OEM News

Cordis Introduces New PTA Drug-Eluting Balloon in Japan

SELUTION SLR is the first sirolimus-eluting balloon approved in Japan for peripheral artery disease treatment.

By: Michael Barbella

Managing Editor

Graphic: Business Wire.

Cordis has launched its SELUTION SLR PTA Drug-Eluting Balloon (DEB)1 in Japan. The device is engineered to deliver sirolimus in a controlled, sustained manner to reduce restenosis and restore vessel function.

“At Cordis, we recognize the impact peripheral artery disease can have on patients and their daily lives,” Cordis Chief Medical Officer George Adams, M.D., stated. “The launch of SELUTION SLR DEB in Japan reflects our focus on expanding innovative treatment options that physicians may consider based on individual patient needs. We look forward to continuing to work with the medical community in Japan to support patient care.”

The SELUTION SFA Japan clinical trial results demonstrate durable clinical outcomes in a complex patient population, including 81.5% primary patency and 93.8% of patients remaining free from reintervention through three years.2 As the first sirolimus-eluting balloon approved in Japan for treating peripheral artery disease, SELUTION SLR DEB provides an additional option for physicians managing patients in real-world clinical practice.

“I am pleased to see SELUTION SLR DEB now available for use in clinical practice in Japan,” said Dr. Yoshimitsu Soga, co-principal investigator of the SELUTION SFA Japan clinical trial and director of Cardiology at Kokura Memorial Hospital. “The three-year results from the SELUTION SFA Japan clinical trial demonstrate sustained efficacy and safety, supporting its role as an important treatment option for patients.”

“SELUTION SLR DEB is a valuable addition to the treatment options for peripheral vascular disease. In my early clinical experience, I’ve observed strong post-procedural blood flow without evidence of downstream effects below the knee. I look forward to seeing its broader adoption in real-world clinical practice,” added Dr. Osamu Iida, co-principal investigator of the SELUTION SFA Japan clinical trial and director of the Department of Cardiology at Osaka International Medical & Science Center, Osaka Keisatsu Hospital.

From the first guidewire to the first drug-eluting stent, Cordis has been at the heart of cardiovascular innovation for nearly 70 years. Cordis currently drives transformation through internal development, Cordis-X partnerships, and strategic acquisitions—powered by a global footprint and operational expertise. With a focus on better clinical outcomes, customer-centered service, and impactful education, Cordis pursues its mission to transform cardiovascular care.

References
1 Brand name: SELUTION SLR PTA drug-eluting balloon catheter
Medical device approval number: 30700BZI00031000
2 Soga, Y. et al. 3-Year Results Following Femoropopliteal Lesion Treatment With a Novel Sirolimus-Eluting Balloon. JACC: Cardio Interv 2025. 18(21):2629-2637.

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