The FDA gave the green light to a first and only sirolimus drug-eluting balloon designed by Cordis to treat coronary in-stent restenosis.
The regulatory approval represents a significant leap for the treatment of what is considered a complex challenge in interventional cardiology, the company said in a Sept. 21 press release.
Dubbed the Selution SLR DEB, the device delivers sustained sirolimus therapy without leaving a permanent implant in the patient. Sirolimus is an immunosuppressive agent that is typically used to prevent the rejection of a transplanted organ.
The device was approved under the FDA’s breakthrough device designation that accelerates development, assessment and review for products that show effective treatment or diagnosis of life-threatening conditions.
“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” George Adams, M.D., Cordis’ chief medical officer, said in a statement. “The availability of Selution SLR DEB in the United States is meaningful for interventional cardiologists because it provides an effective and highly deliverable sirolimus-based treatment option while helping minimize the need for another stent.
An estimated 1 million percutaneous coronary interventions are performed in the U.S. each year, and about 10% addressing ISR, the company said. The approval was supported by a study of more that 400 patients in the U.S., Canada, Brazil and Europe that evaluated the device against standard care that includes 80% drug-eluded stents.
Cordis also announced it completed enrollment in a 960-patient study to evaluate the Selution SLR DEN device against drug-eluting stents that treat de novo lesions in small coronary vessels as part of a future FDA pre-market approval application.
The company began beefing up its drug-eluting balloon portfolio when it acquired Swiss manufacturer MedAlliance in 2022 in a deal that was valued at $1.1 billion over a seven-year period and included the Selution device.