Pathway Medical’s Peripheral Plaque Drill Gets 510(k) Classification

Following up on last year’s FDA approval, Pathway Medical Technologies out of Kirkland, Washington just received European clearance to sell the Jetstream G2 NXT coronary drill across the continent. Previously named Pathway PV, the system clears clogged blood vessels and aspirates the debris out the back.

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.

Video animation of the device in action…
Press release: Pathway Medical Technologies Receives CE Mark for the Jetstream G2 NXT…
Product page: Jetstream G2…
Flashback: Pathway Medical Gets FDA OK for Company’s Peripheral Plaque Drill