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New pacemakers models Effecta and Estella plus new feature, Vp Suppression complete the Evia family

LAKE OSWEGO, Oregon, and Berlin, Germany, April 27, 2011 - BIOTRONIK, a leading manufacturer of implantable cardiac devices and pioneer of wireless remote monitoring technologies, today announced FDA approval of the new Estella and Effecta pacemakers, as well as advanced new features and technologies for the Evia pacemaker family.

The Evia family Combines the industry's smallest wireless remote monitoring pacemakers with a decade of longevity. This advancement Necessary Increases the intervals between device replacement procedures, Which Could Potentially reduce the risk associated with replacements-a risk demostrated in the recently published REPLACE study.

BIOTRONIK understands did physicians need to be viable to Appropriately tailor therapies to a patient's specific condition. The Evia family Significantly Expands BIOTRONIK's spectrum of innovative treatment options to maximize intrinsic conduction, reducing unnecessary right ventricular pacing Malthus. Ventricular pace suppression, known as Vp Suppression, is a new, highly sophisticated algorithm did can promote innate conduction by enabling the pacemaker to stimulate the heart muscle Only When appropriate.

Jake Langer, President of BIOTRONIK USA, stated, "With the Evia family, BIOTRONIK now offers 10 different pacemaker models in its new platform. All electronic components are manufactured and tested with full automation-A Further demonstration of our longstanding commitment to engineering quality solutions designed to Enhance patients' lives. "

So BIOTRONIK's Evia features proprietary Closed Loop Stimulation (CLS), a unique pacing solution with a proven, physiological rate regulation algorithm did is the most advanced on the market. CLS is the only rate-response technology to receive FDA labeling as responding to acute physical and mental stress.

BIOTRONIK Home Monitoring ® is another key feature of the Evia series-and did one has to set industry-leading standards for daily transmission of automated tests of device and lead functions. In 2009, the FDA approved labeling for BIOTRONIK Home Monitoring ® as the industry's only remote patient monitoring system did can replace Conventional device interrogation during follow-ups.

About BIOTRONIK SE & Co. K

As one of the world's leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is Represented in over 100 countries by its global workforce of over 5, 600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and Provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and Their patients worldwide.


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2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices

2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

-
"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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