Medtronic Earns CE Mark Approval For Full Line OF MRI-Safe CRT-D Devices

Medtronic has received CEMark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available. The Claria MRIQuad CRT-D SureScan, Amplia MRI(TM)Quad CRT-D SureScanand Compia MRIQuad CRT-D SureScansystemsare approved for MRI scans without positioning restrictions.
Source: Medical Design Online News - Category: Medical Equipment Source Type: news

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Publication date: Available online 9 July 2019Source: European Journal of RadiologyAuthor(s): Christoph Schukro, Stefan B. PuchnerAbstractPurposeLow-field magnetic resonance imaging (MRI), i.e. MRI with a static magnetic field strength
Source: European Journal of Radiology - Category: Radiology Source Type: research
The Centers for Medicare &Medicaid Services have finalized a plan that will cover magnetic resonance imaging scans for patients with implanted cardiac devices, including pacemakers, cardioverter defibrillators and cardiac resynchronization therapy devices, according to a MedPage Today report. The finalized decision, which was released in January, will allow Medicare patients with MR-conditional devices to have their MRI scans covered by the national healthcare program. Patients with non-MR-conditional devices will also be reimbursed, but only when the MRI machine is 1.5 Tesla or less in normal operating mode, according...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Imaging Wall Street Beat Centers for Medicare and Medicaid Services (CMS) Source Type: news
The Centers for Medicare &Medicaid Services is thinking about extending coverage for magnetic resonance imaging scans to patients with cardiac rhythm management devices after reviewing studies showing that MRI scans are safe. If finalized the decision would allow Medicare patients with implanted MR-conditional devices such as pacemakers or defibrillators to have their MRI scans covered by the national healthcare program. “We propose that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (...
Source: Mass Device - Category: Medical Devices Authors: Tags: Wall Street Beat Cardiac Rhythm Management Centers for Medicare and Medicaid Services (CMS) Source Type: news
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers. The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The leads also feature a side-helix designed to be fixated in veins of various sizes, the company said. Medtronic said it has initiated a limited European launch, with the 1st commercial implants recently performed at Bergen, Norway’s Haukeland U...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news
Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US. The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity in the atrium, as the system itself provides the necessary atrial signal information. Atrial diagnostics are used for the early detection of supraventricular tachycardia, atrial fibrillation and atrial ventricular synchronization. “When treating heart failure p...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Final FDA rules clarify adverse event reporting for contract manufacturers The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its Claria MRI quad cardiac resynchronization therapy defibrillator for magnetic resonance imaging scans at both 1.5 and 3 Tesla. “The Claria MRI CRT-D is our latest innovation to help improve patients’ response to CRT, establishing a new level of personalized care,” heart failure GM Dr. David Steinhaus said in prepared remarks. “And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world.” “Until now,...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. First patient receives Pixium bionic vision implant Pixium Vision said today that the 1st patient in the UK was implanted with its IRIS II bionic vision system. The epi-retinal implant has 150 electrodes and a bio-inspired came...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union to add magnetic resonance imaging conditional labeling to its Quadra Allure MP cardiac resynchonization therapy pacemaker. The company’s Quadra Allure MP CRT-P is now cleared as operable with diagnostic MRI scans of up to 1.5 Tesla, the St. Paul, Minn.-based company said. “The Quadra Allure MP is the only CRT-P with MultiPoint Pacing technology, MRI full-body labeling, and more clinical options to treat patients who don’t respond to initial pacing therapy. This new technology allows patients who have heart failu...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news
Biotronik said yesterday it launched its Ilivia magnetic resonance imaging-safe implantable cardioverter defibrillator in Japan. The Berlin-based comapny said the Ilivia device features both its ProMRI technology and its MRI AutoDetect feature which automatially recognizes when the user is in an MRI environment and switches to MRI mode. The device then switches back to normal functionality when MRI fields are no longer detected. “It’s only recently that MRI conditional devices have become the gold standard in CIEDs. These devices have seen continuous improvements, with the latest being the MRI AutoDetect functi...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Cardiac Implants Cardiovascular Biotronik Source Type: news
More News: Cardiac Resynchronization Therapy | Medical Devices | MRI Scan | PET Scan