The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US 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.
Background
We’ve followed the Selution story on our pages for a while, most recently last May when it received FDA IDE approval.
MedAlliance’s unique DEB technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug “sirolimus”. This is applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons. They are then efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized.
Selution Regulatory Status
The device was awarded CE Mark Approval for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive FDA Breakthrough Designation status. The company received FDA IDE approval for BTK and superficial femoral artery (SFA) indications in May and August 2022. It received coronary in-stent restenosis (ISR) IDE approval in October 2022 and de novo coronary artery lesions on January 6th 2023. This will complement the substantial experience that the company has gained with the SELUTION DeNovo trial in Europe.
Enrollment of the IDE SELUTION4ISR FDA coronary study is ongoing outside the US. Furthermore additional US centers will soon join Medstar after this first US enrollment. (ClinicalTrials.gov Identifier: NCT04280029).
The OUS SELUTIONDeNovo study has more than 800 patients of the 3,326 enrolled. This ground-breaking coronary randomized study compares a treatment strategy with SELUTION SLR (DEB) vs. limus drug eluting stent (DES) strategy.
Investigator comments
“We are very excited to have enrolled our first US patient”, commented Dr Don Cutlip, Co-Principal Investigator of the IDE SELUTION4ISR Study and the Chief Medical Officer at Baim Institute for Clinical Research. “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 US. Treating coronary ISR is challenging and having DEB technology made available through a well-designed and conducted randomized clinical trial is the next step. This trial is now underway and this is great for our patients!” added Co-Principal Investigator Prof. Roxana Mehran, Mount Sinai Professor in Cardiovascular Clinical Research and Clinical Trials.
Company comments
“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 R&D program 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.”
Source: MedAlliance
published: January 26, 2023 in: Cardio, Clinical Studies/Trials, Vascular