|[May 07, 2014]
FDA Approves BIOTRONIK Entovis Pacemaker System with ProMRI® Technology
LAKE OSWEGO, Ore. --(Business Wire)--
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)
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
"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 pacemkers 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
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
1 Morgan Stanley, ICD market, 1996-2009.
2 Roguin et al., Europace 2008, 10, 336-346.
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