Dive Brief:
- Cordis said Monday the Food and Drug Administration has approved its drug-eluting balloon for the treatment of coronary in-stent restenosis.
- The device, Selution SLR, consists of an angioplasty balloon catheter coated with the drug sirolimus.
- Selution SLR is the first sirolimus balloon approved in the U.S., Cordis said. Boston Scientific won FDA approval for a paclitaxel-coated balloon in 2024, and several sirolimus devices are cleared for use in Europe.
Dive Insight:
Newer-generation stents have reduced, but not eliminated, the risk that the stented coronary artery lesion will narrow, a condition called in-stent restenosis, or ISR. U.S. guidelines recognize repeat stenting as the most effective treatment for preventing recurrent ISR. However, layering additional stents raises the risk of cardiovascular adverse events.
Boston Scientific brought its paclitaxel-coated device, Agent, to market after comparing the product with an uncoated balloon. Cordis’ Selution SLR launch is supported by clinical data showing the product is noninferior to a usual care control strategy, including 80% repeat drug-eluting stents.
Target lesion failure rates in all randomized patients were 15.2% for Selution SLR and 13.5% for the standard of care, meeting the primary noninferiority endpoint. However, the trial missed a secondary endpoint that assessed target lesion failure rates in patients with single-layer ISR. In that subgroup, the failure rates for Selution SLR and the standard of care were 14.2% and 6.5%, respectively.
Cordis has given U.S. physicians immediate access to Selution SLR. The launch provides an alternative to uncoated balloons and Boston Scientific’s paclitaxel-coated device. Boston Scientific named Agent as a driver of growth at its cardiovascular business in the first half of the year.
Johnson & Johnson sold Cordis in 2015 to Cardinal Health, which in turn sold the vascular technology company to the private equity firm Hellman & Friedman in 2021. Cordis, which received the first FDA approval of a sirolimus-eluting coronary stent in 2003, led efforts to use the drug with balloons in 2023 by acquiring MedAlliance.
MedAlliance had a CE mark for Selution SLR. The CE mark positioned Cordis to compete with Concept Medical’s Magic Touch and B. Braun’s SeQuent SCB for the European market. In parallel, Cordis worked to bring Selution SLR to the U.S. market.
