MediValve, Ltd. Announces Initiation of post-Market Clinical Evaluations of the acWire™ Guidewire at Lenox Hill Hospital (New York)

KIBBUTZ HAMA'APIL, Israel, September 24, 2014 /PRNewswire/ --

The acWire™ is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. 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, Ltd., a Trendlines portfolio company, today announced that it has successfully completed the first two cases of post-market clinical evaluation of its acWire Guidewire^[1],[2],[3]. The acWire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The acWire 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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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."

About Carlos Ruiz, MD 

Dr. Ruiz was born and raised in Barcelona, and completed his medical degree at the University of Barcelona.  He trained at the Mayo Clinic with Dr. Valentin Fuster and the University of Southern California, where he did a Critical Care Fellowship with Dr. Harry Max Weil, and in 1991 was named the Director of the Pediatric and Adult Catheterization Labs at Loma Linda University Medical Center and Children's Hospital.  In 1999 he moved to Chicago, where he was Chief of Pediatric Cardiology at the University of Illinois, Chicago until 2006 when he moved to Lenox Hill Heart and Vascular Institute of New York and New York University in New York City.  He is currently Professor and Chief of Congenital & Structural Heart Disease for North Shore LIJ Health System. Dr. Ruiz is full professor of pediatrics and medicine.  He has served on the editorial board of many prestigious cardiology journals, and has published over 250 manuscripts in peer reviewed journals in addition to many book chapters.

Previous Announcements 

MediValve, Ltd., Announced on January 13, 2014 Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the acWire™ Guidewire.

MediValve previously announced on January 06, 2014 CE^[4] Pre-Marketing clearance for the acWire™ Guidewire.

About the MediValve, Ltd., acWire™ Guidewire 

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.  AcWire is designed to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures.

About Lenox Hill Hospital 

Lenox Hill Hospital, a 652-bed, acute care hospital located on Manhattan's Upper East Side, has earned a national reputation for outstanding patient care and innovative medical and surgical treatments. The hospital is particularly well known for excellence in internal medicine, cardiovascular disease, orthopaedics, sports medicine, otolaryngology/head and neck surgery, and maternal/child health. The Hospital is also a recognized leader in public health education and community outreach.

About MediValve Ltd. 

MediValve, Ltd., was founded in 2010, it is a portfolio company of The Trendlines Group (http://www.trendlines.com). MediValve is developing the acWire Guidewire to facilitate the accurate placement of medical devices in the cardiovascular system during diagnostic and interventional procedures.

About The Trendlines Group 

The Trendlines Group (http://www.trendlines.com) invests in, incubates, and supports early-stage life science companies focused on medical and agricultural technologies through its two Israeli government-franchised business incubators, Trendlines Medical and Trendlines Agtech, and through its in-house invention incubator, Trendlines Labs. The Trendlines portfolio includes 46 companies, with 12 in revenue stage.

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1. acWire received CE Pre-market clearance November 08, 2013

2. acWire received FDA 510(k) Pre-market clearance November 08, 2013

3. Patents pending

4. Following review of a Technical File submission by the Institute for Testing and Certification, Inc ("ITC"). The European pre-market clearance completes the Conformité Européenne, or "European Conformity" ("CE") registration process.

For Further Information:
Bill Edelman, Chairman of the Board
MediValve, Ltd.
+1-781-436-0509
[email protected]
http://www.medivalve.com

SOURCE MediValve, Ltd.