The FDA has given Spectranetics approval for its Stellarex drug-coated balloon, a device intended for use in treating peripheral artery disease and superficial femoral or popliteal lesions. The approval was backed by results from the ILLUMENATE pivotal trial, which showed use of the balloon led to low clinically driven target lesion revascularization rates and high patency rates for a wide range of lesion complexities and patient comorbidities.
Spectranetics' drug-coated balloon wins FDA approval
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