Aortic stenosis

OrbusNeich's Joint Venture Kicks Off TricValve Clinical Trial in Mainland China

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Mercoledì, Aprile 24, 2024
Tricuspid valve, FDA, TMVR, Hope, Hospital, Percutaneous coronary intervention, NMPA, Safety, Valvular heart disease, OrbusNeich, PCI, TAVR, Patient, PTA, Zhongshan Hospital, Fudan University, Cardiology, Aortic stenosis, Clinical trial, Quality of life, Medical device

The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.

Key Points: 
  • The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.
  • It has effectively treated a 56-year-old patient with severe tricuspid regurgitation, marking the commencement of the clinical trial across Mainland China.
  • Led by principal investigator Prof. Ge Junbo, Academician Zhongshan Hospital, Fudan University, and his team, the clinical trial aims to assess the safety and efficacy of TricValve.
  • Mr. Peter Peh, General Manager of OrbusNeich P&F, said, "We are pleased to see TricValve moving into clinical trial, marking the first successful implantation of a percutaneous transcatheter bicaval device in a patient by cardiologists in Mainland China, to address severe tricuspid valve regurgitation.

Verve Therapeutics Announces Pipeline Progress and Reports First Quarter 2024 Financial Results

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Mercoledì, Maggio 8, 2024
LDLR, Verve, Safety, Pharmacokinetics, ASCVD, LNP, Eli Lilly, Moyamoya disease, N-Acetylgalactosamine, RNA, Aortic stenosis, Stroke, Cell, Conference, Research, Webcast, PCSK9, IND, Administration, Potential, Research and development, Patient, Liver, Gene, CAD, Society, Medicine, ANGPTL3, Lilly, Cardiovascular disease, CTAS, Therapy, Asialoglycoprotein receptor, G&A, LPA, Pharmaceutical industry

BOSTON, May 08, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported pipeline updates and financial results for the quarter ended March 31, 2024.

Key Points: 
  • Cash Position: Verve ended the first quarter of 2024 with $606.4 million in cash, cash equivalents, and marketable securities.
  • Collaboration Revenue: Collaboration revenue was $5.7 million for the first quarter of 2024, compared to $1.4 million for the first quarter of 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $14.2 million for the first quarter of 2024, compared to $12.6 million for the first quarter of 2023.
  • Stock-based compensation expense included in G&A expenses was $4.7 million and $3.5 million for the first quarter of 2024 and 2023, respectively.

The Economic Value of Better Heart Health

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Lunedì, Maggio 6, 2024
Mortality, Economy, Health, HVD, The Conference Board, Aortic stenosis, Conference, Research, Conference Board of Canada, Patient, Life expectancy, Diagnosis, Ageing, Quality of life, Growth, Cardiovascular disease, Medical device

“Both the monetary and non-monetary contributions of seniors are vital for supporting our communities,” said Tony Bonen, Director of Economic Research at The Conference Board of Canada.

Key Points: 
  • “Both the monetary and non-monetary contributions of seniors are vital for supporting our communities,” said Tony Bonen, Director of Economic Research at The Conference Board of Canada.
  • “However, most analyses of senior health predominantly focus on minimizing their cost to society, while overlooking the broader economic and social value that healthy seniors provide.”
    With life expectancy on the rise, the senior population is experiencing significant growth.
  • Concurrently, the number of seniors over 65 years old with HVD, a treatable condition prevalent in older adults, is increasing.
  • The collective incremental economic contributions from healthier, longer-living seniors, that might otherwise be limited by HVD, are significant.

Edwards Lifesciences Reports First Quarter Results

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Giovedì, Aprile 25, 2024
Managed Care, Biotechnology, Health, Cardiology, Acumen, Mortality, FDA, Critical care, Investment, Pulmonary artery catheter, Research, Trial of the century, Aortic stenosis, Growth, Ultra, U.S. FDA, ICU, TAVR, Patient, PROGRESS, EPS, Hospital, PASCAL, Quality of life, M3, Heart failure, Pharmaceutical industry

Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended March 31, 2024.
  • Surgical Structural Heart sales for the quarter were $266 million, which grew 7%, or 8% on a constant currency basis.
  • For the quarter, the adjusted gross profit margin was 76.0%, compared to 77.5% in the same period last year.
  • For the second quarter of 2024, the company projects total sales to be between $1.62 and $1.70 billion, and adjusted EPS of $0.67 to $0.71.

Heart-Valve-Surgery.Com and Medtronic Launch Novel "Aortic Stenosis Patient Activation Platform" to Empower Patients

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Giovedì, Aprile 25, 2024
Education, Patient, Stenosis, Social media, Dizziness, Aortic stenosis, Artificial intelligence, Cardiology, MetroHealth, SAVR, Senior, TAVR, Fatigue, Physician, Surgery, Aortic valve, Chest pain, Cardiovascular disease, Heart, Medical device

LOS ANGELES, April 25, 2024 /PRNewswire/ -- Heart-Valve-Surgery.com , a leading patient advocacy group for heart valve disease, with support from Medtronic , a global leader in healthcare technology, today launched the "Aortic Stenosis Patient Activation Platform", an end-to-end digital platform for patient awareness, patient education, and patient activation specific to aortic valve stenosis.

Key Points: 
  • LOS ANGELES, April 25, 2024 /PRNewswire/ -- Heart-Valve-Surgery.com , a leading patient advocacy group for heart valve disease, with support from Medtronic , a global leader in healthcare technology, today launched the "Aortic Stenosis Patient Activation Platform", an end-to-end digital platform for patient awareness, patient education, and patient activation specific to aortic valve stenosis.
  • Aortic stenosis is a narrowing of the aortic valve which prevents the aortic leaflets from opening and closing properly.
  • Patients with aortic stenosis often have heart murmurs and experience debilitating symptoms including chest pain, dizziness, fatigue, shortness of breath and an irregular heartbeat.
  • Because treatment continues to increase and evolve, the "Aortic Stenosis Patient Activation Platform", developed by Heart-Valve-Surgery.com with support from Medtronic and a world-renowned team of physicians, will increase awareness and education for aortic stenosis patients.

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

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Giovedì, Marzo 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

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Domenica, Aprile 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

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Domenica, Aprile 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

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Martedì, Marzo 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: 
Sabato, Aprile 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.