Cordis Launches SELUTION SLR Drug-Eluting Balloon in Japan with Strong Three-Year Clinical Data
Key Insights
Cordis has launched the SELUTION SLR PTA Drug-Eluting Balloon in Japan, marking the first sirolimus-eluting balloon approved for peripheral artery disease (search) treatment in the country.
The SELUTION SFA Japan clinical trial demonstrated impressive three-year outcomes with 81.5% primary patency and 93.8% of patients remaining free from reintervention.
The device features Sustained Limus Release technology designed to provide controlled sirolimus delivery over 90 days to reduce restenosis (search) and restore vessel function.
Cordis has launched the SELUTION SLR PTA Drug-Eluting Balloon (DEB) in Japan, marking a significant milestone as the first sirolimus-eluting balloon approved for peripheral artery disease (search) treatment in the country. The launch is supported by robust three-year clinical data demonstrating sustained efficacy and safety in a complex patient population.
Strong Clinical Performance in Japanese Trial
The SELUTION SFA Japan clinical trial results show impressive durability with 81.5% primary patency and 93.8% of patients remaining free from reintervention through three years. These outcomes support the device's role as an important treatment option for patients with peripheral artery disease (search).
Dr. Yoshimitsu Soga, Co-Principal Investigator of the SELUTION SFA Japan clinical trial and Director of Cardiology at Kokura Memorial Hospital, expressed satisfaction with the availability of the device. "I am pleased to see SELUTION SLR DEB now available for use in clinical practice in Japan. 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."
Technology and Clinical Experience
The SELUTION SLR DEB is designed to deliver sirolimus in a controlled, sustained manner to reduce restenosis (search) and restore vessel function. The device features Sustained Limus Release (SLR) technology, which provides controlled and sustained drug release through 90 days, covering the restenosis cascade.
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 (search), Osaka Keisatsu Hospital, highlighted his early clinical experience. "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."
Expanding Clinical Evidence in Coronary Applications
Cordis will present additional clinical insights from the SELUTION SLR DEB program at Cardiovascular Research Technologies (CRT) 2026, March 7-10 in Washington, D.C. The presentations will include 12-month results from both the SELUTION4ISR and SELUTION DeNovo trials, along with new subset analyses examining how procedural experience influences treatment strategy.
According to George Adams, MD, Chief Medical Officer at Cordis, "These presentations build on SELUTION4ISR and SELUTION DeNovo results presented at TCT, where both trials met their primary endpoints versus current standard of care. Presentations at CRT provide additional insight into 12-month SELUTION outcomes and examine how procedural experience with drug-eluting balloon therapy influences clinical decision-making."
Global Availability and Company Commitment
The SELUTION SLR Drug-Eluting Balloon (search) is commercially available in more than 65 countries and remains investigational in the United States. The device represents Cordis's continued focus on expanding innovative treatment options for cardiovascular disease.
"At Cordis, we recognize the impact peripheral artery disease (search) can have on patients and their daily lives," said Dr. Adams. "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."