Bayer’s Jetstream™ Atherectomy System Brings Active Aspiration to European Markets

The Medical Care division of Bayer HealthCare is introducing its Jetstream™ Atherectomy System at the next week’s annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Lisbon, Portugal. The device can be used to treat a wide range of vessel diameters and features continuous active aspiration, which continually removes excised stenotic material and thrombus from the treatment site and delivers it to a collection bag located on the console..

A unique technology allowing its use in thrombus, soft plaque and calcified lesions, the Jetstream device offers an additional treatment option for the millions of Europeans suffering from peripheral artery disease (PAD).

Background

Bayer describes its Jetstream System as an innovative peripheral revascularization platform designed to restore flow through the many types of occlusive material encountered in PAD. Offering a range of sizes to treat vessels above and below the knee, the system consists of a single-use catheter with control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has a unique, front-facing cutting tip that debulks both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions.

The Jetstream Navitus™ catheter is designed for enhanced flexibility in complex anatomy and offers unique expandible blade technology which enables the physician to treat blockages in vessels from the superficial femoral artery to below the knee with a single device.

The 1.6 mm and 1.85 mm Jetstream G3 SF catheters feature small, fixed cutters and longer catheter lengths for better navigation through the tortuous smaller arteries below the knee where heavy calcification and Chronic Total Occlusions (CTOs) are common.

All Jetstream catheters offer differential cutting technology which cuts through occlusive material but preserves the soft tissue of the vessel walls.

Physician comments

“Jetstream is a highly effective technology for the treatment of chronic occlusive and thrombotic peripheral arterial disease,” according to Thomas Zeller, M.D., of the Department of Angiology, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany, and co-principal investigator of pivotal European multi-center clinical trial for Jetstream technology. “In the pivotal study of 172 patients, many of whom had more than one lesion, we successfully restored flow through 99 per cent of the lesions and demonstrated significant clinical improvement post-procedure at 30 days, six and 12 months on both Rutherford and ABI scores.”

“The device allows us to quickly restore blood flow to the limbs by removing calcifications in diffusely diseased segments – including traditional zones where stents cannot be used – without the higher risks inherent in surgery,” said Anderson Mehrle, M.D., of Jane Phillips Medical Center in Bartlesville, OK; USA. Mehrle is among the speakers at a satellite symposia Bayer is sponsoring at CIRSE 2012, on September 15.

Company comments

“The addition of the Jetstream technology demonstrates Bayer’s comprehensive approach and commitment to offer treatment options to the estimated 27 million people in Europe and North America who have peripheral artery disease,” said Alan Main, President of Bayer HealthCare Medical Care. “We’re thrilled to bring this atherectomy device to the European market alongside our full-range of products including the Medrad Mark 7 Arterion™ Fluid Delivery System for use in diagnostic angiograms and the AngioJet™ family of thrombectomy devices for the removal of intravascular thrombus in the upper and lower extremities.”

Source: Bayer HealthCare.