Click here to close now.




















Welcome!

News Feed Item

FDA Approves BIOTRONIK Entovis Pacemaker System with ProMRI® Technology

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has granted approval for its Entovis pacemaker system with ProMRI® technology. The Entovis system allows patients to undergo Magnetic Resonance Imaging (MRI) scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.

BIOTRONIK Entovis Single-Chamber Pacemaker with ProMRI Technology (Photo: Business Wire)

BIOTRONIK Entovis Single-Chamber Pacemaker with ProMRI Technology (Photo: Business Wire)

Approximately 50,000 single-chamber pacemakers are currently implanted in the U.S. each year; until now, these patients have not been able to access MRI scans. BIOTRONIK is the first company in the U.S. to offer both single- and dual-chamber pacemakers approved for use in an MRI environment. Also, BIOTRONIK is the first company worldwide to offer the current generation of pacing leads with ProMRI® pacemakers. Setrox, including versions released under other names, is the most used lead in MRI pacemakers on the market today with over 850,000 leads sold worldwide.

“With the Entovis longevity and the history of lead reliability, this is a system that will serve a wide variety of pacemaker patients for the foreseeable—and unforeseen—future needs,” said Carleton Nibley, M.D., electrophysiologist at John Muir Medical Center in Concord and Walnut Creek, California, and a participant in the ProMRI® study.

The Entovis system presents advantages over existing pacemakers approved as MR conditional. Patients with approved Entovis pacemakers and leads need only alert radiology staff of their device and the staff will verify the patient meets the criteria to undergo an MRI scan.

Several million patients are currently implanted with pacemaker systems worldwide, and recent studies estimate that a sizeable portion of them will develop a clinical need for an MRI scan during their lifetimes.1,2 MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT), or ultrasound. However, the strong forces applied during MRIs can have a negative effect on the pacing system and have been contraindicated for pacemaker patients in the past.

FDA approval comes only 16 months after the initial clinical study was launched, and five months after the approval of that study’s expansion to include full-body MRI scans. These studies are required by FDA for product evaluation, and are designed to assess the safety and efficacy of BIOTRONIK’s existing single- and dual-chamber Entovis pacemaker systems and Setrox 53 and 60cm leads during MRI scans. These devices are already commercially available in the U.S., but lacked FDA approval for use in the MRI environment.

“The BIOTRONIK Entovis ProMRI® pacemaker system is the latest example of our commitment to excellence and meaningful innovation in supporting patient treatment and quality of life,” said Paul Woodstock, BIOTRONIK Executive Vice President of Sales and Marketing. “We are proud to be able to satisfy the demand for state-of-the-art devices that allow physicians to deliver optimal care to the increasing number of pacemaker patients who may someday need an MRI.”

Entovis devices include BIOTRONIK Home Monitoring® technology, which provides daily monitoring of the patient’s device, and offer the most advanced physiological therapy available via Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to ensure excellent handling and stable fixation, as well as optimal electrical performance.

About BIOTRONIK
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 5,800 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

References:

1 Morgan Stanley, ICD market, 1996–2009.

2 Roguin et al., Europace 2008, 10, 336-346.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Contrary to mainstream media attention, the multiple possibilities of how consumer IoT will transform our everyday lives aren’t the only angle of this headline-gaining trend. There’s a huge opportunity for “industrial IoT” and “Smart Cities” to impact the world in the same capacity – especially during critical situations. For example, a community water dam that needs to release water can leverage embedded critical communications logic to alert the appropriate individuals, on the right device, as...
U.S. companies are desperately trying to recruit and hire skilled software engineers and developers, but there is simply not enough quality talent to go around. Tiempo Development is a nearshore software development company. Our headquarters are in AZ, but we are a pioneer and leader in outsourcing to Mexico, based on our three software development centers there. We have a proven process and we are experts at providing our customers with powerful solutions. We transform ideas into reality.
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
eCube Systems has released NXTmonitor, a full featured application orchestration solution. NXTmonitor, which inherited the code base of NXTminder, has been extended to support multi-discipline processes and will act as a DevOps utility in a heterogeneous enterprise environment. Previously, NXTminder was packaged with NXTera middleware to configure and manage Entera and NXTera RPC servers. “Since we are widening the focus of this solution to DevOps, we felt the need to change the name to NXTmon...
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., will focus on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what...
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, 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. Meanwhile, 94% of enterprises ar...
Moving an existing on-premise infrastructure into the cloud can be a complex and daunting proposition. It is critical to understand the benefits as well as the challenges associated with either a full or hybrid approach. In his session at 17th Cloud Expo, Richard Weiss, Principal Consultant at Pythian, will present a roadmap that can be leveraged by any organization to plan, analyze, evaluate and execute on a cloud migration solution. He will review the five major cloud transformation phases a...
While many app developers are comfortable building apps for the smartphone, there is a whole new world out there. In his session at @ThingsExpo, Narayan Sainaney, Co-founder and CTO of Mojio, will discuss how the business case for connected car apps is growing and, with open platform companies having already done the heavy lifting, there really is no barrier to entry.
SYS-CON Events announced today that the "Second Containers & Microservices Expo" will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Amazon and Google have built software-defined data centers (SDDCs) that deliver massively scalable services with great efficiency. Yet, building SDDCs has proven to be a near impossibility for ‘normal’ companies without hyper-scale resources. In his session at 17th Cloud Expo, David Cauthron, founder and chief executive officer of Nimboxx, will discuss the evolution of virtualization (hardware, application, memory, storage) and how commodity / open source hyper converged infrastructure (HCI) so...
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
Manufacturing connected IoT versions of traditional products requires more than multiple deep technology skills. It also requires a shift in mindset, to realize that connected, sensor-enabled “things” act more like services than what we usually think of as products. In his session at @ThingsExpo, David Friedman, CEO and co-founder of Ayla Networks, will discuss how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the ...
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...