MedAlliance today announced it received FDA investigational device exemption (IDE) approval for its Selution SLR to initiate its coronary pivotal clinical trial for in-stent restenosis.
Geneva-based MedAlliance’s Selution SLR is a drug-eluting balloon that is indicated for below-the-knee and superficial femoral artery (SFA) indications, for which it received IDE approval in May and August this year, respectively.
The device becomes one of the first sustained limus release coronary drug-eluting balloons (DEB) to receive FDA IDE approval for in-stent restenosis, according to MedAlliance. It has already begun enrollment in the trial 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,” said Don Cutlip, principal investigator of the IDE study and chief medical officer at Baim Institute for Clinical Research.
In the coming weeks, MedAlliance plans to submit another IDE application for de novo coronary artery lesions to complement the substantial experience the company had with the Selution DeNovo trial in Europe.
MedAlliance last week announced that it would be acquired by Cordis for an initial $235 million. The total value of the deal could reach over $1.135 billion as Cordis will pay regulatory achievement milestones and commercial milestone payments.
About the clinical trial
More than 540 patients have been enrolled so far and the trial plans to enroll 3,326 patients in total. The study will compare Selution SLR to any limus drug-eluting stent to “demonstrate superiority” for coronary de novo artery disease.
“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 U.S. for coronary indications,” CEO Jeffrey Jump said in a news release.
MedAlliance plans to begin enrollment in its IDE Selution4ISR FDA coronary study and start the trial in the U.S. later this year. The trial will, overall, be conducted at up to 60 centers worldwide and in up to 40 centers in the U.S.
Selution SLR has unique micro reservoirs that are made of biodegradable polymer intermixed with sirolimus. The micro reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s cell-adherent technology allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
The device is commercially available in Europe, Asia, the Middle East and the Americas outside of the U.S. and most other countries where CE mark is recognized.