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

The FDA approved the Selution sustained limus release (SLR) drug-eluting balloon (DEB or DCB) to treat coronary in-stent restenosis (ISR), Cordis announced Monday.

This makes Selution SLR the only sirolimus-based DEB available to treat an obstruction or narrowing of a stented vessel in patients with coronary artery disease. Selution SLR was made for sustained sirolimus release for up to 90 days without leaving behind an additional metal layer during percutaneous coronary intervention (PCI).

“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” said George Adams, MD, Chief Medical Officer of Cordis, in a company 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. We are proud to help expand treatment choices in ways that can make a real difference in patient care.”

The FDA’s approval was based on the SELUTION4ISR trial, in which the Selution ISR DEB met criteria for noninferiority against standard of care, namely drug-eluting stents (DES) and angioplasty, in an ISR cohort: target lesion failure came out to 15.2% versus 13.5% between randomized groups, respectively, at 1 year in the 418-person trial.

Eligible PCI candidates had to present with a target lesion within prior bare metal stenting or DES and no more than 5 mm from the proximal or distal edge. Investigators excluded people with ST-segment elevation myocardial infarction and those with more than two layers of prior stenting, >30% diameter stenosis, or type C lesions after pretreatment.

Selution was notable for having held up to DES as a modern comparator in SELUTION4ISR.

While Boston Scientific’s paclitaxel-based Agent DCB was the first in this class of technology to get FDA approval 2 years ago, its pivotal trial had the caveat of having relied on plain balloon angioplasty alone as the control. The comparative safety and efficacy of the Selution SLR DEB against the Agent DCB is unknown. How DCBs fare in the long-term management of ISR also remains to be seen.

“We welcome innovation in the U.S. coronary drug-coated balloon market for the treatment of in-stent restenosis, a space pioneered by the Agent DCB, which remains the only FDA-approved paclitaxel-coated coronary balloon,” said Janar Sathananthan, MD, president of interventional cardiology at Boston Scientific. Outside ISR, the Agent DCB is being evaluated for de novo small vessel or bifurcation coronary artery disease in the STANCE trial.

The Selution SLR also showed noninferior efficacy for de novo lesions in coronary arteries between 2 and 5 mm in diameter in the SELUTION De Novo trial.