FDA Cleared First Sirolimus Drug-Eluting Balloon
Operators in interventional cardiology now have a stentless alternative for treating in-stent restenosis.
Updated on Oct. 2, 2026 in Healthcare
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The FDA has cleared the SELUTION SLR drug-eluting balloon for use in the United States, marking the first sirolimus-based device of its kind approved for treating coronary in-stent restenosis. The device, which avoids the need for permanent implants, is expected to impact clinical practices involved in the one million annual percutaneous coronary interventions performed in the country.
Why it matters
This approval introduces a non-permanent treatment option for the 1 in 10 patients who develop in-stent restenosis annually after initial stent procedures. It validates a strategy previously cemented by Cordis’s $1.135 billion acquisition of developer MedAlliance in October 2023.
The approval covers a device already sold in 65 countries and used on 250,000 patients globally, following the $1.135 billion acquisition of MedAlliance. The device delivers drug therapy over 90 days.
The players
FDA
The federal agency responsible for regulating medical device approvals and ensuring safety standards for health-related products in the United States.
Cordis
A developer and manufacturer of interventional cardiovascular technology that operates on a global scale.
MedAlliance
The Swiss-based research and development firm that created the SELUTION SLR balloon technology prior to its acquisition.
The details
The SELUTION SLR balloon uses Sustained Limus Release technology to deliver sirolimus to the vessel wall over a 90-day period. Because the device does not leave behind a permanent metallic implant, it functions as a stentless alternative for physicians managing narrowed arteries. Clinical data from 400 patients across 48 sites demonstrated that the device met non-inferiority endpoints compared to existing standard-of-care treatments.
Timeline
Cordis acquired MedAlliance in October 2023.
The FDA approved the SELUTION SLR balloon in October 2026.
Market Landscape
The FDA clearance follows the $1.135 billion valuation set by the 2023 Cordis acquisition of MedAlliance. This move signals a shift toward non-permanent, drug-eluting vascular therapies as a major competitive alternative to traditional stenting.
Operators in interventional cardiology should monitor local adoption and physician training requirements for this new class of stentless devices. Facilities should evaluate existing inventory and procurement contracts regarding stenting supplies in anticipation of potential procedural shifts.
The takeaway
The arrival of a stentless, drug-eluting balloon provides a new pathway for managing in-stent restenosis without adding additional permanent hardware. Clinic managers should track the 960-patient trial results for the secondary FDA submission to gauge when this technology might expand into broader coronary indications.
Further reading
For broader trends in medical technology regulation, see Healthcare.
Source note: This article includes information reported by MoneyControl.
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