The first patient has been enrolled in the US Food and Drug Administration (FDA) investigational device exemption (IDE) below-the-knee (BTK) SELUTION4BTK clinical trial involving SELUTION SLR, MedAlliance’s sirolimus-eluting balloon.
Michael Lichtenberg, chief of the angiology department at the Klinikum Hochsauerland (Arnsberg, Germany), said: “I am excited to begin an important trial which will establish the evidence that this novel technology benefit patients suffering from critical limb threatening ischaemia (CLTI).
“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 enrolment in the study follows IDE 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 patients. The trial is a prospective, multicentre, single blinded, randomised study.
A total of 377 patients will be randomised 1:1 to either SELUTION SLR or the control. According to MedAlliance, this is the first study of its kind where real-world patients with critical limb ischaemia 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”, added Jeffrey 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.