For entire spectrum of peripheral artery disease
Pathway Medical has received the CE Mark approval for its Jetstream G2 NXT system, the company’s peripheral atherectomy catheter for use in the treatment of peripheral arterial disease (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 commercialisation in Europe.
The company claims that in August, it has received 510(k) clearance from the 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 minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD, said the company.
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.
Jetstream G2 NXT maximises treatment effectiveness and offers the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications, said the company.
Paul Buckman, president and CEO of Pathway Medical, said: “CE Marking is an achievement for Pathway as we look forward to enter the European market and making a significant impact on a new marketplace.
“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.”