Cardiovascular Systems Receives Japanese Approval for Diamondback 360 Coronary System

Cardiovascular Systems Inc. (CSI) said Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the Diamondback 360 Coronary Orbital Atherectomy System (OAS) with Classic Crown (Classic Crown) and ViperWire Advance Coronary Guidewire FlexTip (FlexTip).
 
Classic Crown is the coronary atherectomy device in the United States. Classic Crown utilizes a 1.25 mm eccentrically mounted diamond-coated crown and a patented combination of centrifugal force and differential sanding to safely modify arterial calcium. This device now features GlideAssist, which allows for tracking, easier removal and smoother repositioning of the device— particularly in challenging anatomies.
 
FlexTip is a unique new atherectomy guidewire with a nitinol core and shapeable stainless-steel tip for increased flexibility and kink-resistance, improved navigation, and reduced guidewire bias in complex coronary vessels. Classic Crown can also be used with ViperWire Advance Coronary Guidewire FlexTip.
 
Dr. Shigero Saito, of Shonan Kamakura General Hospital, Kamakura City, Japan, and national principal investigator of CSI’s COAST trial who treated the first patient with both of the newly approved products, said, “Using the new ViperWire Advance FlexTip combined with the GlideAssist feature on Classic Crown allowed me to easily track the OAS device through tortuous coronary vessels and effectively modify a calcified lesion facilitating stent deployment.”

CSI received MHLW approval for the Diamondback 360 Coronary OAS Micro Crown in March 2017 and reimbursement approval in February 2018. In November 2016, CSI announced that Medikit, Co. Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.
 
CSI Chairman, President and CEO Scott Ward concluded, “We are excited to introduce the Classic Crown and FlexTip in Japan—the first market with an opportunity to use these two products together. Ten to 20 percent of the 280,000 Japanese patients who undergo percutaneous coronary interventions, or PCIs, each year have severely calcified coronary lesions. Multiple studies have shown that calcium is associated with poor PCI outcomes. Orbital atherectomy modifies calcific plaque to improve PCI results. Physicians in Japan may now consider our Classic Crown or Micro Crown to provide durable and cost-effective results for this large and underserved patient population.”
 
Cardiovascular Systems Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing solutions for treating vascular and coronary disease. The company’s OAS 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 company received approval from Japan’s MHLW approval the Diamondback 360 Coronary OAS with Classic Crown and ViperWire Advance Coronary Guidewire FlexTip in December 2018. The Stealth 360 Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over 400,000 of CSI’s OAS devices have been sold to leading institutions worldwide.
 
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.