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BIOTRONIK announced the first implantation of a pacemaker from the newly EU-approved E-Series of the company’s devices. The Enitra 8 HF-T QP is now pacing a woman with a history of failure and complete heart block who received the device at the Great Western Hospital in Swindon, UK, according to the company.
The pacemaker has an expected 14 year battery lifetime and features an MRI sensor that automatically switches the device into ProMRI mode that limits functionality while the patient is inside the scanner. The Enitra line is also quite small, leaving a less visible mark on the patient’s chest and resulting in improved long-term comfort.
Regarding the first implant, Dr. Paul Foley, Consultant Cardiologist during the procedure, noted, “The anatomy of this patient and the venous access presented a particular challenge, so the small size of Enitra and the quadripolar left ventricular lead were paramount in the success of the procedure. I was also personally very impressed with the size and specifications of the device.”
Boston Scientific won FDA approval for its EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD), as well as retroactive magnetic resonance (MR) conditional labeling for already implanted EMBLEM S-ICDs. The new regulatory decision will allow patients sporting these devices to continue to be protected from cardiac arrest even while inside an MRI machine.
The new system includes SMART Pass technology, which can also be added to existing devices via a software update, that improves the accuracy of shock delivery so it’s only done when necessary. Additionally, the new AF Monitor feature detects atrial fibrillation events and reports those to the patient’s cardiologist for closer inspection.
For Further Information
More on the markets for cardiac rhythm management devices can be found in our upcoming report published by iData entitled US Markets for Cardiac Rhythm Management, which covers the U.S. as a whole, as well as market segments for pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, cardiac lead, external defibrillators, cardiac ablation, diagnostic electrophysiology devices, and electro-cardiograph and cardiac monitoring devices.
The iData series on the market for cardiac rhythm devices also covers the U.S., and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for a US Markets for Cardiac Rhythm Management Devices report brochure and synopsis.
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