Leverkusen, September 14, 2012 – The Medical Care division of Bayer HealthCare is introducing its Jetstream™ Atherectomy System at the 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. 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).

“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 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 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.

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.

“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.”

About Jetstream
The Jetstream System is an innovative peripheral revascularization platform designed to restore flow through the many types of occlusive material encountered in peripheral arterial disease (PAD). Offering a range of sizes to treat vessels above and below the knee, the Jetstream 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 System is the only atherectomy technology on the market to offer 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.

With unique technologies and features that provide effective atherectomy in difficult arterial obstructions while preserving options for further treatment, the Jetstream System gives physicians a powerful tool to help fight PAD.

About Peripheral Arterial Disease
Peripheral Arterial Disease (PAD) occurs when blood flow to the limbs becomes restricted and affects an estimated 27 million people in Europe. The most common cause of PAD is atherosclerosis, often called "hardening of the arteries", in which cholesterol and scar tissue build up, forming a substance called "plaque" that clogs the blood vessels. In some cases, PAD may be caused by blood clots that lodge in the arteries and restrict blood flow. Left untreated, this insufficient blood flow will lead to limb amputation in some patients.

Upon suspicion of PAD, the first-line study is the ankle brachial pressure index (ABPI/ABI). When blood pressure readings in the ankles are lower than that in the arms, blockages in the arteries which provide blood from the heart to the ankle are suspected. The severity of the PAD is commonly classified using the Rutherford or Fontaine classification systems.

Up to one third of patients will require a surgical or radiological intervention. Historically, PAD treatment included highly-invasive procedures, such as bypass surgery. More recently, less-invasive techniques have emerged – these involve inserting a catheter through the skin and into the blood vessel to clear a blockage and restore circulation to the extremities. These less invasive treatment options offer patients faster recovery and decreased systemic complications while delivering renewed hope for non-surgical candidates.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.

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