EmStop has announced the completion of the CAPTURE-1 early feasibility clinical trial assessing the safety and performance of the EmStop embolic protection system.
The device is currently being investigated for use as an embolic protection device to capture and remove thrombus during transcatheter aortic valve implantation (TAVI) procedures. This investigatory study was a prospective, multicentre, single armed clinical trial.
A total of 15 subjects underwent treatment with a currently marketed TAVI device and the EmStop system and were evaluated under the approved clinical protocol.
“The successful completion of the CAPTURE-1 clinical trial marks yet another important milestone in the development and clinical understanding of this novel embolic protection technology,” said Phil Ebeling, EmStop president and CEO. “I am thankful for the many healthcare professionals and the entire EmStop team who have supported the advancement of this platform technology.”
In addition to submitting the CAPTURE-1 results for regulatory review, EmStop is looking ahead toward future data publication and the initiation of additional clinical trials based on the totality of these results, the company says in a press release.
“Stroke is a well-known and feared complication of TAVI,” said Michael Chenier (Mission Hospital, Asheville, USA), CAPTURE-I primary investigator. “EmStop offers patients a potential alternative to reduce the likelihood of stroke and other embolic events. Due to the novel integrated filter design, physicians can perform TAVI, and potentially other procedures, while providing patients complete embolic protection and without loss of procedural efficiency or requiring additional vascular access.”
EmStop, currently under active clinical investigation, is designed to provide full cerebral protection for left-hearted catheterisation procedures.
