The company obtained the CE Mark approval following review of a technical file submission by the Institute for Testing and Certification.
The acWire device is specifically designed for implantation plane acquisition, during Trans-Catheter Aortic-Valve Implantation (TAVI) procedures, using fluoroscopic imaging.
MediValve CEO Assaf Klein noted the company is thrilled to have reached the milestone of receiving CE pre-market clearance of the acWire.
"We anticipate significant clinical interest for this innovative technology. This is the first in a series of regulatory applications while we continue our development of several additional acWire products," Klein added.
The company has already filed 510(k) pre-marketing notification application with the US Food and Drug Administration for the acWire.
