Cardiovascular Systems Receives U.S., Japanese Approvals for Diamondback 360 Coronary Micro Crown

Cardiovascular Systems Inc.’s (CSI) Diamondback 360 Coronary OAS Micro Crown system has been approved in both the United States and Japan for coronary intervention treatment.

The U.S. Food and Drug Administration (FDA) gave its blessing to the Diamondback 360 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. In Japan, the device was approved by the country’s Ministry of Health, Labor and Welfare (MHLW) as a frontline treatment for de novo severely calcified lesions and to facilitate access to the arteries for percutaneous coronary interventions (PCI) thereafter.

“We are committed to continued advancement of CSI’s proven OAS technology focused on severe coronary arterial calcium, which is an underserved problem in vascular medicine,” said Scott Ward, chairman, president and CEO of CSI. “Patients with severely calcified coronary lesions are some of the most difficult to treat, leading to worse clinical and economic outcomes. The ORBIT II and COAST studies demonstrated that orbital atherectomy technology is safe and effective in treating patients with severely calcified lesions.”
 
The Diamondback 360 Coronary OAS Micro Crown retains the novel mechanism of action of the Diamondback 360 Coronary OAS Classic Crown. Both systems allow treatment of multiple vessel sizes with one device while providing continuous flow of blood during treatment, which is important for both acute and long-term success. The OAS Micro Crown is the only device incorporating a diamond-coated tip to immediately engage and pilot through tight, severely calcified lesions that would otherwise be difficult to access, while also treating up to 4mm vessels with the same device. The increased mass of the sanding crown allows for lower rotational speeds, while maintaining the same orbit diameter as the OAS Classic Crown.
 
“We are excited to receive this approval, which furthers our mission to provide primary tools for the treatment of calcified artery disease and facilitates our first international expansion,” Ward said. “Japan represents an attractive market opportunity as the world’s second-largest market for coronary interventions with over 280,000 PCIs per year, of which 10 percent-20 percent are estimated to be severely calcified. We look forward to working with Medikit, Co. Ltd., our exclusive distribution partner with a large sales force in Japan, to pursue this opportunity.”
 
Nobufumi Kurita, president of Medikit Co., added, “Heart disease is one of the leading causes of death in Japan. While the prevalence of severely calcified coronary disease is similar to levels in the U.S, it is more readily identified in Japan, given the frequent use of advanced imaging technologies during PCI treatment. We are excited to introduce CSI’s novel OAS Micro Crown to this large and underserved patient population. Our team of coronary sales specialists will initially focus on a limited number of top medical institutions, driving quality adoption in those accounts and preparing for a full commercial launch in calendar 2018.”
 
COAST was a Harmonization-by-Doing clinical study for the OAS Micro Crown conducted in both the United States and Japan under the regulations of both governments. COAST was led by U.S. National Principal Investigator Gregg W. Stone, M.D., of New York-Presbyterian Hospital/Columbia University Medical Center, New York, N.Y., and Japan National Principal Investigator Dr. Shigeru Saito of Shonan Kamakura General Hospital, Kamakura City, Japan.
 
CSI’s Diamondback 360 Coronary OAS Classic Crown and Micro Crown are the first and only atherectomy devices approved in the United States to specifically treat severely calcified coronary arteries. Since FDA approval of the OAS Classic Crown in October 2013, more than 25,000 devices have been used to treat patients with CAD. The OAS Micro Crown will supplement the existing OAS Classic Crown product line offering in the United States. A limited release of the OAS Micro Crown is expected to begin in the United States later this summer.
 
CAD is a life-threatening condition and a 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, severe arterial calcium is present in approximately 12 percent of patients undergoing a percutaneous coronary intervention. Severe 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.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes 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 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. To date, more than 290,000 of CSI’s devices have been sold to U.S. institutions.
 
Established in 1973 and based in Tokyo, Japan, Medikit Co. is a global medical technology company that is publicly-traded on the JASDAQ exchange. Medikit is a market leader in interventional products including vascular access devices such as hemodialysis catheters, intravenous catheters, sheaths and guiding catheters. Medikit products are sold in Japan, the United States and more than 30 other countries. The company has R&D and manufacturing capabilities in Japan and Vietnam with more than 1,300 consolidated employees.