MedAlliance has announced enrolment of over 1,000 patients in its SELUTION DeNovo coronary randomised study. Recruitment is now a third of the way towards the target of 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon (DEB), Selution, versus a limus drug-eluting stent (DES).
SELUTION DeNovo involves up to 70 participating sites across 15 countries. Patients are randomised 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.
Selution SLR consists of an angioplasty balloon coated with MicroReservoirs containing a mixture of biodegradable polymer and the antirestenotic drug sirolimus. The MicroReservoiris are intended to provide controlled and sustained release of the drug for over 90 days, similar to a DES, but without leaving behind a metal scaffold.
“This is a major milestone for the SELUTION DeNovo trial, as it is now the largest DEB study ever conducted,” said co-principal investigator Christian Spaulding (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. The results will have a major impact on clinical practice.”
“This trial has the potential to change medical practice, not only in Europe, but also in the USA, China and Japan, benefitting patients around the globe,” added Jeffrey B Jump, MedAlliance Chairman and CEO. “We are currently enrolling US patients in our coronary ISR IDE and BTK studies in the US and Europe.”
Selution SLR was awarded CE mark for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive US Food and Drug Administration (FDA) breakthrough designation status. In addition to the below the knee (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 6 January 2023.
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 recognised. Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.