Home / Health / MedTech Milestone: Sirolimus Balloon FDA Approved
MedTech Milestone: Sirolimus Balloon FDA Approved
6 Oct
Summary
- First and only sirolimus drug-eluting balloon approved in the US.
- Technology co-founded by Amit Bohora sold for $1.135 billion.
- SELUTION SLR addresses in-stent restenosis, a common complication.
The SELUTION SLR™ drug-eluting balloon has achieved a historic milestone with its recent FDA approval in the United States. This marks the first and only sirolimus-eluting balloon available in the US market for coronary in-stent restenosis. The technology was co-founded by Amit Bohora at MedAlliance, a company later acquired by Cordis for $1.135 billion in October 2023.
This approval, validated by the SELUTION4ISR trial involving over 400 patients, signifies a major advancement. It offers a sirolimus-based alternative to the previously limited paclitaxel options for treating artery re-narrowing within stents. Bohora's decade-long vision for a stentless alternative is now a reality.
Globally, SELUTION SLR™ is already available in over 65 countries and has treated more than 250,000 patients. Its US clearance is a testament to years of research and clinical trials, culminating in a significant achievement for cardiovascular care innovation.
