MediValve has obtained 510(k) pre-marketing clearance from the US Food and Drug Administration for its acWire guidewire, intended for use in peripheral vascular and heart catheterisation procedures, to introduce and assist in positioning diagnostic and interventional devices.
MediValve's acWire may also function as an alignment tool by providing a reference plane of anatomical structure of interest.
The acWire guidewire is a single-use, fully disposable medical device utilising shape-memory alloy technology intended to enable identification of cardiovascular structures using existing imaging methods.
It is specifically intended for implantation plane acquisition, during trans-catheter aortic-valve implantation (TAVI) procedures, using fluoroscopic imaging.
acWire identifies exact locations within the cardiovascular system during interventional procures, making it a promising choice for the TAVI interventional procedure.
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 company's acWire promises shorter procedure times, reduced usage of radiation and contrast media, and improved clinical outcomes.
The device relies on latest standard methods and techniques that are used by interventional cardiologists to access the cardiovascular system.
MediValve CEO Assaf Klein said: "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."
Recently, the company also obtained CE Mark approval for the acWire guidewire.
Image: MediValve receives FDA 510(k) approval for acWire guidewire. Photo: courtesy of MediValve, Ltd.