“As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary in-stent restenosis.” Cordis President of Americas Matt Muscari said in the announcement. “This innovative device will enable physicians to address one of the most complex coronary clinical challenges.”
Drug-eluting stents are currently the standard of care for percutaneous coronary interventions (PCIs). Cordis’ drug-eluting balloon was designed to deliver immunosuppressant therapy with sirolimus for up to 90 days without leaving a permanent implanted stent.
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Selution SLR DEB uses biodegradable polymer microreservoir technology that mixes the polymer with sirolimus to control drug release, acting as tiny drug delivery systems. These microreservoirs are coated with a phospholipid blend that “facilitates drug uptake and retention in the tissue with minimal drug loss during the procedure,” the company says.
“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” Cordis Chief Medical Officer Dr. George Adams said. “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.”
After receiving FDA investigational device exemption in 2022, Cordis conducted a randomized, non-inferiority trial to evaluate Selution SLR DEB against standard-of-care drug-eluting stents in patients with coronary in-stent restenosis.
At the one-year point of the study, Cordis’ drug-eluting balloon technology proved noninferior to the systematic use of the drug-eluting stents featured in the study for the primary endpoint of target vessel failure in the target population, the study showed.
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Selution SLR DEB also proved to be an effective, noninferior alternative to the standard of care in the study’s target population in a secondary study. Cordis acquired the DEB technology from MedAlliance for $1.135 billion in 2023.
After earning FDA approval to treat in-stent restenosis, Cordis is already looking to expand Selution SLR DEB’s indications for use. The company has completed enrollment for its randomized study evaluating Selution SLR DEB against drug-eluting stents to treat de novo lesions in small coronary vessels. Cordis plans to use the study results to support a future FDA premarket approval submission.
