KIRKLAND, Wash. & BALTIMORE--(BUSINESS WIRE)--Complex Cardiovascular Catheter Therapeutics (C3) Conference--Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral vascular disease (PVD), today announced that the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market JETSTREAM G3™ SF (Small Fixed), the newest version of its peripheral revascularization catheter for the treatment of PVD. The smaller size, fixed cutter and longer catheter length make JETSTREAM G3 SF an ideal option for treating 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 C3 Conference in Pathway Medical Technologies’ booth, #211.
“Through continual expansion and refinement of JETSTREAM, we are now able to reach and help a varied population of PAD sufferers with minimally invasive treatment options, helping them recover and return more quickly to normal, active lives.”
“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 Dr. Malcolm T. Foster III, 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 15-40 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 continually 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.
“Our ongoing commitment to innovation has helped solidify Pathway’s position as a leader in the PVD market,” said Paul Buckman, president and CEO, Pathway Medical Technologies. “Through continual expansion and refinement of JETSTREAM, we are now able to reach and help a varied population of PAD sufferers with minimally invasive treatment options, helping them recover and return more quickly to normal, active lives.”
About JETSTREAM
JETSTREAM is a peripheral revascularization 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 PVD. 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 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.
With simple set up and an ergonomic design for easy operation by trained clinicians, JETSTREAM maximizes treatment effectiveness and 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 vascular 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 www.pathwaymedical.com.
Contacts
Schwartz Communications for Pathway Medical Technologies Marisa Borgasano, 781-684-0770 PathwayMedical@schwartz-pr.com
