FDA Clears Atherectomy System for Minimally Invasive Treatment for PAD

 

September 9, 2008

Pathway Medical Technologies Inc. offers the Jetstream, a peripheral atherectomy catheter designed for use in the treatment of peripheral artery disease (PAD) in the lower limbs.

The device is capable of treating an entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions with consistent clinical results, the company said.

Jetstream offers a minimally invasive solution to clear blockages in the peripheral vasculature, restoring blood flow and effectively treating PAD. Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard IV stand. The catheter has an expandable cutting tip with rotating blades that safely debulk and pre-emptively 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.

September 2008