FDA approves first sirolimus drug-eluting balloon for in-stent restenosis
The U.S. Food and Drug Administration (FDA) has approved the Cordis Selution SLR (Sustained Limus Release) drug-eluting balloon (DEB) for the treatment of coronary in-stent restenosis (ISR). This is the first sirolimus DEB cleared in the U.S.
The FDA previously designated this device as a breeakthrough device because of its sustained limus release, allowing the anti-proliferative drug to continue to prevent the growth of scar tissue inside a stent over a longer period of time to prevent further ISR.
“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 ISR," Matt Muscari, president of the Americas at Cordis, said in a statement. "This innovative device will enable physicians to address one of the most complex coronary clinical challenges."
“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” added George Adams, MD, chief medical officer of Cordis. “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 new FDA approval was based on results from the SELUTION4ISR trial. The prospective, multicenter, randomized, single-blind, controlled non-inferiority study evaluated the device compared to the standard of care of using drug-eluting stents (DES) or balloon angioplasty in patients with coronary ISR. It included more than 400 patients across 48 sites in the U.S., Canada, Brazil and Europe. At one year, the study met its primary endpoint of non-inferiority in the target population.
Target lesion failure occurred in 16.2% of the DEB group and 14.5% of the control group, which was within the noninferiority parameters set for the trial. The DEB was noninferior to a usual care control strategy for using repeat DES, but not noninferior to DES for single-layer ISR for target lesion failure at 12 months.
Paclitaxel-coated balloons have been shown in clinical trials to be better than plain balloon angioplasty in treating ISR, but inferior to repeat DES use. Sirolimus offers a broader therapeutic window and was seen as being a better drug to treat ISR, but there were development delays due to technical challenges in drug delivery and tissue uptake that needed to be worked out, resulting in the Selution SLR device.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]