MedAlliance Selution SLR Receives FDA IDE Approval for SFA Study

August 9, 2022—MedAlliance announced that the company’s Selution SLR sirolimus-eluting balloon has received conditional FDA investigational device exemption (IDE) approval to initiate a pivotal clinical trial of the device for the treatment of occlusive disease of the superficial femoral artery (SFA). The study will be conducted to demonstrate superiority of the device versus plain old balloon angioplasty.

On May 27, the company announced IDE approval for Selution SLR in the treatment of below-the-knee (BTK) indications.

According to MedAlliance, the SELUTION SLR IDE SFA study will enroll 300 patients at > 20 centers in the United States and an additional 20 centers around the world.

George Adams, MD, is Principal Investigator of the SELUTION SLR IDE SFA study and Director of Cardiovascular and Peripheral Vascular Research at Rex Hospital Inc. in Raleigh, North Carolina.

“We are very excited that United States patients suffering from peripheral artery disease will have the opportunity to receive this novel sirolimus drug-coated balloon technology,” commented Dr. Adams in the company’s press release. “This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly.”

According to the company, the Selution SLR technology involves microreservoirs made from biodegradable polymer intermixed with sirolimus that provide the controlled sustained release of the drug. MedAlliance’s Cell Adherent Technology enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon. In February 2020, the device received CE Mark approval in European countries. Selution SLR is available in Europe and all other countries where the CE Mark is recognized, advised the company.