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Cardiovascular Systems, Inc. Receives Approval for the Diamondback 360® Coronary Orbital Atherectomy System with Classic Crown and New ViperWire Advance® FlexTip Guidewire in Japan

2019年01月02日 PM09:00
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ST. PAUL, Minn.

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, 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).

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.

About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative 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. 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 Ministry of Health, Labor and Welfare (MHLW) approval the Diamondback 360® Coronary OAS Micro Crown in March 2017 and 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.

About Medikit Co., Ltd.
Established in 1973 and based in Tokyo, Medikit Co., Ltd. is a global medical technology company and is publicly-traded on the JASDAQ exchange (JASDAQ: 7749). Medikit’s mission is to deliver the highest standards of excellence in operating as a health care company whose products and services help to enhance healthy lives by minimizing unnecessary suffering and death from disease. 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. For more information, visit the company’s website at www.medikit.co.jp.

Safe Harbor
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding the commercial launch of the Diamondback 360® Coronary OAS with Classic Crown and ViperWire Advance® Coronary Guidewire FlexTip in Japan and the opportunity in Japan, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the reluctance of physicians to accept new products; the effectiveness of the Diamondback 360 Coronary OAS with Classic Crown and ViperWire Advance® Coronary Guidewire FlexTip; the impact of competitive products and pricing; approval of products for reimbursement and the level of reimbursement; general economic conditions; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

Diamondback 360® Coronary Orbital Atherectomy Systems

Indications (United States): The Diamondback 360 Coronary Orbital Atherectomy Systems (OAS) are percutaneous orbital atherectomy systems indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS are contraindicated when the ViperWire® guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS are contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions; A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing Diamondback 360® Coronary OAS procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190102005091/en/

CONTACT

Cardiovascular Systems, Inc.
Jack Nielsen
(651) 202-4919
j.nielsen@csi360.com

Padilla:
Matt Sullivan
(612) 455-1709
matt.sullivan@padillaco.com

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