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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 Diamondback 360® Coronary Orbital Atherectomy System (OAS).
Professor Nicolas Van Mieghem, Director of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands, who successfully treated the first European patient, said, "Patients with calcific coronary artery disease have poor clinical results. Diamondback 360® Coronary OAS streamlines treatment with a unique mechanism to successfully modify severe calcium and optimize stent performance. I’m confident European physicians will like this fascinating technology to help treat their patients with calcific coronary artery disease."
Orbital atherectomy has demonstrated clinical advantages compared to historical rotational atherectomy data, including lower rates of target lesion revascularization and persistent slow flow/no reflow. CSI’s ORBIT II and COAST clinical studies demonstrated that OAS is safe and effective in treating patients with de novo severely calcified coronary lesions. Two real-world studies with approximately 1000 patients have reinforced Diamondback’s safety, high procedural success and long term clinical success.
CSI received CE Mark for the Diamondback 360® Coronary OAS in January 2021. Diamondback is FDA approved and has been sold in the United States since 2013.
Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, "We are excited to announce the first commercial use of the Diamondback 360® Coronary OAS in Europe. The introduction of this device gives physicians in Europe an effective treatment option for this difficult-to-treat patient population. We are prepared to launch the product leveraging streaming platforms to train and support physicians and their cath lab teams remotely until travel may resume."
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 and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com and connect on Twitter @csi360.
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 commercial launch of the Diamondback 360® Coronary OAS in Europe (including the timing, scope and methods thereof), and the benefits of this product, 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, the reluctance of physicians, hospitals and other organizations to accept new products; the effectiveness of these products; the efforts of us and our distribution partners in launching this product; the impact of competitive products and pricing; approval of products for reimbursement and the level of reimbursement; general economic conditions; international trade developments; the ongoing COVID-19 pandemic and the impact and scope thereof on CSI, our distribution partners, the supply chain, and physicians and facilities in Europe, including government actions related to the COVID-19 outbreak, material delays and cancellations of procedures, delayed spending by healthcare providers, and distributor and supply chain disruptions; 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.
U.S. Diamondback 360® Coronary Orbital Atherectomy System
Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The OAS is contraindicated when the ViperWire® guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.
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 Diamondback 360® Coronary OAS is FDA PMA approved.
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Cardiovascular Systems, Inc.