Major adverse cardiovascular events

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

Retrieved on: 
Tuesday, November 14, 2023
Cerebrovascular disease, Food, Patient, Major adverse cardiovascular events, Heart failure, FDA, Therapy, BCDA, Guideline, Pharmaceutical industry, Medical device

BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol.

Key Points: 
  • BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol.
  • The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024.
  • Statistical significance (p
  • The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline.

SHL Telemedicine's SmartHeart® Technology to Take Center Stage at Upcoming VPM 2023 Conference

Retrieved on: 
Monday, September 11, 2023
Finance, Hospitals, Clinical Trials, Health Technology, Telemedicine, Virtual Medicine, Professional Services, Cardiology, Biotechnology, Health, SHL, Telehealth, Mayo Clinic, Hospital, VPM, ECG, Multimedia, Major adverse cardiovascular events, MACE, Incidence, Plaque, Moyamoya disease, Gold, Patient, Mortality, Clinical professor, FDA, Imperial College London, Medical device

Both trials relate to the utilization of SHL's patented and FDA cleared SmartHeart® 12-lead ECG technology for remote monitoring of post-MI (heart attack) patients at home.

Key Points: 
  • Both trials relate to the utilization of SHL's patented and FDA cleared SmartHeart® 12-lead ECG technology for remote monitoring of post-MI (heart attack) patients at home.
  • "For years now, we have established and proven our technology’s value for Post MI (heart attack) patients, including significant reductions in mortality and readmission rates.
  • The conference will be held virtually on September 18 - 20th, 2023.
  • SHL Telemedicine is proud to be a SILVER level industry supporter of this conference.

Esperion Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, February 21, 2023
Shoulder, Medicaid, Achilles tendon, Pregnancy, Diet, Moyamoya disease, State Administrative Expenses, Atrial fibrillation, MACE, Upper respiratory tract infection, Acceleration, Abdominal pain, PIN, Uric acid, Spasm, Pain, Simvastatin, Medicare, Hosting, Cholesterol, Patient, Pravastatin, Bronchitis, Back pain, Disease, Drug, Anemia, Lactation, Fetus, Sale, Health, Mortality, Cardiology, Gout, Risk, Congress, ESPR, Major adverse cardiovascular events, Treasury, CLEAR, Concentration ratio, Research, Cardiovascular disease, EmblemHealth, Kidney, Rotator cuff, Medical imaging, Pharmaceutical industry, Cryptocurrency, Dietary supplement, Hyperuricemia, Tufts University, Esperies

ANN ARBOR, Mich., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

Key Points: 
  • “I’m proud of the entire organization at Esperion and our ability to deliver on the commitments we made in 2022.
  • The increase for the fourth quarter ended December 31, 2022, is related to increases in net U.S. product revenue and royalty revenue.
  • These decreases reflect savings from the transformative plan implemented in the fourth quarter of 2021.
  • Esperion works hard to make our medicines easy to get, easy to take, and easy to have.

ELANA® Heart Bypass Solution shows promising preliminary results in first-in-human trials

Retrieved on: 
Saturday, October 8, 2022
Excimer laser, News, Time, Stroke, FIH, Infection, Universities and research institutions in Berlin, MACE, Patient, Major adverse cardiovascular events, Cardiac catheterization, Mortality, Technology, Van Tulleken brothers, Coronary artery bypass surgery, Goal, CABG, DRS, Blood, CEO, Safety, Brain, ELANA, Surgeon, Human, MILAN, Pharmaceutical industry, Medical imaging

Results now available for the first 10 patients being treated with the ELANA open heart bypass solution as part of a SAFE-CAB trial.

Key Points: 
  • Results now available for the first 10 patients being treated with the ELANA open heart bypass solution as part of a SAFE-CAB trial.
  • MILAN, Oct. 8, 2022 /PRNewswire/ -- The preliminary results of the first-in-human (FIH) trials for the innovative ELANA Heart Bypass Solution have been unveiled today and look promising.
  • This news marks an important landmark for the ELANA (Excimer Laser Assisted Non-Occlusive Anastomosis) Heart Bypass Solution and its developer, AMT Medical.
  • "A sutureless coronary anastomosis device like the ELANA Heart Bypass Solution could effectively facilitate minimally invasive CABG," he said.

ELANA® Heart Bypass Solution shows promising preliminary results in first-in-human trials

Retrieved on: 
Saturday, October 8, 2022
Excimer laser, News, Time, Stroke, FIH, Infection, Universities and research institutions in Berlin, MACE, Patient, Major adverse cardiovascular events, Cardiac catheterization, Mortality, Technology, Van Tulleken brothers, Coronary artery bypass surgery, Goal, CABG, DRS, Blood, CEO, Safety, Brain, ELANA, Surgeon, Human, MILAN, Pharmaceutical industry, Medical imaging

Results now available for the first 10 patients being treated with the ELANA open heart bypass solution as part of a SAFE-CAB trial.

Key Points: 
  • Results now available for the first 10 patients being treated with the ELANA open heart bypass solution as part of a SAFE-CAB trial.
  • ELANA Heart Bypass Solution shown to be safe and feasible in humans, with all candidates free of Major Adverse Cardiovascular Events (MACE) at post-operative day 30.
  • MILAN, Oct. 8, 2022 /PRNewswire/ -- The preliminary results of the first-in-human (FIH) trials for the innovative ELANA Heart Bypass Solution have been unveiled today and look promising.
  • This news marks an important landmark for the ELANA (Excimer Laser Assisted Non-Occlusive Anastomosis) Heart Bypass Solution and its developer, AMT Medical.

New Meta-Analysis of Patients with Acute Coronary Syndrome Shows Nearly Half of Recurrent Major Adverse Cardiovascular Events at One Year Occur Within the First 90 Days

Retrieved on: 
Sunday, May 16, 2021
Mace, Major adverse cardiovascular events

The findings show that 49 percent of the recurrent major adverse cardiovascular events (MACE) experienced in the first year following an ACS event occurred within the first 90 days.

Key Points: 
  • The findings show that 49 percent of the recurrent major adverse cardiovascular events (MACE) experienced in the first year following an ACS event occurred within the first 90 days.
  • "\nResearchers performed a comprehensive search to collect data from Phase 3 interventional trials on high-risk ACS patients.
  • Pooled rates of recurrent MACE were 4.1 percent (95% CI: 3.0%-5.7%) at 90 days and 8.3 percent (95% CI: 7.1%-9.8%) at 360 days.
  • For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/vita and follow us on Twitter.com/CSLBehring .\n'

Prothena Announces Confirmatory Phase 3 AFFIRM-AL Study of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis under SPA Agreement with FDA

Retrieved on: 
Monday, February 1, 2021
Clinical trials, Medical statistics, Clinical endpoint, Clinical research, Health, Mortality, Major adverse cardiovascular events, Public health, Cardiac Arrhythmia Suppression Trial

This registration-enabling study will be conducted with a primary endpoint of all-cause mortality at p

Key Points: 
  • This registration-enabling study will be conducted with a primary endpoint of all-cause mortality at p
  • Global, multi-center, double-blind, placebo-controlled, 2:1 randomized, time-to-event study expected to enroll approximately 150 newly diagnosed, treatment nave patients with AL amyloidosis categorized as Mayo Stage IV.
  • Significant changes observed on secondary endpoints provided further evidence of clinical benefit in birtamimab-treated Mayo Stage IV patients in VITAL.
  • For more information on AL amyloidosis, please visit the websites of the Amyloidosis Support Groups , The Amyloidosis Research Consortium , and the Amyloidosis Foundation .

VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Cardiovascular Events in Patients with Compromised Renal Function at Baseline in Prespecified and Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at American Society of Nephrolog

Retrieved on: 
Monday, October 26, 2020
Organic compounds, Branches of biology, GABAA receptor positive allosteric modulators, Lipids, Amarin Corporation, Fish products, Cardiology, Lipoproteins, Ethyl eicosapentaenoic acid, Low-density lipoprotein, Cholesterol, Major adverse cardiovascular events

Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health.

Key Points: 
  • Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health.
  • Amarins lead product, VASCEPA (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates.
  • Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patients risk for cardiovascular events, such as heart attack, stroke or death.
  • Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

Trulicity® (dulaglutide) is now indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the risk of non-fatal stroke in adults with type 2 diabetes mellitus who have multiple cardiovascular risk factors or established cardiovasc

Retrieved on: 
Tuesday, September 22, 2020
RTT, Chemical compounds, Cardiovascular disease, Stroke, Organic compounds, Major adverse cardiovascular events, Canagliflozin

The new indication reflects the differentiated patient population of REWIND, the Trulicity cardiovascular outcomes trial.

Key Points: 
  • The new indication reflects the differentiated patient population of REWIND, the Trulicity cardiovascular outcomes trial.
  • The study consisted primarily of people with multiple cardiovascular risk factors without established cardiovascular disease.
  • REWIND showed a significant risk reduction in MACE-3, a composite endpoint of nonfatal myocardial infarction (heart attack), non-fatal stroke or CV death.
  • Trulicitys new indication to reduce the risk of non-fatal stroke in these patients will provide physicians with an important tool for type 2 diabetes care.

Amarin Supports Latest Clinical Research Evaluating VASCEPA® (Icosapent Ethyl) in Patients with Persistent Cardiovascular Risk Presented at ESC Congress 2020, the Annual Meeting of the European Society of Cardiology

Retrieved on: 
Tuesday, September 1, 2020
Clinical research, Health, Medicine, Articles, Fish products, Clinical trials, Biochemistry, Ethyl eicosapentaenoic acid, Polyolefins, Statin, Major adverse cardiovascular events, Clinical endpoint

The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo.

Key Points: 
  • The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo.
  • The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p=0.053).
  • VASCEPA is the first and only agent studied on top of statin therapy reported to exhibit coronary plaque regression in hypertriglyceridemic patients.
  • Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below: