MedAlliance announced that its SELUTION SLR sirolimus-eluting balloon has secured conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for initiating a clinical trial for the treatment of coronary de novo lesions.
SELUTION SLR (Sustained Limus Release) is said to provide a controlled sustained drug release (DES).
With the latest approval, the Swiss medical technology firm will start its clinical trial for which the enrolment will take place in the US within the next few months.
The regulatory milestone in the US follows the company’s first IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications, which was granted in May 2022.
MedAlliance chairman and CEO Jeffrey Jump said: “Coronary de novo lesions are the largest potential opportunity for use of DEB’s: the data has shown clearly that DES don’t work well in small vessels, long, or bifurcated lesions or in patients with diabetes or risk of high bleeding complications.
“These patients represent 60% of all patients currently treated with DES, who may now benefit from this exciting new DEB technology.”
MedAlliance has enrolled more than 800 patients out of the 3,326 anticipated participants in the coronary de novo randomised controlled study that will compare SELUTION SLR against any limus drug-eluting stent (DES).
The aim of the study is to prove the superiority of the SELUTION SLR drug-eluting balloon (DEB) over DES in coronary de novo artery disease. This is the largest DEB study that has ever been started and has the potential to change medical practice, where metal stents have been the standard of care for more than three decades, the Swiss medical technology maker claimed.
In February 2020, SELUTION SLR obtained CE Mark Approval for the treatment of peripheral artery disease and the same for coronary artery disease treatment in May 2020.
MedAlliance’s DEB technology consists of MicroReservoirs which contain a mixture of biodegradable polymer and the anti-restenotic medication sirolimus that has been coated on the surface of an angioplasty balloon.
