Cardiovascular Systems Announces Commercial Launch in Japan

Cardiovascular Systems Inc., a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, has commercially treated the first patient in Japan with its Diamondback 360 Coronary OAS Micro Crown (Micro Crown).
 
Following CSI’s COAST trial, the device was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a frontline treatment for de novo severely calcified lesions and to facilitate access to the arteries for percutaneous coronary interventions (PCI) post procedure.
 
COAST was a Harmonization-By-Doing clinical study for the Micro Crown conducted in both the United States and Japan under the regulations of both governments. In Japan, COAST was led by the National Principal Investigator Dr. Shigeru Saito, of Shonan Kamakura General Hospital, Kamakura City, Japan.
 
Saito, who treated the first patient, said, “Patients with severely calcified coronary lesions are some of the most difficult to treat, leading to unfavorable clinical and economic outcomes. The commercialization of the Micro Crown in Japan provides physicians with a new technology to treat this unmet medical need.”
 
Orbital atherectomy has demonstrated clinical advantages compared to historical rotational atherectomy data, including lower rates of target lesion revascularization (TLR) and persistent slow flow/no reflow. CSI’s Micro Crown is the only atherectomy system designed to both pilot tight, calcific coronary lesions and treat larger vessels up to 4mm with a single device. The company’s ORBIT II and COAST clinical studies demonstrated that OAS is safe and effective in treating patients with de novo severely calcified coronary lesions.
 
Dr. Jan B. Pietzsch, president and CEO of health economics consultancy Wing Tech Inc. and director, Health Economics and Value, Stanford Byers Center for Biodesign, who studied the clinical and economic challenges of calcified lesion treatment, said, “In a post hoc economic subanalysis, orbital atherectomy was associated with a reduction in one-year reintervention costs when compared to historical rotational atherectomy data. This is due to the reduced need for repeat revascularization, lower cardiac mortality and fewer devices used per procedure.”
 
CSI received PMDA approval for the Micro Crown in March 2017 and reimbursement approval effective February 2018. Medikit Co., Ltd. is CSI’s exclusive distribution partner in Japan. With a controlled launch now underway, CSI expects to complete an initial Micro Crown stocking order during its third fiscal quarter and open approximately 15 accounts by the end of the fiscal year.
 
CSI Chairman, President and CEO Scott Ward said, “We are excited to bring orbital atherectomy technology to Japan. Ten to 20 percent of the 280,000 Japanese patients who undergo percutaneous coronary procedures each year have severely calcified coronary lesions. The introduction of Micro Crown gives physicians in Japan a cost-effective treatment option for this difficult-to-treat patient population.”
 
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 U.S. Food and Drug Administration (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, over 340,000 of CSI’s devices have been sold to leading institutions across the United States.
 
Established in 1973 and based in Tokyo, Medikit Co. Ltd. is a global medical technology company and 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 over 30 other countries. The company has R&D and manufacturing capabilities in Japan and Vietnam with more than 1,300 consolidated employees.