Cordis Announces Positive Results from Two Major Clinical Studies
By Azmed Devices Editorial Team
Cordis announced positive 3-year data from the SELUTION SFA Japan trial and 12-month data from the SUCCESS PTA global registry, confirming the durable efficacy of the SELUTION SLR drug-eluting balloon in treating complex peripheral artery disease.
According to Cordis, the company has released new clinical data from two major studies evaluating the SELUTION SLR Drug-Eluting Balloon for the treatment of peripheral artery disease. Findings from the SELUTION SFA Japan trial were presented at the Japan Endovascular Treatment Conference, while the 12-month results from the SUCCESS PTA Study were showcased at the Charing Cross Symposium in London. The data indicates that the technology provides sustained efficacy and safety across diverse, real-world patient populations, achieving outcomes that compare favorably to established benchmarks.
The SELUTION SFA Japan trial followed 134 complex patients over three years, where the device achieved 81.5% primary patency and 93.8% freedom from Clinically Driven Target Lesion Revascularization. Cordis notes that this is the first sirolimus drug-eluting technology to demonstrate such long-term patency rates exceeding 80% with core lab adjudication. Principal investigator Dr. Iida described these results as an evolution in treatment strategies, highlighting the durability of the device in comparison to traditional paclitaxel-coated balloons.
The global SUCCESS PTA Study evaluated 723 patients across Europe, Asia, and South America to assess real-world performance. According to Cordis, the 12-month primary endpoint of freedom from Clinically Driven Target Lesion Revascularization was 91.1% in the total population, with consistent performance reported in both claudicants at 91.3% and those with chronic limb-threatening ischemia at 90.3%. Furthermore, 88.1% of patients demonstrated an improvement of at least one Rutherford category, supporting the clinical benefit of the sirolimus MicroReservoir technology.
Source
This article summarizes an official Cordis announcement. Read the original at https://cordis.com/emea/news/cordis-announces-positive-results-from-two-major-clinical-studies.. Product availability in Azerbaijan is subject to local registration; contact Azmed Devices for current status.
