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Japanese Postmarket Surveillance Data for Zilver PTX Presented at EuroPCR 2014

May 29, 2014—At last week’s EuroPCR 2014 meeting, Hiroyoshi Yokoi, MD, of Fukuoka Sanno Hospital presented 1-year data from from a postmarket surveillance study of 907 Japanese patients who were treated using the Zilver PTX peripheral drug-eluting stent (Cook Medical) in the superficial femoral artery.

Cook's Zilver PTX Postmarket Study in Japan Shows Positive Outcomes at 24 Months

November 3, 2015—The 24-month results from the Zilver PTX Postmarket Study, conducted in Japan, were presented by Hiroyoshi Yokoi, MD, during the second of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting.

Japanese Postmarket Study Data Published for Cook Medical's Zilver PTX Stent to Treat SFA Disease

February 3, 2016—In the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Hiroyoshi Yokoi, MD, et al published the 12-month results from the Japanese postmarket surveillance study of the Zilver PTX paclitaxel-eluting stent (Cook Medical) for treating femoropopliteal artery disease (2016;9:271–277).

Medtronic's In.Pact Admiral DCB Approved in Japan

September 8, 2017—Medtronic announced that its In.Pact Admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the superficial femoral arteries (SFAs) and popliteal arteries.

CSI’s Diamondback 360 OAS Evaluated in KAIZEN Study to Secure Regulatory Approval in Japan

January 11, 2023—Cardiovascular Systems, Inc. (CSI) announced the initiation of the KAIZEN clinical study of the company’s Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment of calcified plaque in patients with peripheral artery disease.

Japan Approves PROMISE II Trial to Evaluate LimFlow’s pDVA System for CLTI

March 23, 2021—LimFlow SA announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company’s Clinical Trial Notification for the Japanese cohort of the ongoing pivotal PROMISE II trial of the LimFlow percutaneous deep vein arterialization (pDVA) system for the treatment of chronic limb-threatening ischemia (CLTI).

Cook Medical's Zilver PTX Data Show Continued Patency at 5 Years

November 4, 2014—Cook Medical announced that 5-year results from the clinical trial of the Zilver PTX paclitaxel-eluting stent for treating peripheral arterial disease (PAD) confirmed long-term patency for patients treated with the device.