Cordis Selution SLR DEB Evaluated in Two Studies of Complex PAD Patients

April 24, 2025—Cordis announced new data from the SUCCESS PTA and SELUTION SFA Japan peripheral studies evaluating the company’s Selution SLR (sustained limus release) drug-eluting balloon (DEB).

According to Cordis, the studies confirm the sustained efficacy and safety of the Selution SLR in treating complex peripheral artery disease (PAD) across diverse, real-world patient populations, favorably matching best-in-class benchmarks from paclitaxel-eluting technologies.

The SUCCESS PTA study’s 12-month results were delivered at the Charing Cross International Symposium 2025 held April 23-25 in London, United Kingdom.

The SELUTION SFA Japan trial’s 3-year results were presented at JET2025, the Japan Endovascular Treatment conference held on April 25-27 in Osaka, Japan.

Cordis stated that SUCCESS PTA is a prospective, observational global registry evaluating the Selution SLR DEB in 723 patients across 27 sites in Europe, Asia, and South America. The study population reflects real-world practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI), noted the company.

The study’s Principal Investigator is Michael Lichtenberg, MD, Chief of Interventional Angiology at Klinikum Hochsauerland and Chief Medical Officer and Director of the Vascular Center Clinic Arnsberg in Germany.

The company reported that the primary endpoint—freedom from clinically driven target-lesion revascularization (CD-TLR) at 12 months—was 91.1% in the overall population, 91.3% in claudicants, and 90.3% in CLTI patients. Additionally, clinical improvements were seen across the patient cohorts, with 88.1% of patients improving by at least one Rutherford category.

“Leveraging Selution SLR DEB with its unique sirolimus microreservoir technology delivers unequivocal clinical benefits in complex patient cohorts,” commented Dr. Lichtenberg in the Cordis press release. “These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients.”

The prospective, single-arm SELUTION SFA Japan trial evaluated the performance of the Selution SLR DEB in 134 complex patients enrolled at 13 sites across Japan.

Cordis reported that the SELUTION SFA Japan trial’s 3-year core lab–adjudicated data demonstrated primary patency of 81.5% and freedom from CD-TLR of 93.8%.

The study’s Principal Investigator is Osamu Iida, MD, with the Cardiovascular Division at Osaka Police Hospital in Osaka, Japan.

“Selution SLR DEB represents the next evolution in leave-nothing-behind treatment strategies,” commented Dr. Iida in the company’s press release. “These 3-year outcomes demonstrate unprecedented durability in complex patients, with primary patency > 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period.”