MediValve, a portfolio company of The Trendlines Group, has obtained CE Mark approval for its acWire guidewire, a new device intended to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional cardiovascular procedures.
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.