The FDA has approved Cordis' SELUTION SLR sirolimus drug‑eluting balloon for coronary in‑stent restenosis, offering a non‑implant option to deliver sustained antiproliferative therapy. Approval follows Breakthrough Device designation and data from the SELUTION4ISR trial, which enrolled 400+ patients across 48 sites and met its primary non‑inferiority endpoint at 12 months (TLF 15.2% vs 13.5%). Cordis cites clinical experience in over 5,000 patients and has completed enrollment in a 960‑patient SELUTION4DeNovo IDE trial comparing the DEB with DES for small de novo lesions.
FDA Clears Cordis SELUTION SLR — First Sirolimus Drug‑Eluting Balloon Approved For Coronary In‑Stent Restenosis
The approval gives US physicians immediate access to the SELUTION SLR DEB
The US Food and Drug Administration (FDA) has approved Cordis' SELUTION SLR (sustained limus release) sirolimus drug‑eluting balloon (DEB) for the treatment of coronary in‑stent restenosis (ISR). The device delivers sustained sirolimus therapy to the vessel wall without leaving a permanent implant, offering an alternative to repeat stenting in selected patients.
The product received Breakthrough Device designation, and approval is supported by data from the prospective SELUTION4ISR clinical trial. That study enrolled more than 400 patients across 48 sites in Brazil, Canada, Europe and the US and compared outcomes after treatment with the SELUTION SLR DEB versus standard‑of‑care therapies — about 80% of which involved drug‑eluting stents (DES) in the comparator arm.
At 12 months, the trial reported target lesion failure (TLF) rates of 15.2% for patients treated with SELUTION SLR and 13.5% for those receiving standard therapies; the prespecified primary non‑inferiority endpoint was met in the trial's target population. Cordis also cites broader clinical experience for the technology, noting registry and trial data now encompass more than 5,000 patients worldwide.
Beyond ISR, Cordis has completed enrollment in the SELUTION4DeNovo IDE study, a US‑based trial of 960 patients designed to compare the SELUTION SLR DEB with drug‑eluting stents for de novo lesions in small coronary vessels. Results from that trial are intended to support a future FDA premarket approval submission for the de novo indication.
Clinical and Practical Implications
Drug‑eluting balloons offer a non‑implant approach to deliver antiproliferative drug therapy directly to the vessel wall. For patients with ISR, a DEB can be attractive when operators want to avoid adding another stent layer. The SELUTION SLR device's sustained sirolimus delivery differentiates it from paclitaxel‑coated DEBs and may broaden treatment options for complex coronary lesions, pending operator judgment and individual patient considerations.
Matt Muscari, President of Cordis Americas: "FDA approval of the SELUTION SLR DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care. As the first and only sirolimus drug‑eluting balloon approved in the US, SELUTION SLR DEB introduces a new therapy for the treatment of coronary ISR and will enable physicians to address one of the most complex coronary clinical challenges. The introduction of SELUTION SLR DEB reinforces Cordis' commitment to delivering differentiated technologies that expand treatment possibilities and improve outcomes for patients."
Clinicians should weigh the SELUTION SLR DEB's trial results, broader clinical experience, and individual patient anatomy and risk when selecting therapy. Published peer‑reviewed data and longer‑term follow‑up from ongoing studies will further define the device's role in contemporary coronary practice.
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