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.

Boston Scientific Receives FDA Approval For MR-Conditional Pacing System

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.

The newly-approved family of INGEVITY MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.

Approval of the INGEVITY MRI leads, as well as the full ImageReady System, was based on data from two global clinical trials. The INGEVITY trial, a prospective, non-randomized study, enrolled 1,036 patients and assessed safety, performance and effectiveness of the leads in patients with a single or dual chamber pacemaker. The SAMURAI trial, a prospective, randomized study, enrolled 351 patients and evaluated safety and effectiveness of the ImageReady System for use in patients with a single or dual chamber pacemaker when used in an MRI environment.

The ImageReady System offers automatic daily monitoring via the LATITUDE™ NXT Patient Management System. An increasingly important tool for physicians, automatic daily monitoring has been shown to improve survival in patients with pacemakers1. The LATITUDE NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.

A press release can be found from Boston Scientific webstie following this link.

FDA Approves World's Smallest yet Leadless Pacemaker

Medtronic announced it has received U.S. Food and Drug Administration (FDA) approval of the world's smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

Comparable in size to a large vitamin, the Micra TPS is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to such leads and pocket are eliminated-as are any visible signs of the device. The device responds to patients' activity levels by automatically adjusting therapy.

Micra TPS is the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures available.

The Micra design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS was designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction.

Further info can be found from Medtronic website by clicking this link.

Also in news: St. Jude obtains CE approval for MRI Compatible Nanostim Leadless Pacemaker

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.

St. Jude obtains CE approval for MRI Compatible Nanostim Leadless Pacemaker

St. Jude announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

Product information could be found from this link.

Further news: FDA Approves World's Smallest yet Leadless Pacemaker