FDA approves Medtronic’s Amplia, Complia MRI-safe CRT-Ds

Medtronic (NYSE:MDT) today claimed title to being to only company with cardiac resynchronization therapy defibrillators approved by the FDA for MRI scans. The Fridley, Minn.-based medical device giant said the FDA approved its Amplia and Complia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to have the heart failure devices on the market “in the coming months,” according to a press release. “With FDA approval of Amplia MRI and Compia MRI, Medtronic continues to lead the market in MR-conditional implantable cardiac devices, bringing greater access to patients that need this vital diagnostic test to identify other potential life-threatening diseases,” heart failure general manager Dr. David Steinhaus said in prepared remarks. “Medtronic is committed to continuing to develop innovative technologies that offer physicians a wide range of technology options to help them improve outcomes for heart failure patients.” “What’s clear from the data and my own personal experience is that a large majority of CRT-D patients will likely need an MRI at some point. Now that CRT-D MRI devices are approved, patients can receive an MRI in a straightforward manner,” added Dr. Rod Gimbel of Case Western Reserve University. “This is a significant development for heart failure patients with CRT-D therapy.” The approval marks the 3rd ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

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CONCLUSIONS: Triage-HF effectively stratified Japanese patients at risk of HF-related hospitalization. PMID: 32448844 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
ConclusionsBoth typical LBBB and LBBB ‐like pattern might be associated with constant activation sequence regardless of etiology and scar localization. Activation initiation in RV apex, not LV activation sequence can be surrogate for left axis deviation. CRT caused inter‐ and intraventricular LV resynchronization without significant ly changed RV activation sequence and duration.This article is protected by copyright. All rights reserved
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: DEVICES Source Type: research
Conclusions. Patients in AF or SR undergoing CRT demonstrated distinct benefits from device implantation and from HIIT as an adjunctive therapeutic strategy. This suggests that both mainstay and adjunctive therapeutics may need to be managed differently in patients in AF and SR. PMID: 31221002 [PubMed - as supplied by publisher]
Source: Scandinavian Cardiovascular Journal - Category: Cardiology Tags: Scand Cardiovasc J Source Type: research
Cardiac resynchronization therapy (CRT) devices are implanted into heart failure patients to try to improve the efficiency of the heart. How well the therapy ends up working depends very much on the positioning of the electrodes of the leads that str...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiology Radiology Source Type: blogs
Yolanda Benito1, Pablo Martinez-Legazpi1*, Lorenzo Rossini2, Candelas Pérez del Villar1, Raquel Yotti1, Yolanda Martín Peinador3, Daniel Rodríguez-Pérez4, M. Mar Desco4, Constancio Medrano1, Jose Carlos Antoranz4, Francisco Fernández-Avilés1, Juan C. del Álamo2,5 and Javier Bermejo1 1Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón and CIBERCV, Madrid, Spain 2Department of Mechanical and Aerospace ...
Source: Frontiers in Physiology - Category: Physiology Source Type: research
AbstractNoninvasive imaging modalities offer the possibility to dynamically evaluate cardiac motion during the cardiac cycle by means of ECG-gated acquisitions. Such motion characterization along with orientation, segmentation preprocessing, and ultimately, phase analysis, can provide quantitative estimates of ventricular mechanical synchrony. Current evidence on the role of mechanical synchrony evaluation is mainly available for echocardiography and gated single-photon emission computed tomography, but less is known about the utilization of gated positron emission tomography (PET). Although data available are sparse, ther...
Source: Journal of Nuclear Cardiology - Category: Nuclear Medicine Source Type: research
Authors: Perge P, Boros AM, Zima E, Gellér L, Merkely B, Széplaki G Abstract OBJECTIVES: Changes in the levels of serum creatinine and N-terminal of prohormone brain natriuretic peptide (NT-proBNP) are useful risk markers after cardiac resynchronization therapy (CRT). The diagnostic value of changes in serum uric acid levels has been established in chronic heart failure, but no data are available on the prognostic value of hyperuricemia in a CRT population. DESIGN: We measured markers of renal function [creatinine, blood urea nitrogen (BUN) and uric acid] and NT-proBNP levels of 129 heart failure ...
Source: Scandinavian Cardiovascular Journal - Category: Cardiology Tags: Scand Cardiovasc J Source Type: research
CONCLUSION: cQLV is a simple measure that can identify a vulnerable cohort of CRT patients at increased risk for atrial tachyarrhythmias, and hence can predict reverse remodeling and clinical response to CRT treatment. PMID: 30570402 [PubMed - as supplied by publisher]
Source: Scandinavian Cardiovascular Journal - Category: Cardiology Tags: Scand Cardiovasc J Source Type: research
CONCLUSION: In this long-term follow-up in patients with atrial fibrillation treated with AVJ ablation and pacing, indication, choice of pacing system, and morbidity differed but there were no sex differences regarding survival or primary cause of death found. The main factor influencing survival was age at the time of ablation. Women less often received treatment with ICD and/or CRT when indication was present compared with men. PMID: 29537317 [PubMed - as supplied by publisher]
Source: Scandinavian Cardiovascular Journal - Category: Cardiology Tags: Scand Cardiovasc J Source Type: research
FDA approved Medtronic's Azure pacemakers, which feature the company's new BlueSync technology to protect patients from having their device hacked. The BlueSync technology is also now available with the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps), the company said. BlueSync is intended to enable more secure wireless remote monitoring via Medtronic's CareLink Network, by limiting access to the device functionality and also by protecting patient data. Connected medical devices like pacemakers add value to patient care by enabling remote patient monito...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Cardiovascular Source Type: news
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