Medical: CE Mark for the Jetstream G2 NXT

The Jetstream G2 NXT System from Pathway Medical Technologies Inc. has received the CE Mark approval. Jetstream G2 NXT is the company’s peripheral atherectomy catheter for use in the treatment of PAD. The CE Mark approval will allow the company to place the Jetstream G2 NXT on the market in all European Union countries, as well as other countries that accept this certification. Pathway Medical is now developing plans for commercialization in Europe.

“CE Marking is an important achievement for Pathway as we look forward to entering the European market and making a significant impact on a new marketplace,” says Pathway Medical Technologies President and CEO Paul Buckman. “We are excited about the opportunity to provide a new physician population with the latest PAD innovation and expanding on our promise to deliver the most effective, minimally invasive treatment for a condition that affects more than 27 million people in Europe and North America.”

In August, Pathway Medical announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Jetstream G2 NXT. The Jetstream G2 NXT is a peripheral atherectomy catheter designed to remove all types of artery-clogging plaque in the lower limbs of patients. Jetstream G2 NXT offers specific design enhancements to Pathway’s first-generation device, improving options for physicians treating PAD. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD.

About Jetstream G2 NXT
Jetstream G2 NXT 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, providing significant benefits for the treating physician and patient while ensuring no contact with the artery walls. 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 NXT maximizes treatment effectiveness. Jetstream G2 NXT offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.