MediValve, Ltd., has announced that it has received FDA 510(k) clearance for its acWire™ Guidewire, intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices.
MediValve’s acWire is designed to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures. The acWire Guidewire is a single-use, fully disposable medical device utilizing innovative shape-memory alloy technology intended to enable identification of cardiovascular structures utilizing 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 acWire may also function as an alignment tool by providing a reference plane of anatomical structure of interest (i.e., the aortic valve).
MediValve announced CE mark approval of its device earlier this month (Jan 2014).
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.”
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.”
Source: MediValve, PR Newswire