1 hr ago
FDA Approves SELUTION SLR Balloon for In-Stent Restenosis
The FDA approved a balloon called SELUTION SLR for treating arteries that narrow again inside an existing stent.
A stent is a small device placed in an artery to help keep it open.
Sometimes the artery becomes narrow again, which is called in-stent restenosis.
The balloon delivers a medicine called sirolimus to the artery wall.
It releases the medicine over about 90 days and does not stay inside the body.
A clinical study with more than 400 patients found that it performed no worse than the usual treatment after one year.
The device was originally developed by MedAlliance and is now owned and sold by Cordis.
Amit Bohora, a MedAlliance cofounder, called the approval an important milestone for treatment without permanent metal implants.
The U.S. Food and Drug Administration approved Cordis’s SELUTION SLR sirolimus drug-eluting balloon for coronary in-stent restenosis.
The SELUTION4ISR trial involved more than 400 patients at 48 sites and met its 12-month non-inferiority endpoint against standard treatment.
The device is described as the first and only sirolimus drug-eluting balloon approved for use in the United States.
SELUTION SLR delivers sirolimus over roughly 90 days without leaving a permanent implant behind.
Cordis has completed enrollment in a separate 960-patient U.S. trial involving small coronary vessels, potentially supporting a future FDA filing.
- Who
- The U.S. Food and Drug Administration, Cordis, MedAlliance cofounder Amit Bohora, and patients with coronary in-stent restenosis.
- What
- The FDA approved SELUTION SLR, a sirolimus drug-eluting balloon, for treating coronary in-stent restenosis.
- Where
- The approval applies to use in the United States; the supporting trial was conducted across 48 sites in the United States, Canada, Brazil, and Europe.
- When
- The approval was announced in September, with the article dated September 25; the SELUTION4ISR trial assessed outcomes at 12 months.
- Why
- The device is intended to treat artery re-narrowing inside a previous stent while delivering sirolimus without leaving another permanent implant.
Key facts
- Device
- SELUTION SLR Sustained Limus Release Drug-Eluting Balloon
- Approved use
- Coronary in-stent restenosis
- Regulator
- U.S. Food and Drug Administration
- Clinical evidence
- SELUTION4ISR randomized, multicenter trial with more than 400 patients across 48 sites
- Trial result
- Met its primary 12-month non-inferiority endpoint against standard-of-care treatment
- Drug delivery
- Sirolimus released to the vessel wall over roughly 90 days
- Current owner
- Cordis
Quotes
Dr. Praveen Chandra
Principal investigator of the SELUTION First-in-Man clinical trial
“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.”
theprint.in
“U.S. FDA approval is not just a commercial win; it is a clinical victory for millions living with coronary artery disease.”
theprint.in
Sources
Related news
Sahajanand Medical Technologies Gains EU MDR Certification for Supraflex Cruz
Dr. Amit Singh Named Cardiologist of Year at ET Awards
Transcranial Pulse Stimulation for Alzheimer’s Now Available in India
Meril Launches HALO Stem and Latitud Revision Cup
Hyderabad Men Die from Stolen Anaesthesia Drug
Cordis Selution Trials Show Positive Results
MedAlliance's Drug-Eluting Balloon Revolutionizes Heart Care