CE mark clearance for MediValve’s acWire guidewire


MediValve has announced that it has received European pre-market clearance for its acWire guidewire, which completes the CE registration process for the device. The acWire is specifically intended for implantation plane acquisition during transcatheter aortic valve implantation procedures, using fluoroscopic imaging.

The MediValve acWire guidewire, a press release reports, is a single-use, fully disposable medical device using innovative shape-memory alloy technology intended to enable identification of cardiovascular structures using existing imaging methods. Use of acWire employs methods and techniques currently used 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. The device is designed to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures.

Gad Keren, chairman of the department of cardiology, Tel-Aviv University’s Sackler School of Medicine, Israel, comments, “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 ageing population worldwide 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.”