Pathway Medical Technologies Receives FDA 510(k) Clearance For JETSTREAM G3™ Atherectomy System

From: Medical News Today

Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral vascular disease (PVD), announced that the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market JETSTREAM G3™, its newest peripheral revascularization catheter for the treatment of PVD. With a new distal cutter and enhanced aspiration efficiency, JETSTREAM G3 offers a significant improvement in cutting and removing disease as compared to previous versions. JETSTREAM G3 is used for treating the entire spectrum of disease found in the PVD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions.

"JETSTREAM G3 is the next step in atherectomy treatment for peripheral vascular disease. These enhancements incorporate a new state-of-the-art cutter that will enable physicians to treat PVD more quickly, safely and effectively than any of the existing technologies," said Pathway Medical Technologies President and CEO Paul Buckman. "Over the past twelve months Pathway has made significant advances to our atherectomy system. We believe that JETSTREAM G3 now represents the definitive treatment for all lesion morphologies, including calcium and total occlusions. We are fully committed to the continued development of innovative medical devices for the treatment of vascular disease."

"The JETSTREAM device is a highly effective technology for the treatment of occlusive and thrombotic peripheral arterial disease," stated Tom Shimshak MD, an interventional cardiologist and Director of the Cardiovascular Laboratory and Medical Director of the Cardiovascular Institute, Wheaton Franciscan Healthcare, All Saints, Racine, Wisconsin. "The advances in the cutting tip and increased power in the JETSTREAM G3 device will be particularly desirable for long, diffusely diseased segments, including calcification, chronic total occlusions and traditional 'no-stent' zones."

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 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 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.