TripleMed BV recently announced an enrolment update regarding the pivotal clinical study of the company’s AneuFix product for the treatment of type II endoleaks.
According to a TripleMed press release, 13 patients have been successfully treated with AneuFix without any major complications. The company plans to enrol a total of 25 patients across six hospitals in The Netherlands and Belgium.
Earlier this year, the Data Safety Monitoring Board (DSMB) approved continuation of the study based on a review of the data of the first seven patients.
“In these 13 patients, the AneuFix procedure has shown itself to be straightforward and safe, and the AneuFix material could be injected in a very controllable manner. Based on the more than 30 months’ data from two patients treated in the 2018 pilot study, whereby the endoleak is still closed and aneurysm growth has been stopped, we look forward to the long term data of the pivotal study in the coming year,” says Arjan Hoksbergen (Amsterdam UMC, Amsterdam, The Netherlands), coordinating principal investigator for the AneuFix pivotal clinical study.
“We are excited to have reached this milestone and we are looking forward with confidence to the continuation of the study to obtain the data for a successful CE submission early in 2022,” remarks Tjeerd Homsma, CEO of TripleMed.