MedAlliance’s Selution SLR Gets Conditional IDE Approval

MedAlliance has gained the FDA’s conditional Investigational Device Exemption (IDE) approval to begin a clinical trial of its Selution SLR (sustained limus release) drug-eluting balloon for treatment of patients with occlusive disease of the superficial femoral artery.

The device delivers the immunosuppressive drug sirolimus with a sustained release profile similar to that of a drug-eluting stent.

The company will use the results of the study to support its application for approval of the device for patients with the peripheral artery disease that includes a narrowing or blockage of the vessels that carry blood from the heart to the legs.

Earlier this year, the company received IDE approval for the device for treatment of peripheral artery disease below-the-knee.