DSMB agrees to continue study after 5th patient review | Jan 2021
Start pilot clinical study prophylactic sac filling | Feb 2021
TripleMed realized the first clinical Milestone for the type II Endoleak pivotal clinical study: To date 7 patients have been treated successfully with AneuFix, and till now without any complications. The AneuFix procedure demonstrated in these patients to be straightforward and safe, and the AneuFix material could be injected in a controllable manner.
After obtaining METC approval in 2020 and a positive DSMB review for the type II Endoleak study, the pilot clinical study to treat patients with a high risk of developing type II Endoleaks with prophylactic Sac Filling is also started
1st patient treated in typ II Endoleak clinical study | Jul 2020
Thursday July 2nd, the 1st patient in the AneuFix Endoleak type II clinical study was treated in the VU Medical Center in Amsterdam .
The complete Endoleak void could be filled as confirmed by CT scan the next day, and thus a Technical Success. No complications occurred during the procedure. .
Approval type II Endoleak clinical study | Feb 2020
February the METC approval for the type II endoelak study was received, after which the clinical study will start.
CA/EC requests for approvals in Germany and Belgium are ongoing
Company move | Dec 2019
In December TripleMed moved to the new location on the Brightlands Chemelot Campus.
Next to additional office space , the new location contains a R&D lab and ISO7 clean production facilities
With this TripleMed is ready to expand their activities towards commercialization of AneuFix / AneuFill