MedAlliance has announced enrollment of over 1,660 patients in its ground-breaking SELUTION DeNovo coronary randomized study. Recruitment is now half way towards a planned 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon (SELUTION SLR), versus any limus drug-eluting stent (DES).
SELUTION DeNovo is the largest DEB study ever initiated, involving 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 non-inferiority at both one and five years, and superiority for target vessel failure (TVF) at five years.
This study is designed to change medical practice, as the majority of de novo coronary lesions are currently treated with a permanent metallic stent. SELUTION SLR consists of an angioplasty balloon coated with MicroReservoirs containing a mixture of biodegradable polymer and the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for over 90 days, similar to a DES, but without leaving behind a metal stent, which has been associated with a complication rate of 2% annually.
“This is a major milestone for the SELUTION DeNovo trial, as it is now the largest DEB study ever conducted,” said Co-Principal Investigator Professor Christian Spaulding, Cardiology Department, European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris and Paris Cité University, Paris, France. “The study is performed in a true all-comers population and is not just looking at small vessel artery disease. It is encouraging that the Drug and Safety Monitoring Board has no concerns, voting unanimously for the trial to continue as planned, as there are no worrying protocol deviations and no significant differences between the groups. We see investigators being comfortable using this novel approach and expect the enrollment to be completed within the next 12 months.”
“This trial has the potential to change medical practice, not only in Europe, but also in the US, China and Japan, benefitting patients around the globe,” added Jeffrey B. Jump, MedAlliance Chairman and CEO. “We are currently enrolling US patients in our IDE coronary ISR, peripheral BTK and SFA studies. The coronary SELUTION4DeNovo IDE trial is due for enrolling its first US patient at the beginning of Q4 2023.”
SELUTION SLR was awarded CE Mark Approval for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive FDA Breakthrough Designation status. In addition to the BTK and superficial femoral artery (SFA) indications for which the company received FDA IDE approval in May and August 2022, MedAlliance received coronary in-stent restenosis (ISR) IDE approval in October 2022 and de novo coronary artery lesions approval on January 6th 2023. This will complement the substantial experience that the company has gained with the SELUTION DeNovo trial in Europe.
MedAlliance’s unique DEB technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 40,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.