MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system.
The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA).
Geneva, Switzerland-based MedAlliance’s second IDE nod follows the same approval for use of Selution SLR in treating BTK (below-the-knee) indications in May. MedAlliance began enrolling in that trial in June.
Enrollment for the Selution SLR IDE SFA study will begin later this year, according to a news release. The study will be conducted over 20 centers in the U.S. and at an additional 20 centers around the globe.
“This is a significant milestone for MedAlliance: we are the first non-paclitaxel drug-coated balloon to receive IDE approval, and now the first to have two applications approved. This is the culmination of a multi-year R&D program to provide the comprehensive non-clinical data required to satisfy the very high standards expected by the U.S. FDA,” MedAlliance Chair and CEO Jeffrey B. Jump said in the release. “We are very pleased with the rapid level of sales growth we are experiencing in Europe, Asia and South America and very much look forward to entering the U.S. market”.
The company intends to enroll 300 patients to demonstrate superiority over balloon angioplasty (POBA). The Principal Investigator of this study is Dr. George Adams, director of cardiovascular and peripheral vascular research at Rex Hospital Inc., Raleigh, North Carolina.
“We are very excited that US patients suffering from PAD will have the opportunity to receive this novel sirolimus drug-coated balloon technology,” said Adams. “This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly.”
Selution SLR (sustained limus release) features unique micro-reservoirs 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 CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
The platform was granted CE mark approval for treating peripheral artery disease in February 2020, then for treating coronary artery disease in May 2020. FDA has granted Selution SLR four breakthrough nods: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-fistula indications.