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Cardiac Event Articles & Analysis: Older
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The publication also highlighted that low-dose AD04 demonstrated an outstanding safety and tolerability profile compared to placebo, featuring a low occurrence of adverse events (AEs), high medication compliance, and a minimal dropout rate. ...
Dose adjustments are recommended for patients aged 65 years or above and/or at risk of major adverse cardiac events (MACE), VTE or malignancy, namely 100mg once daily dose in patients with RA, which can be escalated to 200mg in case of insufficient disease control. ...
“This highly accurate plaque analysis is the foundation for our next-generation CT-derived fractional flow reserve analysis and provides patients and providers with a personalized measure of risk so that their treatment can be tailored to prevent cardiac events like heart attack and stroke.” Program sessions featuring Elucid’s technology ...
ByElucid
(NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learned algorithms with a proven and trusted ...
In this Roll-in cohort there were no procedure- or device-related major adverse cardiac or neurological events. After 12 months, patients with moderate or severely reduced left ventricular ejection fraction (LVEF) had significantly improved LVEF by 4.69.3 (p=0.008) absolute % as compared to baseline prior to shunt implantation. ...
The CardiAMP Cell Therapy Heart Failure Trial is evaluating the effectiveness of the CardiAMP Cell Therapy System for improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for New York Heart Association (NYHA) Class II and III patients who have heart failure associated with ischemic cardiomyopathy. ...
” The DynamX Bioadaptor is designed to address the continuous major adverse cardiac event rate that occurs with drug-eluting stents (DES) each year without plateau.1,2,3 The rigid design of a DES constrains, or “cages,” natural artery functions, restricting its ability to expand, contract and rotate with each heartbeat, as well as accommodate ...
It is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status. CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders, a first for a ...
Its Makoto Intravascular Imaging System, with accompanying Dualpro IVUS+NIRS catheter, is the only technology on the market that is FDA-cleared for the detection of lipid core plaque (LCP) and the identification of patients and plaques at increased risk of major adverse cardiac events (MACE). Infraredx is a wholly owned subsidiary of the Nipro ...
DuraGraft enhances coronary artery bypass grafting (CABG) surgical outcomes by significantly reducing major adverse cardiac events such as repeat revascularization and myocardial infarction. ...
“Brazil and China represent large and rapidly expanding cardiac surgery markets and the allowances in these countries expand our patent estate for DuraGraft and present tremendous commercialization and licensing opportunities for us,” said David Barthel, Marizyme’s CEO. ...
We are looking forward to bringing these new technologies to the market to serve a unique and unmet need in the chronic kidney and cardiac disease population." About Marizyme, Inc. Marizyme is an integrated life sciences company dedicated to the acquisition, development and commercialization of therapies that minimize mortality and costs in the acute care space. ...
Traggis started working with LightDeck Diagnostics founder Chris Myatt at a previous endeavor, Precision Photonics, a Boulder-based manufacturer of laser optics, in the early 2000s. Originally named MBio Diagnostics, LightDeck began as a “skunkworks effort” inside Precision. “I ended up taking over the reins there at Precision Photonics around the time Chris started focusing ...
There was significant reduction in office Pulse Pressure of 13.3 mmHg in BackBeat CNT treated patients at 6 months vs. control (p Overall, there was a very low rate of major adverse cardiac events (MACE), with no events in the treatment group and two events in the control group (no statistical difference between groups at 6 ...
South Korean artificial intelligence (AI) developer, VUNO Inc. announced today that it has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) for its VUNO Med®–DeepCARS™, an AI medical device for cardiac arrest prediction through vital signs. VUNO Med®–DeepCARS™ is a breakthrough AI-driven medical device that analyzes ...
Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension ...
“Of additional importance is that the rate of adverse cardiac events in these patients was lower during the crossover period as compared to the control period, when patients were not receiving treatment with BackBeat ...
“These data provide evidence of significant long-term reductions in systolic blood pressure with a lower-than-expected rate of major cardiac events when BackBeat CNT is activated for a period of up to two years,” stated Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation. ...
This has been associated with major adverse cardiac events (MACE).1 Long-term studies with DES have shown adverse event rates of 20 percent at five years2 and 40 to 50 percent at 10 years,3 demonstrating that MACE grows without plateau after the first year. ...
This has been shown to (a) maintain the ability for positive adaptive remodeling, (b) restore vessel function, and (c) allow for the vessel’s return toward baseline angulation.1 The bioadaptor is designed to address the major adverse cardiac event (MACE) rate that occurs with drug-eluting stents each year without plateau.2,3,4 The rigid design of a DES ...