The Miami Lakes, Florida-based company presented 12-month results from the SUCCESS PTA study at the Charing Cross Symposium in London. It then shared SELUTION SFA Japan three-year results today at the Japan Endovascular Treatment Conference in Osaka.
According to Cordis, the studies confirmed the sustained efficacy and safety of Selution SLR in treating complex peripheral artery disease (PAD). It proved effective and safe across diverse, real-world patient populations, according to a news release. Cordis said the balloon favorably matched best-in-class benchmarks from paclitaxel-eluting technologies, too.
Cordis acquired the DEB technology from MedAlliance for $1.135 billion in 2023. It shared similarly positive findings nearly a year ago as well.
“At Cordis, our focus is always on advancing therapies that offer meaningful, lasting impact for patients—and these results do exactly that,” said Dr. George Adams, chief medical officer at Cordis. “The Selution SLR studies showcase drug elution, done better – sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations. This is the kind of innovation that truly elevates patient care.”
More about the Cordis Selution SLR study results
Cordis’ SELUTION SFA Japan trial took place in a single arm across 13 sites in Japan. It evaluated Selution SLR in 134 complex patients.
At three years, the balloon demonstrated primary patency of 81.5% and freedom from clinically driven target lesion revascularization (CD-TLR) of 93.8%. Results pit Selution SLR as the only drug-eluting technology with core-lab adjudicated three-year patency over 80%, Cordis said.
“Selution SLR DEB represents the next evolution in leave-nothing-behind treatment strategies. These 3-year outcomes demonstrate unprecedented durability in complex patients with primary patency greater than 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period,” said Dr. Iida of the Cardiovascular Division at Osaka Police Hospital, Japan and study principal investigator.
Cordis’ SUCCESS PTA study, a prospective, observational global registry, looked at the balloon in 723 patients. It took place across 27 sites in Europe, Asia and South America. The company said it reflects real-world practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI).
Investigators reported a consistently high primary endpoint of freedom from CD-TLR at 12 months. It came in at 91.1% in the overall population, 91.3% in claudicants and 90.3% in CLTI patients. All patient cohorts saw clinical improvements, 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,” said Dr. Michael Lichtenberg, chief of interventional angiology at Klinikum Hochsauerland, Germany, chief medical officer and director of Vascular Center Clinic, Germany, and study principal investigator. “These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients.”
