Biotronik pacemakers with MRI sensor CE approved

Biotronik has announced CE approval for its new Edora pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). Edora devices feature the company’s ProMRI® technology, including the MRI AutoDetect sensor. This approval means that BIOTRONIK now offers the industry’s first full portfolio of cardiac devices with MRI sensors. The small-sized Edora pacemakers are also expected to have over 14 years of longevity.




MRI AutoDetect helps to both simplify physician workflow and increase patient safety and quality of life by ensuring the patient’s device is in its MRI safe mode during only the period of the MRI scan itself. When a physician switches on the sensor, the device is calibrated to automatically adapt to an MRI environment, keeping the patient’s device at full functionality until the scan is performed. This can take place up to 14 days after the physician turns the sensor on. This 14-day period represents the longest programmable window for MRI sensors on the market. As soon as the scan concludes, the device restores automatically to full functionality, instead of the current procedure requiring manual reprogramming by the physician. The cardiologist receives a full report via BIOTRONIK Home Monitoring® within 24 hours of the scan.

“MRI compatibility for cardiac devices has been a critical development in helping our patients to have longer, better lives. But there are still logistical challenges to managing workflow between cardiologists and radiologists. MRI AutoDetect will certainly help to simplify those,” commented Dr. Paul Foley, Great Western Hospital, Swindon, United Kingdom. “Meanwhile, reducing the amount of time the device is in MRI mode helps to minimize both the risk to the patient and the impact on their quality of life. This is because the pacemaker functions with all its available features for as long as possible before the scan begins.”

“The MRI AutoDetect feature recently won the Cardiostim Innovation Award for ‘Best Practice Improvement,’ in recognition of our contribution to patient safety and easing physician workflows. With Edora’s approval, we are the first to offer MRI AutoDetect to all device patients, whether they are pacemaker, ICD, or CRT patients,” stated Manuel Ortega, Senior Vice President at BIOTRONIK. “With Home Monitoring and the Closed Loop Stimulation algorithm also onboard, we’re proud to be able to give all patients, whatever device they need, the very best care possible.”

Edora single- and dual-chamber pacemakers currently have CE approval for full-body MRI scans at 1.5T and 3.0T scans with an exclusion zone.

A press release is available on Biotronik website.

St. Jude Launches First US Implants of MultiPoint Pacing

St. Jude received U.S. Food and Drug Administration (FDA) approval of the company’s proprietary, first-to-market MultiPoint™ Pacing technology and today announced the U.S. launch and first U.S. implants of the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). MultiPoint Pacing technology is a revolutionary approach designed for CRT patients who are not responsive to other pacing options.

The first implant took place at Saint Francis Hospital in Hartford, Conn. Speaking about the opportunity, Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut at Saint Francis said, “We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.”

Despite the improvements in patient outcomes seen with quadripolar CRT technology, a small, but important group of patients do not respond optimally to the therapy. Importantly, these “non-responders” to CRT cannot be identified at the time of implant and how effective the therapy will be in addressing an individual patient’s heart failure symptoms can be unpredictable. MultiPoint Pacing technology offers physicians a new set of tools that allow for individualized patient therapy with the goal of optimizing their response to CRT.

St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the United States in 2011 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The Quartet LV lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance; this also reduces the likelihood of costly and invasive lead revision through a second intervention procedure. Adding MultiPoint Pacing technology and additional lead sizes to the quadripolar offerings provides physicians more advanced options to optimize CRT performance, such as improving hemodynamics, resynchronization and reverse remodeling of the heart.

The press release can be found from St. Jude website by clicking here.

St. Jude Announces CE Approval of Quadripolar Pacing Leads

St. Jude announced CE Mark approval and launch of three new Quartet™ left ventricular (LV) leads, offering additional electrode spacing options and one new lead shape. The additional spacing combinations are aimed to more effectively target the individual cardiac anatomies of patients who need support from cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D).

Studies have shown that CRT can improve the quality of life for many patients with heart failure. CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. The addition of MultiPoint Pacing™ technology enables physicians to program a single Quartet LV lead to pace multiple sites on the left side of the heart, giving the clinician more choices to improve patient response to therapy and reducing the likelihood of costly and invasive lead revision through a second intervention procedure.

The newly-approved additional quadripolar lead options are used with next-generation MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left side of the heart and provide physicians a new option for patients who haven’t responded to CRT. The expanded selection of quadripolar pacing leads makes the St. Jude Medical quadripolar lead portfolio the broadest on the market and allows for enhanced individualization of CRT. The new leads are designed based on the company’s first-to-market proven quadripolar LV lead technology and include additional spacing options on two new S-shape and one new double-bend lead designs.

Some of the newly approved products are also magnetic resonance (MR) – conditional, including the Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing. Additionally, physicians will be able to quickly customize therapy using the Auto VectSelect Quartet™ Test, which is designed to automatically guide programming of the most appropriate therapy options available and streamline workflow.