Rapid Medical has announced that the final patient has been enrolled in SUCCESS—a US Food and Drug Administration (FDA) post-market surveillance study assessing the safety and performance of the company’s Comaneci embolisation assist device in the USA.
The final patient was treated by Lee Birnbaum (University of Texas Health Science Center [UTHSC] at San Antonio, USA), as per a recent social media post from Rapid Medical. This addition brings the study to 90 patient enrolments across 17 US sites.
“This is a significant milestone for our clinical trial and an important achievement for patients, trial investigators, and our company,” said James Romero, president, Americas, Rapid Medical.
National principal investigators for the SUCCESS study—which started in November 2020—include Ricardo Hanel (Baptist Neurological Institute, Jacksonville, USA) and Jason Davies (University at Buffalo Neurosurgery [UBNS], Buffalo, USA).
Rapid Medical’s Comaneci technology is indicated for use in the neurovasculature as a temporary endovascular device intended to assist in the coil embolisation of wide-necked intracranial aneurysms with a neck width ≤10mm.