GENEVA, Oct. 25, 2022 /PRNewswire/ — Following our communication final week “MedAlliance to be acquired by Cordis”, MedAlliance is happy to make the next announcement:
SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has obtained FDA Investigational Device Exemption (IDE) approval to provoke its coronary pivotal medical trial. This is the primary sustained limus launch coronary drug eluting balloon (DEB) to obtain FDA IDE approval for In-stent Restenosis (ISR) indication. The research 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 ahead to getting into the US market following the profitable end result of this vital medical research and receipt of FDA approval. We are at present enrolling our US Below-the-knee (BTK) research, enrollment is forward 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 primary drug-eluting balloon firm to obtain FDA Breakthrough Designation standing. In addition to the BTK and superficial femoral artery (SFA) indications for which the corporate obtained FDA IDE approval in May and August 2022, MedAlliance has now obtained coronary in-stent restenosis (ISR) IDE approval. In the following few weeks, MedAlliance plans to submit its 4th IDE software, for de novo coronary artery lesions, which can complement the substantial expertise that the corporate has gained with the SELUTION DeNovo trial in Europe. More than 540 sufferers of the three,326 deliberate have already been enrolled on this ground-breaking coronary randomized managed research evaluating SELUTION SLR vs. any limus drug-eluting stent (DES). The research is powered to show superiority of SELUTION SLR DEB over DES for coronary de novo artery illness. This is the most important DEB research ever initiated and has the potential to alter medical apply the place implants (metallic stents) have been the usual of take care of greater than 30 years.
Enrollment of the IDE SELUTION4ISR FDA coronary research is already ongoing in Europe, and can begin within the US later this 12 months. The trial shall be performed at as much as 60 facilities worldwide, and in as much as 40 facilities within the US. This research is powered to show non-inferiority vs. normal of care, (80% towards DES and 20% towards POBA), and is at present 10% enrolled (ClinicalTrials.gov Identifier: NCT04280029).
SELUTION SLR was awarded CE Mark Approval for the therapy of peripheral artery illness in February 2020 and for the therapy of coronary artery illness in May 2020.
MedAlliance’s distinctive DEB know-how entails MicroReservoirs which include a mix of biodegradable polymer intermixed with the anti-restenotic drug sirolimus utilized as a coating on the floor of an angioplasty balloon. These MicroReservoirs present managed and sustained launch of the drug for as much as 90 days1.
SELUTION SLR is commercially obtainable in Europe, Asia, the Middle East and the Americas (exterior USA) and most different nations the place the CE Mark is acknowledged and over 10,000 models have already been used for affected person therapies in routine medical apply or as a part of medical trials.
Contact: Richard Kenyon, [email protected], +44 7831 569940
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