MedAlliance Launches PRISTINE Study Of SELUTION SLR Drug-Eluting Peripheral Balloon
SELUTION SLR is the first drug-eluting balloon accepted by the FDA as part of its breakthrough program, according to the company.
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Trustar Capital’s investment will allow MedAlliance to pursue commercialization of its drug eluting balloon and further its trial efforts.
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.
The Swiss company is rolling out the sirolimus-eluting balloon catheter in Europe and sponsoring trials in the US. The FDA has granted it breakthrough status for three different indications.