(The following press release from Bayer was received by e-mail. It was not confirmed by the sender.) News-Release Not intended for U.S. and UK Media Bayer’s AngioJet® Ultra thrombectomy system demonstrates efficacy in treatment of peripheral arterial diseases 89 percent limb salvage rate in patients with acute limb ischemia / 84 percent of DVT patients maintained freedom from rethrombosis 12 months following treatment / statistically significant improvements in patients’ quality of life seen at three, six and 12 months Tarrytown, September 23, 2013 - Final data from the first prospective, multi-center registry evaluating the safety and efficacy of Bayer’s AngioJet® Ultra Thrombectomy System in the treatment of peripheral venous and arterial diseases demonstrated an immediate improvement in blood flow in more than 90 percent of all vessels treated. The data showed an 89 percent limb salvage rate in patients with acute limb ischemia, while 84 percent of patients with deep vein thrombosis (DVT) were free from reoccurrance 12 months following treatment. Statistically significant improvements in quality of life also were demonstrated at three, six and 12 months. The first two subset analyses of the PEripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths (PEARL) Registry were presented this week at the Cardiology and Interventional Radiology Society of Europe Annual Meeting (CIRSE) in Barcelona. "The PEARL registry data has demonstrated that AngioJet alone or in combination with lytic agents is an effective treatment, with a favorable safety profile, in patients with acute, subacute and chronic DVT and limb ischemia," said Alan Main, President of Bayer HealthCare’s Medical Care Division and Member of the Bayer HealthCare Executive Committee. "Treatment with the AngioJet may reduce the need and infusion time for catheter directed thrombolysis (CDT) which can help improve a patient’s quality of life and reduce the economic burden on the healthcare system." Limb ischemia Among patients with arterial limb ischemia, there was an average 90 percent reduction of occlusion at procedure’s end. Angiography showed a 93 percent improvement in the 947 treated vessels (p<0.0001) with the majority of the patients (80 percent) with a procedural duration of less than 24 hours. "Treatment with AngioJet is equally effective in acute and chronic thrombus, and notably there was a limb salvage rate of 89 percent among the acute arterial patients with Rutherford classifications of IIa, IIb and III," said Andrej Klepanec, M.D., Ph.D., Department of Diagnostic and Interventional Radiology, National Institute of Cardiovascular Disease, Bratislava. Patients in the arterial arm who were followed one year post treatment maintained a statistically significant improvement in quality of life scores on both mental (p<0.0001) and physical (p<0.0001) components. Deep vein thrombosis Among patients with DVT venographic analysis showed a statistically significant improvement in the thrombus burden (97 percent of 1,295 treated vessels demonstrated improvement; p<0.0001), across all treatment techniques and regardless of when symptom onset commenced. The 371 DVT patients were followed three, six and 12 months post treatment to assess safety, clinical benefit and quality of life. One year post-treatment, 84 percent of DVT patients maintained freedom from rethrombosis and a statistically significant improvement in quality of life. Nearly 90 percent of patients were treated using pharmacomechanical techniques in which AngioJet is used to directly infuse the agent into the clot prior to deploying the device’s mechanical thrombectomy functionality. The use of AngioJet pharmacomechanical technique demonstrated a statistically significant reduction in CDT drip time with fewer bleeding complications as compared to previous studies*. * Venous Registry or CaVenT trial. PEARL Registry suggests potential to reduce cost of DVT treatment Approximately 1 million people are treated for DVT in the US and Europe annually. The DVT arm of the registry suggests that AngioJet alone, or with lytic delivered through its power pulse technology, is as effective as standard of care for DVT which includes lytic administered by CDT, and reduces costly hospital intensive care unit (ICU) time. Lytic administration by CDT generally occurs in the ICU for an average of two days. For example, in the US where the average daily cost of care in the ICU is $5000 there may be a significant benefit for patients and the healthcare system by reducing or eliminating ICU-based CDT treatment. About the PEARL Registry Conducted from January 2007 through June 2013 at 46 centers in four countries the PEripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths (PEARL) was a two-phase registry that evaluated the use of the AngioJet Thrombectomy System in the peripheral vascular system of 952 patients. Forty-three percent of patients were treated for arterial limb ischemia; 39 percent for DVT, 15 percent for thrombosed hemodialysis access sites and three percent for other forms of thrombosis. Safety and tolerability in the study were generally consistent with the known profile of AngioJet or other endovascular procedures. Data for the hemodialysis access subset will be presented in November at VEITH Symposium and a full study report is in development and is expected to be published next year. About the AngioJet® Ultra Thrombectomy System The AngioJet Ultra Thrombectomy System employs a unique technology to break apart and remove blood clots from within peripheral vasculature. High-speed saline jets inside the AngioJet catheter create a powerful low pressure zone that pulls thrombus into the catheter and removes it from the body. The core technology, AngioJet Thrombectomy, has been used in more than 600,000 cases worldwide and among the leading choices for eliminating large thrombus burden. The AngioJet Ultra Thrombectomy Console features an advanced control system that automatically detects the catheter model and configures the console to meet the requirements of each catheter. Throughout the procedure the Ultra Console monitors system performance to ensure the procedure is running smoothly. Runtime and infused fluid volume displays provide information and offer physician convenience. The Ultra Series Thrombectomy Set integrates the pump and the catheter into a single unit for fast and easy loading. Indications, operating specifications and availability may vary by country. Check with local product representation and country-specific Information For Use for your country. 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 18.6 billion (2012), 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 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at http://www.healthcare.bayer.com. Our online press service is just a click away: http://press.healthcare.bayer.com Follow us on facebook: http://www.facebook.com/healthcare.bayer Follow us on Twitter: https://twitter.com/BayerHealthCare Information for editors: Photos are available for download at http://www.press.bayer.com. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments Contact: Christina Clinton, Tel. + 1 914-333-6923 E-Mail: mailto:firstname.lastname@example.org This press release is available here: http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0536-e Yours BayNews Editorial Team Bayer AG Communications Building W11 51368 Leverkusen, Germany --------------------------------------------------- Further news releases you can find here: http://www.press.bayer.com To ensure receipt, please add email@example.com to your address book or list of trusted senders. --------------------------------------------------- © Bayer AG, 51368 Leverkusen, Germany All rights reserved. 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BAYER’S ANGIOJET DEMONSTRATES EFFICACY IN TREATMENT (ENGLISH)
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