Aortic stenosis

JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet

Retrieved on: 
Thursday, March 28, 2024
Hemodynamics, Disease, TCT, Bernard Marcus, Aortic stenosis, Aortic regurgitation, Patient, Mortality, IDE, Columbia University, Manuscript, MPH, Safety, TAVR, Trial of the century, Trilogy, THV, FDA, Food, Pharmaceutical industry

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .

Key Points: 
  • IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .
  • As presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, the ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.
  • The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients.” Said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).

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

Retrieved on: 
Sunday, April 7, 2024
Health, Sports, Football, Other Health, Other Science, Research, Science, Blood pressure, TTE, FACC, African Americans, Prevalence, Aortic stenosis, National Football League, Patient, Education, Ageing, Journal, History, MD, City, Male, American College, TAVR, EKG, AFL, Interventional cardiology, Alumni association, NFL, National Football League Alumni, Hypertension, Pharmaceutical industry

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.

New survey uncovers lack of awareness around heart valve disease and risk factors among women

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, Health, Cardiovascular disease, Ventricular septal defect, Organization, Prevalence, Coronary artery disease, Disease, Health equity, Risk, Patient, Ageing, Knowledge, Aortic stenosis, Research, Female, Medtronic, MD, Male, American College, TAVR, Fatigue, Dietary supplement

DUBLIN, April 7, 2024 /PRNewswire/ -- Medtronic plc, a global leader in healthcare technology, today unveiled topline findings of its comprehensive survey on women's perceptions and knowledge of risk factors, treatment patterns, and preventive care practices related to heart valve disease. The survey is endorsed by Women as One and was conducted by Wakefield Research sampling 1,000 women in the United States (U.S.) aged 50 and older.

Key Points: 
  • "Heart valve disease awareness deserves broader attention in the U.S., especially considering many women aged 50 and older are at an increased risk of developing the disease.
  • This survey shines a light on the need for increased awareness, early detection, and access to appropriate care for women."
  • Findings from the survey highlight:
    There is a lack of awareness among women about the risks of aortic stenosis (AS) and cardiovascular disease.
  • Despite the prevalence of cardiovascular disease amongst women, awareness is low, with 26% of women not having heard of any of the most common heart-related conditions such as coronary artery disease, congenital heart disease, heart valve disease, or AS, and only 30% of women aged 50 and older having heard of AS.

JenaValve’s Trilogy THV System Highlighted at CRT 2024

Retrieved on: 
Tuesday, March 19, 2024
Observational study, CRT, Conference, Herpetology, Disease, Aortic regurgitation, Patient, Aortic stenosis, Treatment, TAVR, Trilogy, THV, Aorta

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024.

Key Points: 
  • IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024.
  • JenaValve’s Trilogy THV system, a TAVR system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR), and symptomatic, severe aortic stenosis (ssAS), was featured in multiple scientific sessions highlighting the significant unmet need for devices to treat ssAR.
  • This session reviewed an observational study examining outcomes of patients with ssAR treated with off-label THV’s versus a device designed to treat ssAR.
  • Results showed significantly better technical and device success in the Trilogy arm, with significantly less valve embolization, need for a second valve, and post-procedural aortic regurgitation.

egnite, Inc. and JenaValve Announce Novel Research on Outcomes with Untreated Aortic Regurgitation at the 2024 American College of Cardiology Conference

Retrieved on: 
Saturday, April 6, 2024
Research, Technology, Medical Devices, Health Technology, Cardiology, Software, Health, Data Management, Science, Artificial Intelligence, Aortic stenosis, Aortic regurgitation, Patient, Mortality, MD, American College, TAVR, Multimedia, Teaching

egnite, Inc. , a leading digital health company for cardiovascular care, and JenaValve Technology, Inc. , a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, unveil a novel study presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24).

Key Points: 
  • egnite, Inc. , a leading digital health company for cardiovascular care, and JenaValve Technology, Inc. , a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, unveil a novel study presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24).
  • This press release features multimedia.
  • “This research underscores the poor outcomes for patients with moderate AR who exhibit cardiac damage, stressing the need to monitor distinct characteristics in this population.
  • Recent conservative estimates suggest that over 500,000 patients in the United States are diagnosed with moderate or severe AR, indicating a substantial opportunity for novel therapeutic options to treat patients suffering from AR.

Protembis Announces First Patient Enrolled in the PROTEMBO IDE Pivotal Trial

Retrieved on: 
Tuesday, April 2, 2024
General Health, Professional Services, Venture Capital, Medical Devices, Hospitals, Small Business, Clinical Trials, Surgery, Cardiology, Biotechnology, Finance, Health, Brain, Boston Scientific, Aortic stenosis, Cerebral arteries, NewYork-Presbyterian Hospital, Patient, Pivotal trial, IDE, Trial of the century, Hospital, DW, TAVR, Study, CEP, Medical imaging

Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).

Key Points: 
  • Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).
  • The trial will enroll between 250-500 randomized patients undergoing transcatheter aortic valve replacement (TAVR) in the USA and Europe with the ProtEmbo® System, an innovative next generation cerebral embolic protection device (CEP) providing complete 3-vessel coverage of the cerebral arteries.
  • The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-days.
  • This significant progress reflects the close collaboration between our study executive committee, our clinical research organization, and core lab partners in planning this complex trial,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

Retrieved on: 
Tuesday, March 26, 2024
General Health, Professional Services, Venture Capital, Medical Devices, Hospitals, Small Business, Clinical Trials, Cardiology, Biotechnology, Finance, FDA, Health, Brain, Boston Scientific, Growth, Aortic stenosis, Trust, Risk, Patient, Pivotal trial, Research, IDE, Doctor of Philosophy, Stanford University, CMO

Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).

Key Points: 
  • Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).
  • The funding round was structured in two separate capital increases which have both been completed.
  • It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund.
  • Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

Large, Real-world Studies Demonstrate Continued Excellent Outcomes for Patients Receiving Edwards SAPIEN TAVR

Retrieved on: 
Monday, March 11, 2024
Health, Medical Devices, Surgery, Clinical Trials, Research, Science, Cardiology, Registry, CRT, Aortic stenosis, TVT, Patient, Journal, Stroke, Mortality, Ultra, Oakland University, MD, Cardiovascular disease, American College, TAVR, Arrest, JACC, PVL, Medical imaging

Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform.
  • In a second study presented during the late-breaking clinical trials session, small Edwards SAPIEN TAVR valves demonstrated equally excellent outcomes at 3 years as compared to larger SAPIEN TAVR valve sizes.
  • The study found that all Edwards TAVR platforms demonstrated excellent PVL results.
  • An analysis of 8,100 propensity matched patients across more than 800 sites in the United States found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at 3-years, equivalent to those receiving 23, 26 and 29mm SAPIEN valve sizes.

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.