MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval
SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions. This comes less than eight months after the company received its first IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications; as well as occlusive […]