GENEVA, Oct. 25, 2022 /PRNewswire/ -- Following our announcement last week "MedAlliance to be acquired by Cordis", MedAlliance is pleased to make the following announcement:
SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to begin its pivotal coronary clinical trial. This is the first sustained-release coronary drug-eluting balloon (DEB) from limus to receive IDE approval from the FDA for the indication of in-stent restenosis (ISR). The study has already begun enrollment in Europe.
"We are pleased with the speed of enrollment in Europe and hope to enroll the first US patient before the end of the year; US site selections are underway and will be finalized in the coming weeks. This study has the potential to address the significant unmet need for stent-free treatment for the current problem of in-stent restenosis," said Dr. Don Cutlip, Principal Investigator of the IDE SELUTION4ISR study and Medical Director of the Baim Institute for Clinical Research.
"This is another significant milestone for MedAlliance – we were the first slime sustained-release balloon to receive IDE approval from the FDA, the first to begin enrollment, and now the first to have three applications approved. This is the culmination of a program multi-year research and development project that delivered comprehensive preclinical data that meets the very high standards of the US FDA," added Jeffrey B. Jump, president and CEO of MedAlliance. "We are very pleased with the high level of market acceptance we are experiencing in Europe, Asia and South America, and look forward to entering the US market following the successful completion of this important clinical study and receipt of FDA approval. We are currently By enrolling in our US Below Knee (BTK) study, enrollment is early."
"We have had significant success enrolling the largest randomized sister study, the SELUTION DeNovo International Coronary Study, and we are excited to offer this new treatment option to US patients for coronary indications."
MedAlliance was the first drug-eluting balloon company to receive Breakthrough Designation status from the FDA. In addition to the BTK and superficial femoral artery (SFA) indications for which the company received IDE approval from the FDA in May and August 2022, MedAlliance has now received IDE approval for coronary in-stent restenosis (ISR). In the coming weeks, MedAlliance plans to introduce its fourth IDE application, for de novo coronary artery lesions, which will complement the substantial experience the company has gained from the SELUTION DeNovo trial in Europe. More than 540 patients of the 3,326 planned have already been enrolled in this innovative coronary randomized controlled study comparing SELUTION SLR with any limus drug-eluting stent (DES). The study is designed to demonstrate the superiority of SELUTION SLR DEB over DES for de novo coronary 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 in the IDE SELUTION4ISR FDA Coronary Study is now underway in Europe and will begin in the United States later this year. The trial will be conducted at up to 60 centers worldwide and up to 40 centers in the United States. This study is designed to demonstrate noninferiority versus standard of care (80% versus DES and 20% versus POBA), and is currently enrolled at 10% (ClinicalTrials.gov Identifier: NCT04280029).
SELUTION SLR received CE Mark approval for the treatment of peripheral arterial disease in February 2020 and for the treatment of coronary artery disease in May 2020.
MedAlliance's exclusive DEB technology involves MicroReservoirs that contain a blend of biodegradable polymers intermixed with the antirestenotic drug sirolimus applied as a coating on the surface of an angioplasty balloon. These microreservoirs provide controlled and sustained drug release for up to 90 days1.
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 and more than 10,000 units have already been used treating patients in practice routine clinic or as part of clinical trials.
Contact: Richard Kenyon, rkenyon@medalliance.com, 44 7831 569940
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