February 3, 2009 - The FDA has granted Pathway Medical Technologies Inc., 510(k) clearance to market its newest peripheral atherectomy catheter, the Jetstream G2, for use in the treatment of peripheral artery disease (PAD) in the lower limbs.
Jetstream G2 reportedly is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results.
Atherectomy — the removal of the blockage by inserting a tiny drill into the artery to remove the fatty buildup from the artery walls — has proven to be an effective, first-line option in minimally invasive PAD intervention.
The Jetstream is a peripheral atherectomy catheter said to clear blockages in the peripheral vasculature, restore blood flow. The Jetstream 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 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 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.
Enhanced features of the new Jetstream G2 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, reportedly resulting in 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.
“As one of the first physicians to use Jetstream G2 to treat PAD patients, I can say first hand that this new evolution of Pathway’s technology delivers not only the highest levels of safety and efficacy, but also improved performance,” said Steven Oweida, M.D., vascular surgeon at WellStar Kennestone Hospital and a partner at Vascular Surgical Associates in Marietta, GA. “Jetstream’s sophisticated aspiration system, further enhanced with the latest generation G2 device, allows me to clear and aspirate blockages more efficiently than ever before. I look forward to helping many more patients suffering from PAD with this innovative new technology.”
For more information: www.pathwaymedical.com.