CE Mark Approval Granted for MediValve's acWire Guidewire

January 8, 2014—MediValve, Ltd. (Kibbutz Hama'Apil, Israel) announced that the company's acWire guidewire has received CE Mark approval. The acWire is intended to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional cardiovascular procedures. The acWire device is specifically intended for implantation plane acquisition during transcatheter aortic valve replacement procedures using fluoroscopic imaging.

MediValve advised that it has completed filing a premarket notification application for 510(k) clearance with the US Food and Drug Administration for the acWire.

According to the company, the MediValve acWire guidewire is a single-use, fully disposable medical device utilizing innovative shape-memory alloy technology intended to enable identification of cardiovascular structures using existing imaging methods. 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 employs methods and techniques currently used by interventional cardiologists to access the cardiovascular system.

In the company's press release, Gad Keren, MD, Chairman of the Department of Cardiology at Tel-Aviv University's Sackler School of Medicine, commented, “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 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.”