Israel’s MediValve, Ltd. announced that it has successfully completed the first two cases of post-market clinical evaluation of its acWire Guidewire that were conducted at New York’s Lennox Hill Hospital.
The acWire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. It may also function as an alignment tool by providing a reference plane of anatomical structure of interest (i.e., the aortic valve). The acWire has received FDA 510(k) pre-market clearance as well as CE pre-market clearance.
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The MediValve 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.
Use of acWire employs methods and techniques currently utilized 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. It is designed to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures.
Based at Kibbutz Hama’apil, MediValve, Ltd., was founded in 2010 and is a portfolio company of The Trendlines Group. The company is developing the acWire Guidewire to facilitate the accurate placement of medical devices in the cardiovascular system during diagnostic and interventional procedures.
Assaf Klein, Chief Executive Officer for MediValve, commented, “The MediValve team has been working for the past three years on the acWire Guidewire project. The successful use of the acWire in two procedures on Thursday last week at Lenox Hill has been our most important achievement to date. We anticipate significant clinical interest for this innovative technology.”
Carlos E. Ruiz, M.D., Ph.D., Professor and Chief of Structural and Congenital Heart Disease at Lenox Hill Hospital of New York and North Shore-LIJ Hofstra University North Shore Health System, said, “Based on my initial clinical experience with this device, I am impressed with the acWire technology and the promise it holds for positioning transcatheter aortic valves. I look forward to completing the clinical evaluation of the acWire in our center.”