InSeal Medical has reported that it has successfully treated three patients using its investigational intravascular large bore puncture closure device.
Two patients underwent full percutaneous transcatheter aortic valve replacement (TAVR) using an 18 French-sized large bore catheter.
The third patient underwent percutaneous endo-vascular aneurysm repair (EVAR) using a 21 French-sized large bore catheter.
In all three procedures, patients received the experimental InSeal Medical percutaneous vascular closure device.
The study showed that the InSeal closure device achieved a complete acute sealing in each patient with no further bleeding or hematoma at the access site.
InSeal Medical CEO Avi Penner said the feasibility study is an important milestone for the company, and the data will be included in the clinical evidence required to support a CE approval of the InSeal vascular closure device expected in 2012.