{
  "id": 12378896,
  "title": "SELUTION SLR™ wins historic US FDA nod for in‑stent restenosis",
  "url": "https://urgent.news/2026/10/06/selution-slrtm-wins-historic-us-fda-nod-for-in-stent-restenosis",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-10-06T12:06:24.000Z",
  "source": {
    "name": "YourStory",
    "slug": "yourstory",
    "url": "https://yourstory.com/2026/10/selution-slr-wins-historic-us-fda-nod-for-instent-restenosis"
  },
  "original_language": "en",
  "account": "The US Food and Drug Administration has given its approval to SELUTION SLR™, a Drug-Eluting Balloon for coronary in-stent restenosis (ISR). This is the first sirolimus drug-eluting balloon approved for use in the United States. The approval was based on the SELUTION4ISR trial, a large-scale study involving more than 400 patients across multiple countries, which demonstrated non-inferiority against standard-of-care treatment at 12 months. This milestone marks a decade-long effort, thousands of patients, and one of medtech's largest exits. Until now, US physicians treating in-stent restenosis only had a paclitaxel-based option, but SELUTION SLR introduces a sirolimus-based alternative. The technology's creator, co-founder Amit Bohora, sees this FDA approval as a personal and professional milestone, validating years of research and clinical trial work. It also reflects the company's mission to offer a stentless alternative for patients with coronary artery disease. SELUTION SLR is now the only sirolimus drug-eluting balloon in the US market, a significant achievement for the MedAlliance team led by Bohora.",
  "summary": "SELUTION SLR™ wins historic US FDA nod for in‑stent restenosis The US Food and Drug Administration has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon for coronary in-stent restenosis (ISR), Cordis announced this month. This is the first and only sirolimus drug-eluting b",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}