BIOTRONIK Launches New Entovis ProMRI Pacemaker and Safio Lead

Pacemakers Expand Canadian Patients Access to MRI Scanning and Offer Physicians Both Single- and Dual-Chamber Options

Toronto, Canada, (PresseBox) - BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the first implantations of its new ProMRI® pacing system in Canada today. The Entovis pacemaker series and Safio pacing leads are part of the first ProMRI[/url] pacemaker series available nationwide, giving patients access to MRI scans under specific conditions.

The first implantation of the Entovis dual-chamber pacemaker was implanted in a 37-year-old man by Dr. Katia Dyrda, cardiac electrophysiologist at the Montreal Heart Institute, one of the leading cardiology institutes in the world. The first implantation of the single-chamber Entovis was performed by Dr. Gebran Boutros of the Hospital Cité de la Santé, just north of Montreal.

These physicians were able to choose the device offering the most advanced physiological therapy available while giving their patients access to MRI scans as needed. Until recently, cardiac implant patients were denied MRIs due to the strong magnetic fields and radio waves that could negatively influence the devices.

"I was happy to be able to select a ProMRI device for my patient," commented Dr. Boutros after the implantation, "because he is older and may develop comorbodities in the future that require an MRI scan to diagnose properly." This patient is 81 years old with existing atrial fibrillation. Dr. Dyrda added, "Working at a leading cardiology research facility, I have had the opportunity to try out many device and lead pairings over the years, and I appreciate the flexibility and reliability of the Safio S lead."

In addition to MRI compatibility, the Entovis pacemaker series includes unique innovations like Closed Loop Stimulation (CLS), the most advanced physiological rate regulation algorithm available on the market, which responds naturally to patients' physical and mental activity or stress. Vp Suppression and IRSplus minimize unnecessary ventricular pacing in order to lower patients' risk of developing atrial fibrillation and heart failure. BIOTRONIK Home Monitoring® is the only remote patient monitoring system on the market that has both FDA and CE approval to safely replace conventional in-office follow-up and provide early detection of symptomatic and asymptomatic events.

The Safio active fixation leads are MR conditional pacing leads with a flexible distal end, fractal coating and steroid elution to ensure optimal electrical performance and a stable fixation.

"Entovis is a groundbreaking pacemaker series, offering the most advanced therapy on the market, along with remote monitoring and follow-up," said Aaron Miller, Managing Director of BIOTRONIK Canada. "We are very pleased to make this technology available to the thousands of Canadian patients indicated for a pacemaker who now can confidently undergo MRI scans."

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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 200 mm peripheral stent; Orsiro, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter-defibrillators with ProMRI technology.

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