The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR(TM), MedAlliance’s novel sirolimus-eluting balloon, just one week after receiving IDE approval.
“I am excited to begin an important trial which will establish the evidence that this novel technology benefit patients suffering from CLTI,” commented Dr. Michael Lichtenberg, Chief of the Angiology Department at the Klinikum Hochsauerland, Arnsberg, Germany. “So far nothing has worked consistently in this patient population. The early clinical data from SELUTION SLR registries are encouraging and I have seen the performance of this new technology in my routine work. This study is designed to prove that SELUTION SLR is more effective than the current standard of care in this difficult patient population.”
The start of enrollment in the study follows IDE (Investigational Device Exemption) approval in the US one week ago. The BTK indication for SELUTION SLR was granted Breakthrough Device Designation by the FDA in 2019.
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 CLTI (Chronic Limb Threatening Ischemia) patients. The trial is a prospective, multi-center, single blinded, randomized study.
377 subjects are being randomized 1:1 to either SELUTION SLR or the control. This is the first study of its kind where ‘real world’ patients with CLI (Critical Limb Ischemia) can be included. Patients are being enrolled at approximately 40 sites across the US, Europe and Asia.
“I am very proud of the MedAlliance team which has been able to initiate this study so quickly and have the first patient enrolled only a week after receiving IDE approval,” commented Jeffrey B. Jump, MedAlliance Chairman and CEO. “This is a great achievement and a major milestone for MedAlliance.”
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]. This 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.
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MedAlliance is a privately-owned medical technology company. It is headquartered in Nyon, Switzerland, with offices in Germany, Singapore, UK and USA. MedAlliance specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. For further information visit: www.medalliance.com
1. Drug concentration evident in MicroReservoirs and tissue – Data on file at M.A. Med Alliance SA