Aortic stenosis

Saranas Reveals Groundbreaking SAFE-MCS Study Results at CRT 2024

Retrieved on: 
Monday, March 11, 2024
Surgery, Medical Devices, Health, Clinical Trials, Cardiology, CRT, Aortic stenosis, Physician, Risk, Early, Patient, Percutaneous coronary intervention, Henry Ford Health, MCS, PROTECT, Morristown Medical Center, Henry Ford, PCI, Bleeding, EVAR, Safety, Structural heart disease, TAVR, FDA

“This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.

Key Points: 
  • “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.
  • “We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Mike MacKinnon, CEO and President of Saranas.
  • Saranas is dedicated to establishing a new benchmark for bleed detection during and after endovascular procedures, with the goal of improving patient outcomes and decreasing healthcare expenses overall.”

Abbott Receives FDA Approval for TriClip™, First-of-Its-Kind Device to Repair Leaky Tricuspid Heart Valve

Retrieved on: 
Tuesday, April 2, 2024
Disease, Atrial fibrillation, Risk, Anatomy, Patient, Aortic stenosis, Endoclip, Tricuspid regurgitation, Structural heart disease, Death, Tricuspid valve, Abbott Northwestern Hospital, Quality of life, Heart failure, Leg, Heart, MitraClip, Safety, Fatigue, Blood, FDA, Physician, Food, Pharmaceutical industry

The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle.

Key Points: 
  • The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle.
  • TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart.
  • TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath.
  • TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020.

Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis

Retrieved on: 
Wednesday, March 27, 2024
Hemodynamics, Aortic stenosis, Patient, Medtronic, Quality of life, Heart failure, Coronary, TAVR, FX, FDA, Physician

DUBLIN, March 27, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.

Key Points: 
  • DUBLIN, March 27, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.
  • The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.
  • The Evolut FX+ TAVR system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of the Evolut TAVR system.
  • If left untreated, 50% of patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.2
    The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the U.S.

Academy Award® Winner Matthew McConaughey Narrates MacGillivray Freeman's 3D Documentary for IMAX® and Giant Screen Theaters "Superhuman Body: World of Medical Marvels"

Retrieved on: 
Tuesday, March 26, 2024
Citadel, First Citizens BancShares, Health, Personality, Organization, CGI, Edwards Lifesciences, Aortic stenosis, Woman, Philosophy, MIT, Patient, Social media, Dazed and Confused, 3D, Leukemia, Richard King Mellon, Life, Cardiovascular disease, Burroughs Wellcome Fund, IMAX, Dallas Buyers Club, MacGillivray Freeman Films, TAVR, Family, Human, Television, Entertainment

LOS ANGELES, March 26, 2024 /PRNewswire/ -- MacGillivray Freeman Films is pleased to announce that Academy Award®-winning actor Matthew McConaughey will narrate the company's newest 3D giant screen film, Superhuman Body: World of Medical Marvels, for release in select IMAX® and giant screen theatres starting April 12, 2024. 

Key Points: 
  • LOS ANGELES, March 26, 2024 /PRNewswire/ -- MacGillivray Freeman Films is pleased to announce that Academy Award®-winning actor Matthew McConaughey will narrate the company's newest 3D giant screen film, Superhuman Body: World of Medical Marvels, for release in select IMAX® and giant screen theatres starting April 12, 2024.
  • Matthew McConaughey narrates "Superhuman Body: World of Medical Marvels" -- hitting IMAX and giant screens April 12!
  • This film will inspire you, move you, empower you, and you'll be amazed by what your superhuman body can do."
  • "We are delighted to have the talented Matthew McConaughey add his distinctive voice to the project."

RWJBarnabas Health and Rutgers Health to Showcase Breakthrough Cardiology Data at the American College of Cardiology Scientific Session & Expo

Retrieved on: 
Monday, March 25, 2024
CMR, TME, FACC, National Health Interview Survey, Research, Obesity, Hypertension, MRI, Cooperman Barnabas Medical Center, Facial muscles, HIV, Diabetes, Risk, National Health, Patient, Stroke, RWJBarnabas Health, Community Medical Center, Mortality, Aortic stenosis, American College of Cardiology, Telehealth, Faculty, New Jersey Medical School, NHIS, Abstract, American College, Smoking, LVDD, Rutgers University, Division, TAVR, Collection, Jersey City Medical Center, ACC, YPLL, Acute coronary syndrome, Health, Meta-analysis, Dietary supplement

WEST ORANGE, N.J., March 25, 2024 /PRNewswire/ -- Physician-scientists from RWJBarnabas Health and Rutgers Health will present an extensive portfolio of innovative cardiovascular data from their clinical research program at the American College of Cardiology's (ACC) Annual Scientific Session & Expo in Atlanta, Georgia on April 6 to 8, 2024. A total of 59 abstracts have been accepted, composed of data evaluating and educating on risk factors, treatment options and ongoing research advances to improve cardiovascular care and outcomes for patients.

Key Points: 
  • A total of 59 abstracts have been accepted, composed of data evaluating and educating on risk factors, treatment options and ongoing research advances to improve cardiovascular care and outcomes for patients.
  • RWJBarnabas Health cardiac centers of excellence are nationally recognized for patient care and superior outcomes, including being named as one of Becker's top 100 Great Heart Programs in the country and recognized by American College of Cardiology as a Proven Quality Program.
  • Prior studies suggest that distinct patient subgroups with aortic stenosis may experience left ventricular systolic and diastolic dysfunction before the development of severe AS.
  • The study included patients who had received an angiogram done within 14 days of the CMR.

EISENHOWER HEALTH EARNS NATIONAL RECOGNITION WITH HeartCARE CENTER DESIGNATION

Retrieved on: 
Wednesday, February 28, 2024
TAVR, Hospital, BSN, Aortic stenosis, Resuscitation, Registry, RN, Electrophysiology, MBA, Cardiology, Heart failure, NCDR, American College, Patient, MPH, FACC, Disease, Heart, ACC, Coachella Valley, Accreditation, PCI, Nursing

RANCHO MIRAGE, Calif., Feb. 28, 2024 /PRNewswire/ -- The American College of Cardiology has recognized Eisenhower Health for its demonstrated commitment to comprehensive, high-quality culture and cardiovascular care. Eisenhower Health was awarded the HeartCARE Center National Distinction of Excellence based on meeting accreditation criteria, and through their ongoing performance registry reporting.

Key Points: 
  • Eisenhower Health was awarded the HeartCARE Center National Distinction of Excellence based on meeting accreditation criteria, and through their ongoing performance registry reporting.
  • "We are proud to be the Coachella Valley's only heart program to earn the HeartCARE Center distinction.
  • "ACC Accreditation Services is proud to award Eisenhower Health with the HeartCARE Center designation."
  • Eisenhower Health has proven to be a forward-thinking institution with goals to advance the cause of sustainable quality improvement.

Edwards Lifesciences Reports Fourth Quarter Results

Retrieved on: 
Tuesday, February 6, 2024
Health, Medical Devices, Biometrics, Health Technology, General Health, Cardiology, Biotechnology, Acumen, EPS, SMART Recovery, Critical care, Growth, Mortality, PASCAL, Science, Aortic stenosis, PROGRESS, TAVR, Clinical trial, Research, Patient, FDA, Investment, M3, CE marking, Heart failure, Hypotension, Share repurchase, Completeness, U.S. FDA, Pharmaceutical industry

Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended December 31, 2023.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended December 31, 2023.
  • In the fourth quarter, Edwards remained focused on its key value drivers to unlock the significant long-term opportunity for patients: a portfolio of differentiated therapies; positive clinical trial results to support approvals and adoption; and favorable real-world clinical outcomes.
  • Research and development expenses in the fourth quarter grew 16 percent over the prior year to $270 million, or 17.6 percent of sales.
  • During the fourth quarter, the company repurchased $444 million of stock through a combination of a pre-established trading plan and accelerated share repurchase programs.

CardioSignal Raises $10 Million in Series A as the First Technology to Detect Major Heart Diseases without Specialized Medical Hardware

Retrieved on: 
Tuesday, January 23, 2024
Research, Telemedicine, Virtual Medicine, Insurance, Software, Medical Devices, Internet, Hardware, Professional Services, Consumer Electronics, Science, Technology, Mobile, Wireless, Clinical Trials, Cardiology, Health, Apps, Applications, Health Technology, Health Insurance, Atrial fibrillation, Death, Coronary artery disease, Patient, Heart, Aortic stenosis, Aorta, Heart failure, Mayo Clinic, Risk, Xerox, Biomarker, Sandwater, Pulmonary hypertension, Motion, Smartphone, Pharmaceutical industry

The Series A investment will fund additional clinical validation of CardioSignal’s breakthrough technology and the expansion of its commercial efforts.

Key Points: 
  • The Series A investment will fund additional clinical validation of CardioSignal’s breakthrough technology and the expansion of its commercial efforts.
  • CardioSignal develops digital technologies and software-as-medical-devices to provide early detection of heart diseases, and provides the first and only technology to detect several major heart diseases with high accuracy using just one clinical modality without any specialized medical equipment.
  • CardioSignal’s technology harnesses gyroscope and accelerometer motion data from smartphones to measure specific rotational movements of the heart that can be used to accurately detect abnormal heart function.
  • Currently, primary care has very limited tools to detect heart diseases, like heart failure patients who are often already experiencing symptoms.

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™

Retrieved on: 
Monday, January 22, 2024
Health, FDA, Medical Devices, Health Technology, Other Health, Cardiology, Biotechnology, Patient, Hemodynamics, MD, Percutaneous aortic valve replacement, Aortic stenosis, TMVR, Risk, Food, Morristown Medical Center, Heart, TAVR, Diagnosis, Medical device

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.

Key Points: 
  • Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.
  • This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023.
  • “Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut™,” said Philippe Genereux, MD from Morristown Medical Center in New Jersey.
  • “Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut™ to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve.

JenaValve Featured at the PCR London Valves 2023

Retrieved on: 
Wednesday, December 6, 2023
Patient, Mitral regurgitation, Hospital, Aortic stenosis, Prevalence, Aortic regurgitation, Columbia, THV, Aortic valve, Diagnosis, TCT, Surgery

IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from PCR London Valves 2023, a leading, annual global valve conference.

Key Points: 
  • IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from PCR London Valves 2023, a leading, annual global valve conference.
  • We have seen cases where the severe MR went away after treating the AR," said Professor Andreas Baumbach, Chair for Device Innovation at Queen Mary University of London.
  • "We are still learning a lot about how to best treat AR, but the possibility of Trilogy as a treatment option is encouraging."
  • The 2023 PCR London Valves Course followed the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting in October, during which JenaValve's pivotal ALIGN-AR study results were presented.