KIRKLAND, Wash.--(BUSINESS WIRE)--Pathway Medical Technologies, Inc, an innovator of 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 G3™ SF (Small Fixed) 1.6 mm revascularization catheter for the treatment of PVD. First introduced in mid-2010, JETSTREAM G3 SF is a small catheter optimized for treating blockages in arteries below the knee (BTK). The addition of the 1.6 mm catheter to the JETSTREAM G3 SF family of products provides physicians with a broader array of treatment options for patients in need of BTK therapy, including the greater number of patients suffering from critical limb ischemia (CLI) and diabetes.
The JETSTREAM G3 SF family of products features a small, fixed cutter and longer catheter length designed for enhanced performance in tortuousity (curves) and better navigation of the device through smaller arteries in the lower leg. JETSTREAM G3 SF is still the only BTK device on the market to offer active aspiration, a feature that continually removes debris from the treatment site while the device is operating, helping reduce the potential for distal embolization. The new 1.6 mm JETSTREAM G3 SF catheter offers physicians expanded device options for treating patients with blockages in the small arteries of the lower leg, including those with heavy calcification and Chronic Total Occlusions (CTOs) common in BTK vessels.
“I have experienced the power and flexibility of the JETSTREAM G3 product line first hand while treating a wide spectrum of PVD patients and was impressed with the performance of the new 1.6 mm device,” said Anderson P. Mehrle. M.D., interventional cardiologist at Jane Phillips Medical Center in Bartlesville, Oklahoma and one of the first physicians to perform a case using the 1.6 mm catheter. “The sophisticated, yet simple, design will enable me to treat even the most complex occlusions in small vessels of the lower leg and allow me to offer a minimally invasive treatment option to a larger population of PVD sufferers.”
Today’s announcement comes on the heels of Pathway’s launch of JETSTREAM Navitus™ on June 6. JETSTREAM Navitus, which is also designed for enhanced flexibility in tortuous anatomy, offers unsurpassed differential cutting effectiveness, improved guidewire performance and expandable blade technology that enables treatment of blockages from the superficial femoral artery to below the knee in a single device.
“The latest addition to our JETSTREAM family delivers an excellent safety profile, consistent patient outcomes and enhanced performance for smaller peripheral arteries,” said Pathway Medical Technologies President and CEO Paul Buckman. “With each new device we introduce, Pathway expands the number of patients who can benefit from our minimally invasive technologies that help them get past PVD and back to lives with less pain faster than ever before.”
About Peripheral Vascular Disease (PVD)
Peripheral vascular disease (PVD) refers to diseases of the blood vessels outside of the heart and brain and is often associated with a narrowing of blood vessels in the legs, arms, stomach or kidneys. Peripheral arterial disease (PAD) is a type of PVD where fatty buildup (atherosclerosis) in the wall of the artery blocks the normal flow of blood. PAD can cause pain and eventually lead to immobility in affected limbs. People with PAD often have fatty buildup in the arteries of the heart (coronary artery disease) and of the brain (carotid artery disease) and have a higher risk of death from stroke and heart attack. PAD is estimated to afflict as many as 12 million people in the United States, according to the Society of Interventional Radiology (SIR), and as many as 27 million in Europe and North America combined, according to the American Heart Association. Incidence of PAD is generally higher in older age groups and affects approximately one out of every five people aged 55 and older.
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 a port in the catheter tip to a collection bag located on the console. The distal portion of the catheter also has 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.