Healthcare Industry News:  peripheral arterial disease 

Devices Interventional Regulatory

 News Release - December 14, 2009

Pathway Medical Technologies Receives CE Mark for the Jetstream G2 NXT

Opens the Door for European Marketing of Minimally Invasive Treatment for Entire Spectrum of Peripheral Artery Disease

KIRKLAND, Wash.--(HSMN NewsFeed)--Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral arterial disease (PAD), today announced that it received the CE Mark approval for its Jetstream G2TM NXT System, the company’s peripheral atherectomy catheter for use in the treatment of PAD. The CE Mark approval will allow the company to place the Jetstream G2 NXT on the market in all European Union countries, as well as other countries that accept this certification. Pathway Medical is now developing plans for commercialization in Europe.

“CE Marking is an important achievement for Pathway as we look forward to entering the European market and making a significant impact on a new marketplace,” said Pathway Medical Technologies President and CEO Paul Buckman. “We are excited about the opportunity to provide a new physician population with the latest PAD innovation and expanding on our promise to deliver the most effective, minimally invasive treatment for a condition that affects more than 27 million people in Europe and North America.”

In August, Pathway Medical announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Jetstream G2 NXT. The Jetstream G2 NXT is a peripheral atherectomy catheter designed to remove all types of artery-clogging plaque in the lower limbs of patients. Jetstream G2 NXT offers specific design enhancements to Pathway’s first-generation device, improving options for physicians treating PAD. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD.

About Jetstream G2 NXT

Jetstream G2 NXT 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 an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. A highly efficient aspiration port located just proximal to the cutting blades continually removes excised tissue and thrombus from the treatment site to a collection bag located on the console. A fully recessed masticating system within the aspiration port helps break aspirated material into smaller pieces before removal, providing significant benefits for the treating physician and patient while ensuring no contact with the artery walls. 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.

With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 NXT maximizes treatment effectiveness. Jetstream G2 NXT offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

About Pathway Medical Technologies, Inc.

Pathway Medical Technologies, Inc. was founded to design market and manufacture medical devices for the treatment of arterial disease. The company’s initial focus is treating peripheral arterial disease (PAD) more quickly and effectively than existing technologies. An estimated 12 million people are afflicted by PAD in the U.S. and that number is projected to grow to over 20 million during the next 10 years. The company’s Jetstream® device allows for a minimally invasive procedure designed to restore circulation in the peripheral vasculature by removing both hard and soft diseased tissue. For further information, visit the company’s Web site at www.pathwaymedical.com.


Source: Pathway Medical Technologies

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