CVD

NewAmsterdam Pharma Enrolls Over 9,000 Patients in Pivotal Phase 3 PREVAIL Global Cardiovascular Outcome Trial Evaluating the Effect of Obicetrapib in Patients with Established Atherosclerotic Cardiovascular Disease

Retrieved on: 
Tuesday, April 9, 2024
Disability, Cardiovascular disease, Myocardial infarction, CVD, Risk, Patient, Stroke, NAMS, History, Mortality, Death, FESC, Moyamoya disease, Phase 3, Monash University, MACE, ASCVD, Hypercholesterolemia, Pharmaceutical industry

Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.

Key Points: 
  • Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.
  • “PREVAIL, our pivotal CVOT, will potentially demonstrate that obicetrapib’s lowering of LDL-C will reduce major adverse cardiac events (“MACE”).
  • The primary objective of the study is to evaluate the effect of obicetrapib compared to placebo on MACE, including cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization.
  • “Despite widespread availability of statin therapies, CVD-related deaths are on the rise, and many patients are not at their risk-based LDL-C goals.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

United States Cardiovascular Devices Market, Size, Share, Forecast 2024-2030 Featuring Abbott Laboratories, Boston Scientific, Edwards Lifesciences, Cardinal Health, Medtronic, GE, J&J, & Siemens - ResearchAndMarkets.com

Retrieved on: 
Monday, April 8, 2024
Health, Medical Devices, Cardiology, Hospital, Cardiac catheterization, Disease, American Heart Association, Stent, Cardiovascular disease, Coronary artery disease, Prevalence, Biotechnology, CVD, ECG, Incidence, Diabetes, Electrocardiography, Public, Research, Mortality, Insight, Death, Risk, Arrhythmia, Diagnosis, Heart failure, CAD, Medical device

Consequently, producers are investing in innovation and developing new cardiovascular devices to satisfy growing healthcare wishes, expanding the increase in the United States cardiovascular devices market.

Key Points: 
  • Consequently, producers are investing in innovation and developing new cardiovascular devices to satisfy growing healthcare wishes, expanding the increase in the United States cardiovascular devices market.
  • Technology is pivotal in employing growth in the United States cardiovascular devices market.
  • Numerous market players actively enforce strategic tasks, propelling an increase in the United States cardiovascular devices market.
  • In the United States cardiovascular devices market, diagnostics and monitoring devices have a significant presence
    The United States cardiovascular device market is broken up by device type into Diagnostics and Monitoring Devices and Therapeutic and Surgical Devices.

LIB Therapeutics Announces Positive Results from LIBerate-HR Study: A 52-Week, Placebo-Controlled Registration-Enabling Trial of Lerodalcibep at Late-Breaking Session at American College of Cardiology 2024

Retrieved on: 
Monday, April 8, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Week, Temperature, Cardiovascular disease, PCSK9, CVD, ADAS, FH, Patient, Travel, Female, Refrigeration, OLE, MBBS, Marketing, European Medicines Agency, American College, Therapy, Liberation, ITT, Safety, Food, ACC, Apolipoprotein B, Apolipoprotein, Pharmaceutical industry

Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks.

Key Points: 
  • Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks.
  • Of 478 participants in the base LIBerate-HeFH trial, 421 (88%) continued into the OLE trial: 281 patients on Lerodalcibep and 140 on placebo.
  • All participants received open-label Lerodalcibep 300 mg in a subcutaneous 1.2 mL once-monthly dose starting immediately upon completion of the base trial.
  • After 48 weeks of OLE treatment, mean % LDL-C reductions with Lerodalcibep from baseline in the base trial was 48.5% (ITT population).

Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24

Retrieved on: 
Monday, March 25, 2024
Health, Tablet, CVD, Bempedoic acid, Risk, Patient, CLEAR, Esperies, Ezetimibe, Safety, ATP, Pharmaceutical industry

At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Key Points: 
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there.
  • Because when it comes to high cholesterol, getting to goal is not optional.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD

Retrieved on: 
Tuesday, March 12, 2024
Consensus, Moyamoya disease, Cardiovascular disease, Myocardial infarction, Dyslipidemia, CVD, Cardiology, Risk, Patient, Apolipoprotein B, Consensus decision-making, Stroke, NAMS, ASCVD, Plaque, Artery, Diet, Cleveland Clinic, Ezetimibe, Clinical trial, Safety, FDC, Apolipoprotein, Genetic disorder, Physician, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.

Key Points: 
  • The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk.
  • The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo.
  • NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl.
  • Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

GE HealthCare Introduces Caption AI on Vscan Air SL Wireless Handheld Ultrasound System to Help More Clinicians Capture Diagnostic-Quality Cardiac Images

Retrieved on: 
Wednesday, April 3, 2024
Technology, Mobile, Wireless, Health, Apps, Applications, Radiology, Professional Services, Artificial Intelligence, Medical Devices, Software, Hospitals, Data Analytics, Health Technology, Data Management, Cardiology, Diagnosis, Cardiovascular disease, Prevalence, CVD, Intelligence, Patient, Acquisition, Death, Master of Science, LVEF, Caption, American College, GE HealthCare, Heart, Atrial fibrillation, ACC, Medical imaging

GE HealthCare (Nasdaq: GEHC) today announced the launch of Caption AI artificial intelligence (AI)-driven software for rapid cardiac assessments at the point of care on Vscan Air SL.

Key Points: 
  • GE HealthCare (Nasdaq: GEHC) today announced the launch of Caption AI artificial intelligence (AI)-driven software for rapid cardiac assessments at the point of care on Vscan Air SL.
  • Now, with Caption AI technology, clinicians using Vscan Air SL handheld ultrasound will have access to real-time, step-by-step guidance to capture diagnostic-quality images and automated ejection fraction estimation to help inform clinical decisions across cardiac settings.
  • Vscan Air SL with Caption AI is designed to lower the threshold for healthcare professionals to be able to capture cardiac images so that even non-expert ultrasound users can take a quick look at patients’ hearts.
  • "The integration of Caption AI with the Vscan Air SL handheld ultrasound opens an entirely new chapter for cardiac screening.

CVD Equipment Corporation Reports Fourth Quarter and Fiscal Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Batteries, Machinery, Engineering, Chemicals, Plastics, Technology, Aerospace, Semiconductor, Manufacturing, CVV, Silicon carbide, Growth, CVD, Employment, Electronics, Research, Overalls, Wind, OEM, SDC, Investment, PVT, Marketing, Eastern Time Zone, Silicon, Video game

CVD Equipment Corporation (NASDAQ: CVV ), today announced its financial results for the fourth quarter and fiscal year ended December 31, 2023.

Key Points: 
  • CVD Equipment Corporation (NASDAQ: CVV ), today announced its financial results for the fourth quarter and fiscal year ended December 31, 2023.
  • Manny Lakios, President and CEO of CVD Equipment Corporation, commented, “Fourth quarter 2023 revenue was $4.1 million, down significantly versus the prior year period, as our business continues to experience fluctuations in revenue given the nature of the emerging growth end markets we serve.
  • This represents an important milestone for CVD, with potential follow-on production orders should our equipment effectively meet the customers’ needs.
  • Orders for the fourth quarter were $5.8 million driven by continued demand in the aerospace sector and in our SDC segment for gas delivery equipment.