MedAlliance announced today that the first U.S. patient was enrolled in a U.S. clinical trial of its novel sirolimus-eluting balloon.
Geneva, Switzerland-based MedAlliance received FDA investigational device exemption (IDE) approval for its Selution SLR drug-eluting balloon in the below-the-knee procedures. One week later, the company enrolled the first patient in its multi-center FDA Selution4BTK trial in Germany.
The company designed Selution SLR (sustained limus release) with 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.
“We are very excited to finally have drug-eluting technology in the US to treat this difficult patient population,” said the trial’s principal investigator Dr. Ehrin Armstrong. “We are encouraged by the positive early outcomes with this novel Selution SLR sirolimus drug-eluting balloon (DEB) in Europe and Asia. We hope this FDA IDE trial will demonstrate significant benefit for patients who currently have limited treatment options.”
The company said in a news release that the aim of the prospective, multi-center, single-blinded, randomized trial is to demonstrate the superior efficacy and equivalent safety of Selution SLR compared to plain (uncoated) balloon angioplasty (POBA) in the treatment of BTK arteries in chronic limb-threatening ischemia (CLTI) patients.
In total, 377 subjects will be randomized 1:1 to Selution SLR or control. MedAlliance said it represents the first study of its kind in which real-world patients with CLTI can be included.
Patients will be enrolled across approximately 40 sites in the U.S., Europe and Asia. The first U.S. patient was enrolled at Vascular Solutions in Cary, North Carolina by Dr. Siddhartha Rao.
“We are very pleased to be participating in this groundbreaking study,” Rao said. “We hope that this promising technology will fulfill a huge need for our patients with chronic limb-threatening ischemia, saving life and limb. We look forward to the rapid enrolment of this trial.”
Selution SLR holds CE mark approval for treating peripheral artery disease and for treating coronary artery disease. It has four FDA breakthrough device designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.
“We were the first company to be granted “breakthrough device designation” for a DEB by the FDA and are proud to enrol the very first U.S. patient in a sirolimus DEB study” said Jeffrey B. Jump, MedAlliance Chair and CEO. “Many companies have been trying for years to bring sirolimus to the US and we are very pleased with our team for achieving this significant milestone. U.S. patients will now have an alternative to paclitaxel DEB, addressing the concerns expressed by the FDA.”
