SELUTION4BTK Trial Evaluating MedAlliance’s Selution SLR Sirolimus-Eluting Balloon for CLTI Enrolls First Patient In United States

August 22, 2022—MedAlliance announced that the first United States patient was enrolled in the SELUTION4BTK clinical trial evaluating the company’s Selution SLR sirolimus-eluting balloon, following the device receiving conditional investigational device exemption (IDE) by the FDA in May 2022.

According to the company, the goal of SELUTION4BTK is to demonstrate the superior efficacy and equivalent safety of the Selution SLR versus plain old balloon angioplasty (POBA) for the treatment of below-the-knee arteries in patients with chronic limb-threatening ischemia (CLTI).

SELUTION4BTK is a prospective, multicenter, single-blinded trial, and it is intended to enroll 377 patients randomized 1:1 to either Selution SLR or POBA.

Siddhartha Rao, MD, enrolled the first patient from the United States at Vascular Solutions in Cary, North Carolina.

“We are very pleased to be participating in this groundbreaking study,” said Dr. Rao in the company’s announcement. “We hope that this promising technology will fulfill a huge need for our patients with CLTI, saving life and limb. We look forward to the rapid enrollment of this trial.”

In addition to the United States, patients are being enrolled in the trial in Europe and Asia at approximately 40 sites. The first patient was enrolled in Germany in June 2022.

“We are encouraged by the positive early outcomes with this novel Selution SLR sirolimus drug-eluting balloon in Europe and Asia,” commented the study’s Principal Investigator Ehrin J. Armstrong, MD, in the company’s announcement. “We hope this FDA IDE trial will demonstrate significant benefit for patients who currently have limited treatment options.” Dr. Armstrong is Director of the Adventist Heart and Vascular Institute at Adventist Health in St. Helena, California.

The Selution SLR was granted CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. It is available in Europe and all other countries where the CE Mark is recognized.