Cordis announced that it has received approval from the U.S. Food and Drug Administration (US FDA) for the SELUTION SLR™ (Sustained Limus Release) balloon, designed to treat in-stent restenosis (ISR) of coronary arteries. This is the first and only sirolimus-eluting balloon approved for use in the United States.
For Amit Bohora, who co-founded MedAlliance and helped transform SELUTION SLR from an early research concept into a globally commercialized therapy before Cordis acquired the company in October 2023 for $1.135 billion, this approval represents a personal achievement in the technology he developed over more than ten years.
The achievement is the result of over a decade of work, involving thousands of patients and one of the largest recent exits in medical technology. The approval is based on the SELUTION4ISR study—a multicenter randomized trial involving over 400 patients across 48 centers in the US, Canada, Brazil, and Europe. This study met its primary endpoint of non-inferiority compared to standard treatment after 12 months.
This complements a clinical database covering over 5,000 patients worldwide. Furthermore, Cordis confirmed the completion of patient enrollment in a US study of 960 patients, which evaluates the balloon for new lesions in small coronary vessels, paving the way for a second FDA submission.
Nearly one million percutaneous coronary interventions are performed annually in the US, and approximately 10% of these cases require treatment for in-stent restenosis, which is the narrowing of an artery inside a previously placed stent. Until now, physicians in the US who used drug-eluting balloons for such cases only had options based on paclitaxel. SELUTION SLR changes this situation by becoming the first sirolimus-based alternative available in the country.
Commenting on the technology, Bohora noted that when creating SELUTION at MedAlliance, the goal was never just to create another device; he aimed to provide physicians with a genuine implant-free alternative for patients suffering from coronary artery diseases. He stated: 'Seeing the therapy now approved by the USFDA for treating stent restenosis, one of the most complex problems in interventional cardiology, is an incredibly proud moment. It validates years of research, clinical trial work, and the conviction that sustained release of sirolimus without a permanent implant can change how doctors approach re-treating a narrowed artery.'
During his time at the company, Bohora led MedAlliance's clinical programs, regulatory approvals, and global expansion, including establishing R&D facilities in Switzerland and Singapore, as well as manufacturing capabilities in the US. He emphasized: 'What started as an opposing belief that cardiology should be free from permanent metal has achieved the world's strictest regulatory scrutiny. The US FDA approval is not just a commercial victory; it is a clinical victory for millions of people living with coronary artery diseases.'
Bohora added that MedAlliance sought to prove that visionary entrepreneurship, based on deep science, could redefine global healthcare. He remarked: 'Our acquisition by Cordis for $1.135 billion strengthened this mission. The fact that SELUTION SLR™ opens the American market proves that transformative Indian leadership and global innovation can permanently change the paradigm of cardiovascular care.'
Dr. Praveen Chandra, lead investigator of the first SELUTION clinical trial, shared his clinical assessment. He reported: 'Leading the first-in-human clinical trial for SELUTION, I saw from the beginning how sustained delivery of sirolimus could fundamentally change vascular healing without adding more metal. This FDA approval is a historical confirmation of that science. It reflects Amit's uncompromising dedication to a translational clinical rigorous approach, turning a bold idea into a therapy that now transforms lives worldwide.'
SELUTION SLR is now the only sirolimus-eluting balloon on the US market, a category that the MedAlliance team under Bohora effectively created long before the science was proven on such a scale. This device, commercially available in over 65 countries and used to treat more than 250,000 patients globally, receives approval in the US under the current owner, Cordis, marking a milestone few medical technology founders get to see: the invention they helped create becomes the standard of care in the world's most demanding regulatory market.