FACC

Milestone® Pharmaceuticals Announces Etripamil Data Demonstrating Patients’ Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting

Retrieved on: 
Lundi, avril 8, 2024

“The promising results of this real-world design study demonstrated patients’ ability to self-manage multiple episodes of PSVT with etripamil,” said David Bharucha, MD, PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals.

Key Points: 
  • “The promising results of this real-world design study demonstrated patients’ ability to self-manage multiple episodes of PSVT with etripamil,” said David Bharucha, MD, PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals.
  • CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, if approved, will be the first rapid, reliable, and at-the-ready option in the acute treatment of PSVT.
  • NODE-303 (ClinicalTrials.gov ID NCT04072835 ) evaluated self-administered etripamil (70 mg, nasal spray) in an outpatient setting for up to multiple episodes of PSVT, without prior test dosing.
  • Both the presentation and publication will be available on the Milestone Pharmaceuticals corporate website at the conclusion of the ACC presentation.

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: 
Dimanche, avril 7, 2024

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.

Milestone® Pharmaceuticals to Present Data on Etripamil at the American College of Cardiology and European Heart Rhythm Association Annual Conferences

Retrieved on: 
Lundi, avril 1, 2024

MONTREAL and CHARLOTTE, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present data on etripamil at two upcoming cardiology conferences this month.

Key Points: 
  • MONTREAL and CHARLOTTE, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present data on etripamil at two upcoming cardiology conferences this month.
  • The company will deliver oral and poster presentations at the American College of Cardiology annual meeting (ACC24) , to be held April 6-8th in Atlanta, Georgia, and a poster presentation at the annual meeting of the European Heart Rhythm Association (EHRA) , to be held April 7-9th in Berlin, Germany.
  • The presentations will be available following the embargo at https://MilestonePharma.com .
  • Multi-Center, Open-Label Study of the Efficacy and Safety of Etripamil Nasal Spray Self-Administered For Multiple Episodes of Symptomatic Supraventricular Tachycardia Without Supervision (Phase 3, NODE-303)
    James Ip, M.D., Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital
    Symptom-prompted, Self-administered Intranasal Etripamil for Termination of Paroxysmal Supraventricular Tachycardia in the RAPID Study: Relationship Among Etripamil-Induced Reduction in Tachycardia Rates, Conversion to Sinus Rhythm, and Improvement in Patient Symptoms
    James Ip, M.D., Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital
    Characterising paroxysmal supraventricular tachycardia episodes by patient-perceived episode duration, symptoms, and severity: longitudinal patient-reported outcomes
    David Bharucha, M.D., Ph.D., FACC, Chief Medical Officer of Milestone Pharmaceuticals, Inc.

Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States

Retrieved on: 
Mercredi, mars 27, 2024

Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.

Key Points: 
  • Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.
  • Renexxion and Dr. Falk Pharma will now expand patient enrollment for the ongoing global multi-center 320 patient placebo-controlled Phase 2b MOVE-IT study in gastroparesis to clinical sites in the United States (ClinicalTrials.gov ID: NCT05621811).
  • Furthermore, naronapride has already demonstrated dose-dependent accelerated gastric emptying in a GI transit study of healthy human volunteers.
  • We are aligned in our belief in the transformative power of naronapride to revolutionize treatment for gastroparesis patients and its ability to reshape the gastroparesis treatment landscape.”

Study of NFL Alumni Cohort Finds Majority Suffer From Heart Disease Without Knowing It

Retrieved on: 
Dimanche, avril 7, 2024

Edwards Lifesciences (NYSE: EW) announced the release of data from the HUDDLE study that examined the prevalence of heart disease and associated risk factors among members of the National Football League (NFL) Alumni Association and their families.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) announced the release of data from the HUDDLE study that examined the prevalence of heart disease and associated risk factors among members of the National Football League (NFL) Alumni Association and their families.
  • Results of the HUDDLE study indicated that the prevalence of hypertension in the 498 screened participants was 83.8%, though only about half (46.5%) self-reported a history of hypertension.
  • Conducted across eight U.S. cities in cooperation with NFL Alumni Health, a subsidiary of the NFL Alumni Association, HUDDLE was a cross sectional study of NFL alumni and their family members aged 50 years and above.
  • Study participants self-reported their medical histories and participated in heart health education and screenings that included blood pressure, electrocardiogram (EKG) and echocardiogram.

Cathie Biga is New American College of Cardiology President

Retrieved on: 
Lundi, avril 8, 2024

ATLANTA, April 8, 2024 /PRNewswire/ -- Cathie Biga, MSN, FACC, today became president of the American College of Cardiology and made history as the organization's first non-physician president. She will serve a one-year term representing over 56,000 cardiovascular care team members around the world and leading the cardiovascular organization in its mission to transform cardiovascular care and improve heart health for all.

Key Points: 
  • ATLANTA, April 8, 2024 /PRNewswire/ -- Cathie Biga, MSN, FACC, today became president of the American College of Cardiology and made history as the organization's first non-physician president.
  • "The concept of 'standing on the shoulders of giants' is often referenced when talking about leadership changes and transformation over time.
  • She's been a member of the ACC Board of Trustees for six years, most recently serving as vice president.
  • The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all.

HeartFlow Announces Publication of 10-year Follow-Up Data from the DISCOVER-FLOW Study in the Journal of Cardiovascular Computed Tomography

Retrieved on: 
Mardi, mars 12, 2024

MOUNTAIN VIEW, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that 10-year follow-up data from its DISCOVER-FLOW study were published in the Journal of Cardiovascular Computed Tomography.

Key Points: 
  • MOUNTAIN VIEW, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that 10-year follow-up data from its DISCOVER-FLOW study were published in the Journal of Cardiovascular Computed Tomography .
  • The company has spent the last decade working with clinicians to improve CAD diagnosis, making significant progress validated by high quality clinical evidence.
  • HeartFlow’s approach is centered around scientific rigor with peer-reviewed publications to provide confidence and certainty to clinicians and the patients they serve.
  • Together, this comprehensive solution offers valuable data not currently available with other non-invasive diagnostic tools or CTA-based AI analyses.

Viz.ai® Announces Three New Studies Supporting Viz HCM™ Module for the Detection and Management of Suspected Hypertrophic Cardiomyopathy

Retrieved on: 
Mercredi, avril 3, 2024

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in cardiology care.

Key Points: 
  • Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in cardiology care.
  • The Viz HCM module is the first and only AI algorithm cleared by the FDA for HCM.
  • The study found that Viz HCM performance in suspected HCM detection was consistent across various racial backgrounds with a sensitivity of 68.4% and specificity of 99.1%.
  • This validates the effectiveness of relevance score sorting for prioritizing higher probability HCM-positive patients identified by deep-learning algorithms analyzing ECG data.

PaceMate Hits 100,000th Patient Transmission Milestone with Cutting-Edge Ambulatory Remote Monitoring Platform

Retrieved on: 
Mardi, avril 2, 2024

PaceMate®, a market-leading cardiac remote monitoring and cardiac data management platform , announced today the completion of its 100,000th ambulatory patient transmission managed through PaceMateLIVE™.

Key Points: 
  • PaceMate®, a market-leading cardiac remote monitoring and cardiac data management platform , announced today the completion of its 100,000th ambulatory patient transmission managed through PaceMateLIVE™.
  • PaceMate leverages advanced algorithms to deliver the only end-to-end solution, merging the entire workflow – from ordering to billing – into a singular, efficient experience.
  • PaceMate is the universal solution for cardiac data management across the disease spectrum," said Tripp Higgins, CEO and Co-Founder of PaceMate.
  • PaceMate provides clinicians the flexibility to choose from the top five ambulatory monitoring manufacturers with one single integration for a tailored healthcare solution.

First Patients Enrolled in Pivotal Study Evaluating HeartBeam’s AIMIGo™ System for Synthesizing a 12-Lead ECG

Retrieved on: 
Jeudi, mars 14, 2024

HeartBeam AIMIGo leverages HeartBeam’s proprietary 3D vectorelectrocardiography (3D VECG) technology to capture signals in three projections (X, Y, Z) and synthesize a 12-lead ECG.

Key Points: 
  • HeartBeam AIMIGo leverages HeartBeam’s proprietary 3D vectorelectrocardiography (3D VECG) technology to capture signals in three projections (X, Y, Z) and synthesize a 12-lead ECG.
  • “We are thrilled to be part of this important study as AIMIGo represents a significant leap in cardiac monitoring technology.
  • All patients enrolled in the study will receive simultaneously recorded ECGs from a standard 12-lead ECG machine and the HeartBeam AIMIGo system.
  • The study will also examine the accuracy of physician diagnosis for various arrhythmias with the AIMIGo synthesized 12-lead ECG, compared to a standard 12-lead ECG.