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 patient in Hong Kong has been treated with its Diamondback 360 Coronary Orbital Atherectomy System (OAS). This procedure marks the first international coronary procedure taking place as a result of the companys distribution agreement with OrbusNeich.
Dr. Michael Kang-Yin Lee, MBBS, FACC, FRCP, Director of Cardiac Catheterization Laboratory at the Division of Cardiology, Department of Medicine, Queen Elizabeth Hospital, Hong Kong, said, Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap of the conventional devices when treating calcified coronary arteries.
Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, We are thrilled to begin introducing our proven coronary atherectomy technology to physicians worldwide. As our international distribution partner, OrbusNeich, identifies new markets, we are prepared to provide best-in-class training to physicians committed to improving patient outcomes within this underserved patient population.
Teddy Chien, Chairman Emeritus and Founder of OrbusNeich, added, I was very pleased to have witnessed the first ever Coronary Orbital Atherectomy procedure performed in Hong Kong. CSIs device supports our key business focus of providing solutions for all complex vascular interventions. We look forward to continuing global distribution of this clinically proven technology to our customers.
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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.
In January 2018, CSI announced that it was the exclusive U.S. distributor for OrbusNeich balloon products. Ultimately, CSI will offer a full line of semi-compliant, non-compliant and specialty balloons for both coronary and peripheral vascular procedures. OrbusNeich PCI balloons include the Sapphire II Pro, the first and only 1.0mm coronary balloon available in the United States.
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 companys 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 CSIs 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 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 CSIs 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 CSIs 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.