MedAlliance’s SELUTION DeNovo Study Reaches Enrollment Milestone

March 14, 2023—MedAlliance announced an update on the progress of enrollment in its SELUTION DeNovo coronary randomized study, which commenced in 2021.

SELUTION DeNovo compares the company’s Selution SLR sirolimus drug-eluting balloon (DEB) versus a limus drug-eluting stent for the treatment of coronary artery disease. The company advised that the trial has now enrolled more than 1,000 patients of a targeted 3,326 patients.

According to MedAlliance, the SELUTION DeNovo study involves up to 70 participating sites across 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias. The objectives of the study are to demonstrate noninferiority of the Selution DEB at both 1 and 5 years, and superiority for target vessel failure at 5 years.

MedAlliance stated that Selution SLR consists of an angioplasty balloon coated with microreservoirs containing a mixture of biodegradable polymer and the antirestenotic drug sirolimus. The microreservoirs provide controlled and sustained release of the drug for more than 90 days, similar to a drug-eluting stent but without leaving behind a metal scaffold, which has been associated with a complication rate of 2% annually, noted the company.

“This is a major milestone for the SELUTION DeNovo trial, as it is now the largest DEB study ever conducted,” commented Coprincipal Investigator Professor Christian Spaulding, MD. “The study is performed in a true all-comers population and is not just looking at small vessel artery disease. The results will have a major impact on clinical practice.” Prof. Spaulding is with the Cardiology Department, European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, and Paris Cité University in Paris, France.

Selution SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside the United States), and most other countries where the CE Mark is recognized.

The company advised that Selution SLR was awarded CE Mark approval for the treatment of coronary artery disease in May 2020. In February 2019, MedAlliance announced Selution SLR was granted FDA Breakthrough Device designation.

MedAlliance received FDA investigational device exemption (IDE) approvals for coronary in-stent restenosis (ISR) in October 2022 and de novo coronary artery lesions in January 2023. Additionally, IDE approvals for below-the-knee (BTK) and superficial femoral artery indications were granted in May 2022 and August 2022, respectively.

Jeffrey B. Jump, MedAlliance Chairman and CEO, stated, “This trial has the potential to change medical practice, not only in Europe, but also in the United States, China, and Japan, benefitting patients around the globe. We are currently enrolling United States patients in our coronary ISR IDE and BTK studies in the United States and Europe.”