Healthcare Industry News:  peripheral artery disease 

Devices Interventional FDA

 News Release - February 2, 2009

Pathway Medical Technologies Receives FDA 510(K) Clearance for Jetstream G2 System

New Technology Delivers Highly Effective, 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 the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market its newest peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs. Jetstream G2™ is the latest technology innovation from Pathway and is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results.

“Jetstream took conventional atherectomy procedures to the next level, enabling physicians to remove all types of both hard and soft tissue plaque with a single device and greatly improving the way patients are treated for peripheral artery disease,” said Pathway Medical Technologies President and CEO Paul Buckman, “Jetstream G2 is a major milestone for the company and the industry, and we firmly believe that this enhanced technology will significantly increase the number of PAD sufferers for whom atherectomy is a viable treatment option. Today’s news further underscores and validates Pathway’s continued commitment to delivering innovative technologies for the minimally invasive treatment of a condition that affects millions of people across the U.S.”

Approximately 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. Atherectomy — the removal of the blockage by inserting a tiny drill into the artery to remove the fatty buildup from the artery walls — has proven to be an effective, first-line option in minimally invasive PAD intervention. Yet, until now, atherectomy devices have not been effective in removing all types of hard and soft tissue plaque.

Jetstream G2 — Dramatically Improving Options for Physicians Treating PAD

Jetstream®, cleared by the FDA in September 2008, is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD. The 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 an expandable 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 system 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.

The new Jetstream G2 delivers design enhancements from the First-Generation Jetstream Catheter. New design features include:

  • Proximal Aspiration Port — The Jetstream G2 aspiration port is now separate from the cutting mechanism and located just proximal to the expandable cutting blades. As a result, the G2 provides greater aspiration efficiency and a more than 50 percent improvement in crossing time as compared to the Jetstream. In addition, a larger aspiration port allows for larger particles to be immediately removed from the treatment area.
  • Masticating System — Located within the new aspiration port is an internal masticating system. Positioned at the distal end of the catheter’s internal aspiration lumen, the system is fully recessed to ensure no contact with the artery walls during use and, importantly, helps break aspirated material into smaller pieces before removal through the aspiration port.

With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 maximizes treatment effectiveness with an average device activation time of about three and a half minutes during atherectomy treatment. Jetstream offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

“As one of the first physicians to use Jetstream G2 to treat PAD patients, I can say first hand that this new evolution of Pathway’s technology delivers not only the highest levels of safety and efficacy, but also improved performance,” said Dr. Steven Oweida, vascular surgeon at WellStar Kennestone Hospital and a partner at Vascular Surgical Associates in Marietta, Georgia. “Jetstream’s sophisticated aspiration system, further enhanced with the latest generation G2 device, allows me to clear and aspirate blockages more efficiently than ever before. I look forward to helping many more patients suffering from PAD with this innovative new technology.”

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 arteries by removing both hard and soft diseased tissue. For further information, visit the company’s Web site at

Source: Pathway Medical Technologies

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