The Trendlines Group’s portfolio company MediValve has received CE Mark clearance for its acWire guidewire, to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures.
MediValve received this approval following review of a technical file submission by the Institute for Testing and Certification.
The acWire guidewire is a single-use, fully disposable device utilising shape-memory alloy technology intended to enable identification of cardiovascular structures during standard flouroscopic imaging.
It is designed for use with all currently available trans-catheter aortic-valve implantation (TAVI) systems.
Without changing the standard TAVI implant procedure, acWire provides the cardiologist with a continuous, clear, and precise landmark where to implant the prosthetic valve.
According to the company, the device relies on latest standard methods and techniques that are used by interventional cardiologists to access the cardiovascular system.
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.
acWire has been designed to shorten procedure time, reduce usage of radiation and contrast media, and improve clinical outcomes.
MediValve CEO Assaf Klein said: "We anticipate significant clinical interest for this innovative technology. This is the first in a series of regulatory applications while we continue our development of several additional acWire products."
MediValve has already filed 510(k) application with the US Food and Drug Administration for the acWire system.
Image: The MediValve acWire Guidewire is a single-use, fully disposable medical device. Photo: courtesy of Yaddah.