MediValve, a portfolio company of The Trendlines Group, has received 510(k) pre-marketing clearance from the US Food and Drug Administration (FDA) for its acWire guidewire.
The company has designed acWire guidewire for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices.
In addition, the single-use, fully disposable medical device may also be used as an alignment tool by providing a reference plane of anatomical structure of interest (that is, the aortic valve).
The device features shape-memory alloy technology and relies on the latest standard methods and techniques that are used by interventional cardiologists to access the cardiovascular system. It enables identification of cardiovascular structures utilizing existing imaging methods.
Once directed to a selected cardiovascular location, acWire is deformable under fluoroscopy to identify desired specific anatomical landmark for subsequent therapeutic treatment by the clinician.
MediValve CEO Assaf Klein noted the company is thrilled to have reached the milestone of FDA pre-market clearance for its 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," Klein added.
Image: FDA approves 510(k) pre-marketing clearance for MediValve’s acWire guidewire. Photo: Courtesy of MediValve, Ltd.