Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in U.S.

Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool. The devices are approved by the FDA for conditional use in an MRI environment, the company reported. Boston Scientific’s HeartLogic diagnostic warns doctors of worsening heart failure, collecting data from sensors monitoring heart sounds, thoracic impedance, heart rate and activity and respiration rate and volume. The company touted its alert system as the first and only of its kind in an implantable device with an observed sensitivity of 70% and the ability to provide weeks of advance notice. “The HeartLogic Diagnostic provides physicians the ability to pivot from reactive heart failure treatment to proactive care with a goal of improving patient outcomes and reducing heart failure-related hospitalizations,” Dr. Kenneth Stein, SVP &CMO of Boston Scientific’s rhythm management and global health policy unit, said in prepared remarks. “We believe the new features included in this family of devices offer physicians an unprecedented level of confidence when caring for patients with heart failure.” The CRT-Ds in the Resonate portfolio also feature SmartCRT technology, the company reported, which allows doctors to customize where, when and how to pace the lower chambers of the heart. Boston Scientific has started recruiting patie...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Boston Scientific Source Type: news

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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
Boston Scientific won approval from the FDA and is launching its Resonate line of implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The implants include the firm’s HeartLo...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiology Medicine Source Type: blogs
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
Medtronic (NYSE:MDT) said today its Medtronic Canada subsidiary received Health Canada approval for its line of MRI-conditional cardiac resynchronization therapy defibrillators, touting them as the 1st MRI CRT-Ds cleared in the region. With the new clearance, Fridley, Minn.-based Medtronic’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems, which are currently available in the region, are cleared for MRI scans of any part of the body without positioning restrictions. Both newly cleared devices can be paired with the company’s Attain Performa MRI SureScan quadripolar leads, Med...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices 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
Millions of people experience heart rhythm disturbances in their lifetime. This has propelled cardiac electrophysiology to become one of the most innovative fields in medicine today. BIOTRONIK, a privately owned, global company with headquarters...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiology Exclusive Source Type: blogs
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