No more metal: World’s first sirolimus drug balloon wins landmark US FDA approval

As per the latest business developments, The US Food and Drug Administration (FDA) has approved the SELUTION SLR drug-eluting balloon for treating coronary in-stent restenosis, the re-narrowing of an artery inside a previously placed stent. Cordis, the device's owner, announced the decision this month. It is the first sirolimus-based drug-eluting balloon cleared for use in the United States.

Until now, American physicians seeking a drug-coated balloon for such cases have had only a paclitaxel-based product available. The US performs close to one million percutaneous coronary interventions (PCI) a year, and roughly one in 10 involves in-stent restenosis.

The approval was based on the SELUTION4ISR trial, a randomised, multicentre study of more than 400 patients at 48 sites across the United States, Canada, Brazil and Europe. The balloon met its primary endpoint of non-inferiority against standard-of-care treatment at 12 months. The wider body of clinical evidence for the device now covers more than 5,000 patients worldwide.

The balloon uses a technology called Sustained Limus Release, which delivers sirolimus to the vessel wall over around 90 days and leaves no permanent implant behind. It is sold in more than 65 countries and has been used to treat more than 250,000 patients.

Cordis stated it has additionally completed enrolment in a separate US trial involving 960 patients, testing the balloon on de novo lesions in small coronary vessels. The trial is anticipated to backing a second FDA submission.

The technology was developed by MedAlliance, a Swiss medical technology firm. Cordis acquired MedAlliance in October 2023 in a deal valued at $1.135 billion.

Amit Bohora, a co-founder who led the firm's clinical programmes, regulatory approvals and global expansion, stated the FDA decision was "an incredibly proud moment". He further noted that the firm had set out to give physicians a stentless alternative for patients with coronary artery disease.

“When we set out to build SELUTION at MedAlliance, the goal was never simply to create another device – it was to give physicians a genuine, stentless alternative for patients living with coronary artery disease. Seeing the therapy now approved by the USFDA for in-stent restenosis, one of the toughest problems in interventional cardiology, is an incredibly proud moment. It validates years of research, clinical trial work, and the conviction that sustained sirolimus release, without a permanent implant, could change how physicians think around re-treating a narrowed artery,” he stated.

Bohora oversaw the building of research and development facilities in Switzerland and Singapore, along with manufacturing capacity in the United States. He is not affiliated with Cordis and does not speak for the firm.

Dr Praveen Chandra, principal investigator of the first-in-human SELUTION trial, described the approval as "a historic vindication of that science", referring to the case for sustained sirolimus delivery without additional metal in the artery.