First Patients in Europe Treated with Cardiovascular Systems, Inc. Peripheral Orbital Atherectomy System
ST. PAUL, Minn.--(BUSINESS WIRE)--Nov 13, 2018--Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patients in Germany have been treated with its Stealth 360 ® Peripheral Orbital Atherectomy System (OAS). The German cases represent the first commercial use of Peripheral OAS in Europe.
Dr. Tobias Achenbach, head of the Radiology Department at the St. Vincenz Hospital, Köln, where the first patients in Germany were treated by his colleagues Dr. Reza Asady and Dr. Ingo Benz, said, “CSI’s minimally invasive orbital atherectomy technology allows physicians to gently modify calcified plaque and enables peripheral revascularization for patients with severely calcified arteries. The introduction of orbital atherectomy in Germany greatly improves the treatment options for my patients suffering from peripheral artery disease, or PAD.”
Prof. Dierk Scheinert, Head of the Department of Medicine, Angiology and Cardiology, Park-Krankenhaus Leipzig, and Head Department of Angiology, University Hospital Leipzig Heart Center, Leipzig, Germany said, “Of those suffering from PAD, many progress to critical limb ischemia, or CLI, the most severe and potentially deadly form of PAD. If left untreated, CLI can lead to amputation. The unique ability of orbital atherectomy to safely treat calcified peripheral lesions, both above and below the knee, will allow physicians in Germany to help a very challenging patient population.”
Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, “By leveraging our international distribution partner, OrbusNeich, we are demonstrating our ability to rapidly introduce our OAS technology to physicians worldwide. We look forward to training many more physicians that share our passion for improving the outcomes of patients suffering from peripheral and coronary artery disease.”
In July 2018, CSI announced that it had signed an exclusive international distribution agreement with OrbusNeich to sell its coronary and peripheral OAS outside of the United States and Japan.
About Cardiovascular Systems, Inc. Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s OAS treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360 ® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over 400,000 of CSI’s devices have been sold to leading institutions worldwide.
About OrbusNeich OrbusNeich ® is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world’s first dual therapy stents, the COMBO ® Plus and COMBO ® Dual Therapy Stents, together with stents and balloons marketed under the names of Azule ®, Scoreflex ®, Sapphire ® II, Sapphire ® II PRO and Sapphire ® II NC, as well as products to treat peripheral artery disease: the Jade ® and Scoreflex ® PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com.
Safe Harbor Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding anticipated future introduction of CSI devices outside of the United States and Japan; the specific OrbusNeich products to be offered by CSI in the United States; and the sale of CSI products in Japan, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, regulatory developments, clearances and approvals; approval of our products for distribution in countries outside of the United States; approval of our products for reimbursement in and the level of reimbursement; the ability of OrbusNeich to successfully launch CSI products outside of the United States and Japan; the experience of physicians regarding the effectiveness and reliability of CSI’s products; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; general economic conditions; international trade developments; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.
Product Disclosure The Diamondback 360 ® PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The system is contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician.
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CONTACT: Cardiovascular Systems, Inc.
KEYWORD: UNITED STATES EUROPE NORTH AMERICA MINNESOTA GERMANY
INDUSTRY KEYWORD: HEALTH CARDIOLOGY MEDICAL DEVICES PROFESSIONAL SERVICES FINANCE
SOURCE: Cardiovascular Systems, Inc.
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PUB: 11/13/2018 04:05 PM/DISC: 11/13/2018 04:05 PM