January 2, 2019
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) announced today that 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). CSII is a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease.
Classic Crown is the market-leading coronary atherectomy device in the United States. Classic Crown utilizes a 1.25mm 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.”
Scott Ward, Chairman, President and Chief Executive Officer of CSI, 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.”
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.