Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, has received US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its coronary pivotal clinical trial.
This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval for in-stent restenosis (ISR) indication. The study has already begun enrolment in Europe.
“We are pleased with the speed of European enrolment and look forward to enrolling the first US patient before the year end; US site selections are underway and will be finalised over the next several weeks. This study has the potential to address the important unmet need of a non-stent treatment for the ongoing problem of in-stent restenosis,” commented Don Cutlip, principal investigator of the IDE SELUTION4ISR Study and the chief medical officer at Baim Institute for Clinical Research (Boston, USA).
“This is another significant milestone for MedAlliance: we were the first sustained limus release balloon to receive FDA IDE approval, the first to begin enrolment and now the first to have three applications approved. 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 the successful culmination of this important clinical study and receipt of FDA approval. We are currently enrolling our US below-the-knee (BTK) study: enrolment is ahead of schedule.
“We have had significant success with enrolment of the larger randomised sister study, the international coronary SELUTION DeNovo study, and are excited to offer this new treatment option to US patients, avoiding permanent metal implants. No drug coated balloon is currently approved in the USA for coronary indications.”
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.
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 recognised.
Last week it was announced that MedAlliance is to be acquired by Cordis, after the two companies reached agreement for an acquisition which includes an initial investment of US$35 million and upfront closing payment of US$200 million.