Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), announced that the first seven patients in Japan have been enrolled in its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place in the United States and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI's new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease (CAD). Dr. Shigeru Saito, Director of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, performed the procedures on October 27. The 1.25 mm micro crown is CSI's second-generation system designed to facilitate stent delivery in patients with severely calcified lesions who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting. The micro crown OAS is designed to improve the tracking and piloting of the OAS driveshaft and the ability of the crown to reach the lesion while operating at lower rotational speeds. "We're excited to be in CSI's pivotal COAST study," said Dr. Saito. "Today, I used the company's new micro crown OAS to successfully modify calcified coronary lesions in seven patients. Prepping the vessels with CSI's technology enabled stent delivery and expansion in these challenging patient cases." Building on CSI's ORBIT II study, the first study designed to enroll patients with severely calcified lesions who are typically excluded from all major trials but commonly seen in the real-world, COAST is a prospective, single-arm, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI's new micro crown OAS in treating these difficult lesions. Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Enrollment in the United States began in June 2014. Dr. Gregg Stone, Director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center, New York, and Dr. Shigeru Saito are the study's principal co-investigators.
"COAST highlights our continued commitment to improving CSI's leading technology to modify calcified lesions throughout the body," said David L. Martin, CSI president and chief executive officer. "Enrollment of the first patients in Japan is a key milestone and allows us to begin collecting the valuable data to support approval of our micro crown OAS in the world's two largest coronary markets."About Coronary Artery Disease (CAD)CAD is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE). 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 Systems 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. To date, over 157,000 of CSI's devices have been sold to leading institutions across the United States. For more information, visit the company's website at www.csi360.com. Safe HarborCertain 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 (i) the COAST trial; (ii) international expansion; and (iii) approval of the micro crown OAS in the United States and Japan, are forward-looking statements. These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the effectiveness of the micro crown OAS; actual clinical trial and study results; government clearances and approvals; 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. Micro Crown OASCSI has commenced its COAST Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its new micro crown orbital technology in treating coronary arteries. This new system is limited by federal law to investigational use and is currently not commercially available in the United States or Japan.