KIRKLAND, Wash.--(BUSINESS WIRE)--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 the Jetstream G2™ specifically for use in breaking apart and removing thrombus (or blood clots) from the upper and lower extremity peripheral arteries. Jetstream G2, Pathway’s newest peripheral atherectomy catheter, is capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus, with consistent results.
“The new thrombectomy indication for Jetstream G2 helps us deliver on our commitment to meet the needs of PAD sufferers with innovative technology and continually bring value to our physician customers across the country,” said Pathway Medical Technologies President and CEO Paul Buckman. “In just the first six months on the market, Jetstream has been used to treat more than 600 patients at more than 100 centers of excellence. A significant leap forward in atherectomy, Jetstream G2 has enormous potential to revolutionize the PAD treatment market.”
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 specialized catheter 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.
About Jetstream G2
Jetstream G2, initially cleared by the FDA in January 2009, 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.
Jetstream G2 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. 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 maximizes treatment effectiveness. Jetstream G2 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® and Jetstream G2™ devices allow 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.
Contact:
Schwartz Communications for Pathway Medical Technologies Marisa Borgasano, 415-512-0770 PathwayMedical@schwartz-pr.com
