Cardiovascular Systems, Inc. announced 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). 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. 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.