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 NavitusTM, an enhanced revascularization catheter for the treatment of PVD. Offering greater flexibility, unsurpassed 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, M.D., 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. The JETSTREAM Navitus will allow a wider spectrum of patients to benefit from this generational technology.”
“Navitus demonstrates our commitment to providing physicians with the best minimally invasive tools for treating the more than 12 million people in the U.S. who suffer from peripheral artery disease,” said Pathway Medical Technologies President and CEO Paul Buckman. “The power, flexibility and effectiveness of Navitus underscore Pathway’s position as the leading innovator of PVD technology. We look forward to continuing to lead the market with cutting-edge products that are quickly gaining acceptance from leading physicians across the country.”
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 unsurpassed differential cutting effectiveness that make it ideal for treating even the most difficult and substantial blockages.
- Active Aspiration—The JETSTREAM family of products remain the only atherectomy devices on the market to offer active aspiration. This feature allows the operator to continually aspirate (remove) 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.
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 block the normal flow of blood. PAD can cause pain and eventually lead to immobility in affected limbs. People with PAD often have fatty buildups 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 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.