FDA Approves Selution SLR Drug-Eluting Balloon for Coronary In-Stent Restenosis

The US Food and Drug Administration has approved the Selution SLR sirolimus-eluting balloon for the treatment of coronary in-stent restenosis (ISR), bringing a second drug-coated balloon (DCB) option to US operators, device maker Cordis announced Monday.

The approval is based on the results of the SELUTION4ISR trial, which showed that use of the device was noninferior to standard of care—mostly drug-eluting stents but 20% plain old balloon angioplasty—for target lesion failure at 1 year.

Selution SLR is the first sirolimus-eluting balloon, but the second DCB of any type, approved for the treatment of coronary ISR. The Agent paclitaxel-coated balloon (Boston Scientific) gained FDA approval for that indication in March 2024.

In announcing the ISR news, Cordis also said that it had completed enrollment in the 960-patient SELUTION4DeNovo investigational device exemption (IDE) trial, which is evaluating use of the Selution SLR device for the treatment of de novo lesions in small coronary vessels. Previously, the SELUTION DeNovo trial, conducted in 12 countries in Europe and Asia, showed that a strategy involving use of the Selution SLR balloon plus provisional DES was noninferior to a DES-based strategy in this population.

The Selution SLR device is now available in more than 65 countries and has been used to treat more than 250,000 patients, Cordis said.