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
DXWorldEXPO LLC, the producer of the world's most influential technology conferences and trade shows has announced the 22nd International CloudEXPO | DXWorldEXPO "Early Bird Registration" is now open. Register for Full Conference "Gold Pass" ▸ Here (Expo Hall ▸ Here)
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
IoT is rapidly becoming mainstream as more and more investments are made into the platforms and technology. As this movement continues to expand and gain momentum it creates a massive wall of noise that can be difficult to sift through. Unfortunately, this inevitably makes IoT less approachable for people to get started with and can hamper efforts to integrate this key technology into your own portfolio. There are so many connected products already in place today with many hundreds more on the h...
"We were founded in 2003 and the way we were founded was about good backup and good disaster recovery for our clients, and for the last 20 years we've been pretty consistent with that," noted Marc Malafronte, Territory Manager at StorageCraft, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Here are the Top 20 Twitter Influencers of the month as determined by the Kcore algorithm, in a range of current topics of interest from #IoT to #DeepLearning. To run a real-time search of a given term in our website and see the current top influencers, click on the topic name. Among the top 20 IoT influencers, ThingsEXPO ranked #14 and CloudEXPO ranked #17.
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
"DivvyCloud as a company set out to help customers automate solutions to the most common cloud problems," noted Jeremy Snyder, VP of Business Development at DivvyCloud, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, described how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launching o...
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant tha...
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
The Jevons Paradox suggests that when technological advances increase efficiency of a resource, it results in an overall increase in consumption. Writing on the increased use of coal as a result of technological improvements, 19th-century economist William Stanley Jevons found that these improvements led to the development of new ways to utilize coal. In his session at 19th Cloud Expo, Mark Thiele, Chief Strategy Officer for Apcera, compared the Jevons Paradox to modern-day enterprise IT, examin...
DXWorldEXPO LLC announced today that All in Mobile, a mobile app development company from Poland, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. All In Mobile is a mobile app development company from Poland. Since 2014, they maintain passion for developing mobile applications for enterprises and startups worldwide.
DXWorldEXPO LLC announced today that ICC-USA, a computer systems integrator and server manufacturing company focused on developing products and product appliances, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City. ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of ...
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
We all know that end users experience the internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices - not doing so will be a path to eventual ...