical Technologies, Inc , offering endovascular treatments for peripheral vascular disease (PVD), announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market Jetstream Navitus™, an enhanced revascularization catheter for the treatment of PVD. Offering greater flexibility, cutting effectiveness and improved guidewire performance, Jetstream Navitus is a highly effective option for treating calcium blockages and chronic total occlusions (CTOs) in the PVD patient population. Jetstream Navitus is now available for sale throughout the United States.

“The Jetstream Navitus offers interventionalists an evolutionary new tool to treat the most calcified lesions in the infra-inguinal vascular space,” says Andrey Espinoza, MD, FACC, FSCAI, medical director at Hunterdon Medical Center in New Jersey. “The design iterations provide a superior cutting platform with enhanced flexibility and an excellent deliverability profile.”

New features and benefits of Jetstream Navitus include:

· Improved performance in tortuous anatomy: Enhanced drive line design provides for coaxial guidewire movement through the length of the catheter, offering enhanced flexibility, reduced friction and smooth movement through the curves of the peripheral vasculature.

· Highly effective therapy for calcium and CTOs: Navitus provides front-end cutting and differential cutting effectiveness that make it ideal for treating even the most difficult and substantial blockages.

· Active aspiration: This feature allows the operator to continually aspirate excised tissue and thrombus while the device is operating. Unlike other competitive products that require users to stop treatment and empty collection chambers or simply deposit debris in the arterial beds downstream, Jetstream’s active aspiration is an important safety feature that both reduces procedure time and minimizes the risk of distal embolization.

· Single device solution: Navitus features expandable blade technology that enables treatment of blockages from the superficial femoral artery to below the knee, empowering physicians to treat all lesion morphologies.

Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has a cutting tip that safely debulks and preemptively 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 a port 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.

Jetstream offers simple set up and an ergonomic design for easy operation by trained clinicians. It offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

For further information, visit the company’s website at www.pathwaymedical.com .

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