The first US patient has been enrolled in the US Food and Drug Administration (FDA) SELUTION4BTK (below-the-knee) clinical trial evaluating Selution SLR, MedAlliance‘s novel sirolimus-eluting balloon. This follows investigational device exemption (IDE) approval in the USA in May 2022, with enrolment of the first patient occurring in Germany one week after approval.
“We are very excited to finally have drug-eluting technology in the USA to treat this difficult patient population,” commented the trial’s principal investigator (PI) Ehrin Armstrong (University of Colorado, Denver, USA). “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 in the treatment of BTK arteries in chronic limb-threatening ischaemia (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, USA, by Siddhartha Rao.
“We are very pleased to be participating in this ground-breaking study,” said Rao. “We hope that this promising technology will fulfil a huge need for our patients with CLTI, 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 USA 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.”
MedAlliance advises that Selution SLR is available in Europe and all other countries where the CE mark is recognised.