MediValve Receives CE Pre-Market Clearance for acWire Guidewire

MediValve Ltd. has received European pre-market clearance for the acWire Guidewire following a review of a technical file submission by the Institute for Testing and Certification Inc (ITC). The European pre-market clearance completes the Conformité Européenne, or European Conformity (CE) registration process.

The acWire specifically is intended for implantation plane acquisition during Trans-catheter Aortic-Valve Implantation (TAVI) procedures, using fluoroscopic imaging.

Previously, MediValve completed filing a pre-marketing notification 510(k) application with the U.S. Food and Drug Administration for the acWire.

“We are thrilled to have reached the milestone of receiving CE pre-market clearance of the acWire,” said MediValve CEO Assaf Klein. “We anticipate significant clinical interest for this technology. This is the first in a series of regulatory applications while we continue our development of several additional acWire products.”

The MediValve acWire Guidewire is a single-use, fully disposable medical device utilizing shape-memory alloy technology intended to enable identification of cardiovascular structures utilizing existing imaging methods. Use of acWire employs methods and techniques currently utilized by interventional cardiologists to access the cardiovascular system. Once directed to a selected cardiovascular location, acWire is deformable under fluoroscopy to identify a desired specific anatomical landmark for subsequent therapeutic treatment by the clinician. acWire is designed to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures.

“Accurate positioning of interventional medical devices within the cardiovascular system is critical to patient safety and successful clinical outcomes. The acWire technology now being developed by MediValve holds the promise of addressing both critical needs. With an aging population world-wide and an increasing incidence of cardiovascular interventions, the clinical community will look for solutions that increase patient safety and facilitate uniform and consistent clinical results. I look forward to acWire entering the clinic,” said Gad Keren, M.D., chairman of the Department of Cardiology, Tel-Aviv University’s Sackler School of Medicine.

Founded in 2010, MediValve is a portfolio company of The Trendlines Group.