MediValve, Ltd., Announces CE Clearance for the acWire™ Guidewire
KIBBUTZ HAMA’APIL, Israel, January 8, 2014 -- The acWire Guidewire is intended to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional cardiovascular procedures. The acWire device is specifically intended for implantation plane acquisition, during Trans-Catheter Aortic-Valve Implantation (TAVI) procedures.
MediValve, Ltd., today announced that the company has received European pre-market clearance for the acWire Guidewire[1],[2] 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. The acWire is specifically intended for implantation plane acquisition, during Trans-Catheter Aortic-Valve Implantation (TAVI) procedures, using fluoroscopic imaging.
Previously, MediValve completed filing a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for the acWire.
Assaf Klein, Chief Executive Officer for MediValve commented, “We are thrilled to have reached the milestone of receiving CE pre-market clearance of the acWire. 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.”
Gad Keren, MD[3], Chairman of the Department of Cardiology, Tel-Aviv University’s Sackler School of Medicine, commented, “Accurate positioning of interventional medical devices within the cardiovascular system is critical to patient safety and successful clinical outcomes. The acWire technology now being developed by MediValve holds the promise of addressing both critical needs. With an aging population world-wide and an increasing incidence of cardiovascular interventions, the clinical community will look for solutions that increase patient safety and facilitate uniform and consistent clinical results. I look forward to acWire entering the clinic.”
About Gad Keren, MD
Gad Keren, MD, has been Professor of Cardiology at Tel-Aviv University’s Sackler School of Medicine since 1994. Prof. Keren serves as Head of the Department of Cardiology at the Tel Aviv Medical Center. He served as Medical Director of B-Balloon Ltd., in addition to several other innovative medical device companies. Prof. Keren has held the Chaim Sheba Chair of Cardiology at Tel Aviv University since 2005. Prof. Keren was a research fellow at the National Institute of Health in 1989 and 1990. Prof. Keren has co-authored over 200 original articles, numerous case reports and review articles. He has written numerous patents in the field of cardiovascular therapeutics.
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 the CE Mark
The CE mark (Conformité Européenne, meaning “European Conformity,"[4] formerly EC mark[5]) according to the European Medical Directive (MDD), is a mandatory conformity mark for medical devices placed on the market in the European Economic Area (EEA). With the CE marking on a medical device, the manufacturer ensures that the product conforms to the essential requirements of the applicable EC medical device directives.[6]
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 Trendlines
The Trendlines Group (http://www.trendlines.com) creates and develops companies to improve the human condition, investing in medical device and agricultural technology companies. The Trendlines Group owns two Israel-based business incubators: Trendlines Medical, which invests medical device companies; and Trendlines Agtech, which focuses on agricultural technologies. The Trendlines portfolio includes 60 companies, with 15 that have already brought products to market.
1. This product is not approved for sale in the US.
2. Patents pending.
3. Dr. Keren is a member of the MediValve Board of Directors and the Chairman of the Medical Advisory Board
4. http://ec.europa.eu/enterprise/faq/index_en.htm#09012624859cd715
5. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:en:HTML
6. http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/faq/index_en.htm
For Further Information, Contact:
Bill Edelman, Chairman of the Board
MediValve, Ltd.
+1-(781) 436-0509
bill.edelman@medivalve.com
http://www.medivalve.com
SOURCE MediValve, Ltd.
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