Jetstream G2 is granted FDA’s clearance


Pathway Medical Technologies has announced that the FDA has granted the company 510(k) clearance to market its newest peripheral atherectomy catheter for use in the treatment of peripheral arterial disease in the lower limbs. Jetstream G2 is the latest technology innovation from Pathway and is capable of treating the entire spectrum of disease found in the peripheral arterial disease patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results.

Jetstream, cleared by the FDA in September 2008, is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD. The 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 that safely debulks and preemptively 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 a port system 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.

The new Jetstream G2 delivers design enhancements from the First-Generation Jetstream Catheter. New design features include:

Proximal Aspiration Port – The Jetstream G2 aspiration port is now separate from the cutting mechanism and located just proximal to the expandable cutting blades. As a result, the G2 provides greater aspiration efficiency and a more than 50 percent improvement in crossing time as compared to the Jetstream. In addition, a larger aspiration port allows for larger particles to be immediately removed from the treatment area.

Masticating System – Located within the new aspiration port is an internal masticating system. Positioned at the distal end of the catheter’s internal aspiration lumen, the system is fully recessed to ensure no contact with the artery walls during use and, importantly, helps break aspirated material into smaller pieces before removal through the aspiration port.

Jetstream G2 maximises treatment effectiveness with an average device activation time of about three and a half minutes during atherectomy treatment. Jetstream offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.