PubMed · 14214665
The source did not provide an abstract. Follow the original record for more information.
Explore connections, maps & timelines
K E EGENBERG. 1964-11-05. [COLLISION WAVES].. https://pubmed.ncbi.nlm.nih.gov/14214665/
Cite the original work for its findings. Save a collection to share your selection of sources.
KEEP EXPLORING
Explore the source record for details and available documents.
The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia occurs. An atrial or ventricular arrhythmia occurs during a premature contraction or ventricular fibrillation. FDA is reclassifying this device based on new information contained in reclassification petitions regarding the device submitted by the Health Industry Manufacturers Association (HIMA) (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (the FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
Simultaneous electrical stimulation of both ventricles in patients with interventricular conduction disturbance and advanced heart failure improves hemodynamics and results in increased exercise tolerance, quality of life. We have developed a novel technique for the assessment and optimization of resynchronization therapy. Our approach is based on transthoracic dynamic three-dimensional (3D) echocardiography and allows determination of the most delayed contraction site of the left ventricle (LV) together with global LV function data. Our initial results suggest that fast reconstruction of the LV is feasible for the selection of the optimal pacing site and allows identifying LV segments with dyssynchrony.