Pathway Medical’s Jetstream G2 NXT Receives CE Mark

December 14, 2009—Pathway Medical Technologies, Inc. (Kirkland, WA) announced that it has received CE Mark approval for its Jetstream G2 NXT system, which is a peripheral atherectomy catheter for use in treating peripheral arterial disease. The company stated that it is developing plans for commercialization of the device in Europe, as well as other countries that accept the CE Mark certification. In August, Pathway Medical announced 510(k) clearance from the US Food and Drug Administration to market the Jetstream G2 NXT.

According to the company, the Jetstream G2 NXT is designed to remove all types of artery-clogging plaque in the lower limbs of patients and features design enhancements on Pathway’s first-generation device. The device clears blockages in the peripheral vasculature, restores blood flow, and effectively treats peripheral arterial disease.

Jetstream G2 NXT consists of a sterile, single-use catheter and a control pod. 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. It is ergonomically designed to maximize treatment effectiveness and offer nonsurgical candidate patients the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications, the company stated.