The first US patient has been enrolled at Medstar Washington Hospital Center (Washington DC, USA) in the SELUTION4ISR study evaluating Selution SLR to support US Food and Drug Administration (FDA) approval. This follows investigational device exemption (IDE) approval in the USA in October 2022.
Selution SLR is the first sustained limus release coronary drug-eluting balloon (DEB) to receive FDA IDE approval for In-Stent Restenosis (ISR) indications.
“We are very excited to have enrolled our first US patient”, commented Don Cutlip, co-principal investigator of the IDE SELUTION4ISR study and the chief medical officer at Baim Institute for Clinical Research (Boston, USA). “This study addresses the important unmet need of treatment for the ongoing problem of in-stent restenosis without adding an additional layer of metal stent.”
“This is an exciting day for PCI in the USA. DEB is the standard of care for ISR around the world, with the exception of the USA. Treating coronary ISR is challenging and having DEB technology made available through a well-designed and conducted randomised clinical trial is the next step. This trial is now underway and this is great for our patients,” added co-principal investigator Roxana Mehran, (Icahn School of Medicine at Mount Sinai, New York, USA).
“This is another significant milestone for MedAlliance: we were the first sustained limus release balloon to receive FDA IDE approval, the first to treat a US peripheral patient and now the first to treat a US coronary patient. This is the culmination of a multi-year research and development programme that delivered comprehensive pre-clinical data meeting the very high standards of the US FDA”, added Jeffrey B Jump, MedAlliance chairman and CEO. “We are very pleased with the high level of market acceptance we are experiencing in Europe, Asia and South America, and we look forward to entering the US market following FDA approval.”