The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon.
This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval.
“We are very excited to finally have drug-eluting technology in the US to treat this difficult patient population,” commented the trial’s Principal Investigator (PI) 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 aim of the SELUTION4BTK clinical 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. The trial is a prospective, multi-center, single blinded, randomized study (ClinicalTrials.gov Identifier: NCT05055297).
377 subjects are being randomized 1:1 to either SELUTION SLR or control treatment. This is the first study of its kind where ‘real world’ patients with CLTI can be included. Patients are being enrolled at approximately 40 sites across the US, Europe and Asia. This first US 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,” said Dr Rao, “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.”
“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 US patient in a sirolimus DEB study,” added Jeffrey B. Jump, MedAlliance Chairman 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. US patients will now have an alternative to paclitaxel DEB, addressing the concerns expressed by the FDA.”
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomized controlled study comparing SELUTION SLR with a limus drug-eluting stent (DES), powered to demonstrate superiority. SELUTION DeNovo is the largest DEB study ever initiated and has the potential to change medical practice.
MedAlliance’s DEB technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days1. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.
SELUTION SLR is available in Europe and all other countries where the CE Mark is recognized.