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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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.
The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.
The SMART trial will compare Medtronic’s Evolut TAVR systems to Edward’s Sapien 3 devices. Evolut EXPAND TAVR I will evaluate Evolut in patients with symptomatic moderate aortic stenosis or asymptomatic severe disease.