Cordis Debuts First-of-its-Kind Artery Treatment in Japan

TOKYO, JAPAN – April 28, 2026 – Cordis, a veteran in cardiovascular technology, today launched a groundbreaking treatment for peripheral artery disease (PAD) in Japan, offering new hope to patients suffering from the debilitating circulatory condition. The device, known as the SELUTION SLR™ PTA Drug-Eluting Balloon (DEB), is the first of its kind to receive regulatory approval in the country, leveraging the drug sirolimus to combat a common complication of artery-opening procedures.

The introduction of this technology marks a significant milestone in a market previously dominated by other drug-delivery systems. For thousands of Japanese patients who experience pain, cramping, and reduced mobility from narrowed arteries in their legs, this launch represents a pivotal expansion of advanced, minimally invasive treatment options.

A New Era for PAD Intervention

Peripheral artery disease is caused by the buildup of plaque in arteries, most commonly in the legs, which restricts blood flow. While physicians have long used balloon angioplasty to widen these vessels, a frequent challenge is restenosis—the re-narrowing of the artery as scar tissue builds up after the procedure. Drug-eluting balloons were developed to address this by delivering medication directly to the vessel wall to inhibit this process.

The SELUTION SLR™ DEB distinguishes itself by being the first sirolimus-eluting balloon approved for PAD in Japan. Sirolimus is a well-established drug known for its ability to prevent cell proliferation. The balloon's proprietary technology is designed for a controlled, sustained release of the drug, aiming to restore vessel function and maintain its openness over the long term.

This approach provides a novel alternative in a market where paclitaxel-coated balloons have been the standard. Early clinical experiences in Japan have been promising. Dr. Osamu Iida, Director of the Department of Cardiology at Osaka International Medical & Science Center and a co-principal investigator for the device's key clinical trial, noted the device's immediate performance. "In my early clinical experience, I've observed strong post-procedural blood flow without evidence of downstream effects below the knee," he stated. "I look forward to seeing its broader adoption in real-world clinical practice."

Validated by Robust Clinical Data

The confidence of clinicians is bolstered by compelling long-term data from the SELUTION SFA Japan clinical trial, results of which were published in the prestigious journal JACC: Cardio Interventions. The study was pivotal in securing approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) under the medical device approval number 30700BZI00031000.

The trial enrolled 134 patients across 13 Japanese centers, a group representing a real-world challenge with a mean age of nearly 74 years and over 60% suffering from diabetes mellitus—a key risk factor for severe PAD. The lesions treated were also complex, with an average length of over 12 centimeters.

Despite these challenges, the results demonstrated remarkable durability. After three years, 81.5% of patients' treated arteries remained open, a measure known as primary patency. Even more impressively, 93.8% of patients remained free from the need for a repeat procedure on the treated lesion. This high rate of freedom from reintervention is a critical metric, as it translates directly to fewer hospital visits and a better quality of life for patients.

"I am pleased to see SELUTION SLR™ DEB now available for use in clinical practice in Japan," said Dr. Yoshimitsu Soga, Director of Cardiology at Kokura Memorial Hospital and the trial's other co-principal investigator. "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."

Strategic Entry into a Competitive Market

The launch is a calculated strategic move for Cordis, a company with a nearly 70-year history of cardiovascular firsts, including the first drug-eluting stent. Entering the sophisticated and high-value Japanese medical device market with a first-in-class product positions the company for significant growth. The Japanese market for paclitaxel-coated balloons alone is estimated to be worth over $100 million annually, indicating a substantial opportunity for a novel and effective alternative.

By securing PMDA approval, Cordis has navigated a rigorous regulatory pathway, signaling the strength of its clinical evidence and manufacturing quality. This approval opens the door to a new competitive front against established players in the vascular intervention space, such as Medtronic and Boston Scientific.

"At Cordis, we recognize the impact peripheral artery disease can have on patients and their daily lives," said Dr. George Adams, the company's Chief Medical Officer. "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."

Redefining Patient Outcomes and Quality of Life

Beyond market dynamics and corporate strategy, the ultimate significance of this launch lies in its potential impact on patients. PAD can severely diminish quality of life, progressing from pain while walking to constant pain at rest and, in the most severe cases, leading to non-healing ulcers and amputation.

The promise of a treatment that offers durable, long-term results is profound. A procedure that effectively keeps arteries open for years, as suggested by the SELUTION SFA Japan trial data, means patients can potentially avoid the physical, emotional, and financial burden of repeated interventions. The 93.8% freedom from reintervention at three years is not just a statistic; it represents thousands of days free from follow-up procedures and hospital stays.

As this new technology becomes more widely available, it offers physicians in Japan a powerful tool to manage a complex and growing patient population. For individuals struggling with the daily realities of PAD, the arrival of the SELUTION SLR™ DEB provides a new measure of hope for sustained mobility and a return to a more active life.