The acWire™ is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The acWire may also function as an alignment tool by providing a reference plane of anatomical structure of interest (i.e., the aortic valve).

KIBBUTZ HAMA'APIL, Israel. -- MediValve, Ltd., a Trendlines portfolio company, today announced that it has received clearance of a Pre-Marketing Notification Application (510(k)) from the US Food and Drug Administration (FDA) for its 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. The acWire may also function as an alignment tool by providing a reference plane of anatomical structure of interest (i.e., the aortic valve). MediValve previously announced clearance of a CE pre-market application for the acWire.

Assaf Klein, Chief Executive Officer for MediValve, commented, "We are thrilled to have reached the milestone of FDA pre-market clearance for our 510(k) application. In today's challenging regulatory environment it is extremely exciting for a young company to achieve both CE and FDA pre-market clearances in the same month. We anticipate significant clinical interest for this innovative technology. This is the second in a series of regulatory applications as we continue our development of several additional acWire products."

Carlos E. Ruiz, M.D., Ph.D., Professor and Chief of Structural and Congenital Heart Disease at  North Shore-LIJ Hofstra University North Shore Health System and Lenox Hill Hospital of New York, said, "I am impressed with the acWire technology and the promise it holds for positioning diagnostic and interventional devices during heart catheterization procedures. I look forward to evaluating the acWire in our clinic."

Source: MediValve, Ltd.