MediValve Begins Postmarket Study of the acWire Guidewire

September 24, 2014—MediValve, Ltd. announced the initiation of its postmarket clinical evaluation of the company’s acWire guidewire. The acWire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. MediValve noted that the acWire may also function as an alignment tool by providing a reference plane of an anatomic structure of interest (eg, the aortic valve).

According to MediValve, Carlos E. Ruiz, MD, successfully completed the first two procedures in the postmarket study at Lenox Hill Hospital in New York, New York. Dr. Ruiz is professor and chief of structural and congenital heart disease at Lenox Hill Hospital of New York and North Shore-LIJ Hofstra University North Shore Health System. In the company’s press release, Dr. Ruiz commented, “Based on my initial clinical experience with this device, I am impressed with the acWire technology and the promise it holds for positioning transcatheter aortic valves. I look forward to completing the clinical evaluation of the acWire in our center.”

In January 2014, MediValve announced CE Mark approval for the acWire guidewire. The next week, the company announced US Food and Drug Administration 510(k) clearance.

The MediValve acWire guidewire is a single-use, fully disposable medical device utilizing shape-memory alloy technology intended to enable identification of cardiovascular structures using existing imaging methods. After being 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, advised the company.