Welcome!

News Feed Item

MediValve, Ltd., Announces CE Clearance for the acWire™ Guidewire

KIBBUTZ HAMA'APIL, Israel, January 8, 2014 /PRNewswire/ --

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
[email protected]

http://www.medivalve.com

SOURCE MediValve, Ltd.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that EastBanc Technologies will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. EastBanc Technologies has been working at the frontier of technology since 1999. Today, the firm provides full-lifecycle software development delivering flexible technology solutions that seamlessly integrate with existing systems – whether on premise or cloud. EastBanc Technologies partners with p...
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, will discuss how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He will discuss how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors...
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
In the rush to compete in the digital age, a successful digital transformation is essential, but many organizations are setting themselves up for failure. There’s a common misconception that the process is just about technology, but it’s not. It’s about your business. It shouldn’t be treated as an isolated IT project; it should be driven by business needs with the committed involvement of a range of stakeholders.
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
In his session at 18th Cloud Expo, Bruce Swann, Senior Product Marketing Manager at Adobe, will discuss how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects). Bruce Swann has more than 15 years of experience working with digital marketing disciplines like web analytics, social med...
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
SYS-CON Events announced today that Isomorphic Software will exhibit at SYS-CON's [email protected] at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, high-productivity enterprise web applications for any device. SmartClient couples the industry’s broadest, deepest UI component set with a java server framework to deliver an end-...
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
How will your company move to the cloud while ensuring a solid security posture? Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is ...