|By PR Newswire||
|January 8, 2014 06:00 AM EST||
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, 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, 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," formerly EC mark) 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.
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.
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
For Further Information, Contact:
Bill Edelman, Chairman of the Board
SOURCE MediValve, Ltd.
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Jan. 20, 2017 12:45 AM EST Reads: 2,810
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captur...
Jan. 20, 2017 12:45 AM EST Reads: 2,863
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, discussed the impact of technology on identity. Sho...
Jan. 20, 2017 12:45 AM EST Reads: 4,102
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jan. 20, 2017 12:00 AM EST Reads: 6,327
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Jan. 19, 2017 11:45 PM EST Reads: 9,911
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jan. 19, 2017 09:45 PM EST Reads: 6,815
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Jan. 19, 2017 09:45 PM EST Reads: 7,696
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 19, 2017 09:00 PM EST Reads: 4,555
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
Jan. 19, 2017 08:45 PM EST Reads: 5,387
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus o...
Jan. 19, 2017 07:30 PM EST Reads: 4,237
Providing secure, mobile access to sensitive data sets is a critical element in realizing the full potential of cloud computing. However, large data caches remain inaccessible to edge devices for reasons of security, size, format or limited viewing capabilities. Medical imaging, computer aided design and seismic interpretation are just a few examples of industries facing this challenge. Rather than fighting for incremental gains by pulling these datasets to edge devices, we need to embrace the i...
Jan. 19, 2017 05:30 PM EST Reads: 3,642
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Jan. 19, 2017 05:15 PM EST Reads: 3,113
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 19, 2017 05:15 PM EST Reads: 1,342
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Jan. 19, 2017 04:45 PM EST Reads: 3,771
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Jan. 19, 2017 04:45 PM EST Reads: 3,492