TripleMed’s AneuFix Device for Type II Endoleak Evaluated in Pivotal Study

June 7, 2021—TripleMed BV announced an update to enrollment in the pivotal clinical study of the company’s AneuFix device for the treatment of type II endoleaks of aortic aneurysms. AneuFix is a two-component polymer that is injected into the endoleak, where it forms an elastic implant to stop the endoleak and prevent further growth of the aneurysm.

According to TripleMed, the ANEUFIX for Endoleak Type II Repair pivotal study has enrolled 13 patients who have been successfully treated with AneuFix without any major complications. Earlier in 2021, the study’s Data Safety Monitoring Board approved continuation of the study based on a review of the data of the first seven patients.

The company advised that the study is planned to enroll a total of 25 patients at six hospitals in the Netherlands and Belgium. Arjan Hoksbergen, MD, from Amsterdam University Medical Center in Amsterdam, the Netherlands, serves as coordinating Principal Investigator for the AneuFix pivotal clinical study.

“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,” commented Dr. Hoksbergen in TripleMed’s announcement. “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.”

Tjeerd Homsma, CEO of TripleMed, stated in the press release, “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.”