|By Business Wire||
|July 8, 2014 09:35 AM EDT||
BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the first device patients to undergo full-body magnetic resonance imaging (MRI) scans in the United States have been implanted with the BIOTRONIK DX System. The first investigational scan occurred on Monday, July 7, 2014 at St. Mary Medical Center in Langhorne, Pennsylvania.
The unique BIOTRONIK DX implantable cardioverter defibrillator (ICD) system is the first and only defibrillator system to provide physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and advanced proven shock reduction algorithms, with only a single lead. BIOTRONIK introduced DX technology to the U.S. in 2013.
“In most cases, it’s difficult for electrophysiologists to accurately predict whether their patients will require diagnostic procedures like MRI in the future,” said Dr. Rafael E. Pena, FACC, The Arrhythmia Institute, Newtown, Pennsylvania, who performed the ICD implant on the first patient to undergo a full-body MRI scan at St. Mary Medical Center. “Implanting ICDs with the option for MRI allows me to expand their access to this technology when they need it.”
“Frequently, patients with defibrillators need diagnostic imaging with MRI, and until now the safety of MRI imaging in those patients was questioned,” said Thomas Crawford, MD, Assistant Professor, University of Michigan Health System, and a principal investigator of the ProMRI® study. “MRI Conditional defibrillators are a major advance in cardiac devices.”
The BIOTRONIK ProMRI® study consists of a series of ground-breaking MRI compatibility trials. Phase A resulted in FDA approval of Entovis pacemaker systems for MRI scans with an exclusion zone. Phase B expanded the trial for pacemakers with full-body scans, including cardiac and thoracic spinal scans, and is nearing completion. Now, Phase C incorporates Iforia ICD systems into the list of devices being investigated for full-body MRI scans, including the DX system.
These first U.S. ICD patients receiving full-body scans are among several hundred who are already included in the ongoing study. The Food and Drug Administration (FDA) approved the ProMRI® study expansion to full-body scans for Iforia ICD and DX device systems on May 21, 2014.
Until recently, patients with a pacemaker or ICD were denied MRI scans. The strong forces applied during an MRI scan could negatively affect both implanted device and patient, usually contraindicating MRIs for pacemaker and ICD patients. With its ProMRI® technology, BIOTRONIK has developed a solution to give all cardiac rhythm patients access to MRI scanning. Investigational full-body scans for DX systems are the next step in expanding U.S. patient access to MRIs.
The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.
One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world’s first 4 F-compatible 200mm peripheral stent*; Orsiro, the industry’s first hybrid drug-eluting stent*; and the world’s first implantable cardioverter-defibrillators with ProMRI® technology*.
* Investigational Device: Limited by U.S. law to investigational use.
For more information, visit: www.biotronik.com
The Internet of Things 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 and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and ...
Dec. 5, 2016 09:29 AM EST
Application transformation and DevOps practices are two sides of the same coin. Enterprises that want to capture value faster, need to deliver value faster – time value of money principle. To do that enterprises need to build cloud-native apps as microservices by empowering teams to build, ship, and run in production. In his session at @DevOpsSummit at 19th Cloud Expo, Neil Gehani, senior product manager at HPE, discussed what every business should plan for how to structure their teams to delive...
Dec. 5, 2016 09:15 AM EST Reads: 1,408
"Venafi has a platform that allows you to manage, centralize and automate the complete life cycle of keys and certificates within the organization," explained Gina Osmond, Sr. Field Marketing Manager at Venafi, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 09:15 AM EST Reads: 873
"We are a modern development application platform and we have a suite of products that allow you to application release automation, we do version control, and we do application life cycle management," explained Flint Brenton, CEO of CollabNet, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 08:45 AM EST Reads: 795
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 5, 2016 07:30 AM EST Reads: 7,040
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band-aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It does...
Dec. 5, 2016 07:30 AM EST Reads: 978
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web ...
Dec. 5, 2016 07:15 AM EST Reads: 1,252
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, Phil Hombledal, Solution Architect at CollabNet, discussed how customers are able to achieve a level of transparency that e...
Dec. 5, 2016 06:45 AM EST Reads: 979
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 5, 2016 06:45 AM EST Reads: 1,793
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Dec. 5, 2016 06:45 AM EST Reads: 1,594
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 06:30 AM EST Reads: 731
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Dec. 5, 2016 06:15 AM EST Reads: 895
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...
Dec. 5, 2016 06:00 AM EST Reads: 1,678
Kubernetes is a new and revolutionary open-sourced system for managing containers across multiple hosts in a cluster. Ansible is a simple IT automation tool for just about any requirement for reproducible environments. In his session at @DevOpsSummit at 18th Cloud Expo, Patrick Galbraith, a principal engineer at HPE, discussed how to build a fully functional Kubernetes cluster on a number of virtual machines or bare-metal hosts. Also included will be a brief demonstration of running a Galera MyS...
Dec. 5, 2016 04:30 AM EST Reads: 5,225
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
Dec. 5, 2016 04:15 AM EST Reads: 1,617