MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval
24th October 2022 – SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial. 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.
“We are pleased with the speed of European enrollment and look forward to enrolling the first US patient before the year end; US site selections are underway and will be finalized over the next several weeks. This study has the potential to address the important unmet need of a non-stent treatment for the ongoing problem of in-stent restenosis.” commented Dr Don Cutlip, Principal Investigator of the IDE SELUTION4ISR Study and the Chief Medical Officer at, Baim Institute for Clinical Research.
“This is another significant milestone for MedAlliance: we were the first sustained limus release balloon to receive FDA IDE approval, the first to begin enrollment and now the first to have three applications approved. This is the culmination of a multi-year R&D program that delivered comprehensive pre-clinical data meeting the very high standards of the US FDA”, added Jeffrey B. Jump, MedAlliance Chairman and CEO. “We are very pleased with the high level of market acceptance we are experiencing in Europe, Asia and South America, and we look forward to entering the US market following the successful culmination of this important clinical study and receipt of FDA approval. We are currently enrolling our US Below-the-knee (BTK) study: enrollment is ahead of schedule.
We have had significant success with enrollment of the larger randomized sister study, the international coronary SELUTION DeNovo study, and are excited to offer this new treatment option to US patients, avoiding permanent metal implants. No drug coated balloon is currently approved in the US for coronary indications.”
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. Over 10,000 units have already been used for patient treatment in routine clinical practice or as part of clinical trials.