FDA Approves Breakthrough's Selution SLR Drug-Eluting Balloon for Coronary ISR
What happened
The U.S. Food and Drug Administration has approved the Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) manufactured by Breakthrough. This device is intended for the treatment of coronary in-stent restenosis (ISR) and delivers sustained sirolimus therapy without creating a permanent implant. The approval follows the device being designated as a Breakthrough Device and is supported by results from the SELUTION4ISR trial.
From dicardiology.com
Why it matters
The approval establishes the Selution SLR DEB as the first sirolimus drug-eluting balloon approved in the United States for this indication. This introduction provides physicians with immediate access to a groundbreaking therapy for complex coronary clinical challenges, significantly advancing the field of cardiovascular care.
From dicardiology.com
Who's involved
- BreakthroughManufacturer of the Selution SLR Drug-Eluting Balloon
- FDARegulatory body that granted the device approval
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The entities involved
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Breakthrough
company in New York, United States
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Europe
terrestrial continent located in north-western Eurasia
- FDA
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