Selution SLR, MedAlliance's novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial.
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This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval for In-stent Restenosis (ISR) indication.
The study has already begun enrollment in Europe.
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 has now received coronary in-stent restenosis (ISR) IDE approval.
In the next few weeks, MedAlliance plans to submit its 4th IDE application, for de novo coronary artery lesions, which will complement the substantial experience that the company has gained with the Selution DeNovo trial in Europe.
More than 540 patients of the 3,326 planned have already been enrolled in this ground-breaking coronary randomized controlled study comparing Selution SLR vs. any limus drug-eluting stent (DES).
The study is powered to demonstrate superiority of Selution SLR DEB over DES for coronary de novo artery disease. This is the largest DEB study ever initiated and has the potential to change medical practice where implants (metal stents) have been the standard of care for more than 30 years.
Enrollment of the IDE Selution4ISR FDA coronary study is already ongoing in Europe, and will start in the US later this year. The trial will be conducted at up to 60 centers worldwide, and in up to 40 centers in the US.
This study is powered to demonstrate non-inferiority vs. standard of care, (80% against DES and 20% against POBA), and is currently 10% enrolled (ClinicalTrials.gov Identifier: NCT04280029).
Selution SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020.
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.
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 and over 10,000 units have already been used for patient treatments in routine clinical practice or as part of clinical trials. ■