ST. PAUL, Minn.--(BUSINESS WIRE)--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 Europe has been treated with its Stealth 360® Peripheral Orbital Atherectomy System (OAS) 1.25mm Micro Crown with GlideAssist® (1.25 Micro Crown).
The 1.25 Micro Crown is designed with flexibility for tortuous vessels and tight bends below the knee. The GlideAssist feature enables the crown to spin at a slow speed of 5K rpm, facilitating tracking and smoother movement to access diffuse, calcified lesions below the knee.
Dr. Michael Lichtenberg, Chief Physician, Clinic for Angiology, Hochsauerland Hospital, Arnsberg, Germany, successfully treated the first peripheral patient with the 1.25 Micro Crown.
Dr. Lichtenberg said, “CSI’s new Stealth OAS 1.25 Micro Crown with GlideAssist is a welcome addition to my toolbox for treating challenging critical limb ischemia, or CLI, cases. In particular, the device’s dual mechanism of action of differential sanding and pulsatile forces will be instrumental in the treatment of the challenging calcified lesions I often see in lesions below the knee.”
Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, “With our distribution partner, OrbusNeich®, we are excited to introduce the 1.25 Micro Crown in Germany. One million German patients suffer from CLI, a severe condition that can result in severe pain, tissue damage and loss of limbs. The 1.25 Micro Crown provides physicians with a minimally invasive therapy to access and effectively treat this condition by modifying calcified lesions below the knee and restoring blood flow to the foot.”
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 orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com.
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.
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 the benefits of the 1.25 Micro Crown; and the opportunity relating to German, European and other international sales, 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 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.
EU Indication for Use: The Stealth 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Contraindications: The OAS are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present.
Warnings/Precautions: 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.
See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
The Stealth 360® PAD System and Diamondback 360® PAD System received FDA 510(k) clearance. The Stealth 360® PAD System is CE Marked.