The Silverhawk device from EV3 and the Diamondback (Cardiovascular Systems Inc csii) now have additional pressure from the Jetstream G2 (Pathway Medical Technologies Inc) which has recently received 510 (k) clearance for removal of thrombus (mechanical thrombectomy) on the upper and lower extremities.
This represents a significant theoretical competitive advantage for the Jetstream G2 which now has multiple FDA approved applications for the treatment of Peripheral Arterial Disease (PAD).
From Medical News Today
Pathway's newest peripheral atherectomy catheter, is capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus, with consistent results
Jetstream G2 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. 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 maximizes treatment effectiveness. Jetstream G2 offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.
The Atherectomy Space has over a short period of time rapidly evolved with iterations on the first generation Silverhawk device to the current JetStream which has multiple applications (atheroma, calcium, thrombus) with a single device. Although, I dont personally have experience with this G2 system, It's clear that if the device behaves as touted, it may be a revolutionary advance.
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Posted by: air yeezy | November 04, 2010 at 08:11 PM