Cardiovascular Systems (CSI) has secured approval from the Japan’s Ministry of Health, Labor and Welfare (MHLW) to use Diamondback 360 Coronary Orbital Atherectomy System (OAS) with Classic Crown (Classic Crown) and ViperWire Advance Coronary Guidewire FlexTip (FlexTip).
Cardiovascular Systems stated that Classic Crown is a coronary atherectomy device in the US. It uses a 1.25mm eccentrically mounted diamond-coated crown, with a combination of centrifugal force and differential sanding to safely modify arterial calcium.
The device now has GlideAssist, which allows for tracking, easy removal and smooth repositioning of the device, particularly in challenging anatomies.
FlexTip is a new atherectomy guidewire with 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 chairman, president and CEO Scott Ward said: “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 approval from MHLW for the Diamondback 360 Coronary OAS Micro Crown in March 2017 and reimbursement approval last February.
In November 2016, CSI selected Medikit signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.
Cardiovascular Systems is a Minnesota-based medical device company focused on developing devices for treating vascular and coronary disease. The company’s OAS treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in few minutes.
The US Food and Drug Administration (FDA) had granted 510(k) clearance for the use of Diamondback Orbital Atherectomy System in peripheral arteries in August 2007.