GDMT

CVRx announces availability of additional data supporting long-term benefits of Barostim

Retrieved on: 
Monday, April 15, 2024
Pain, FDA, Patient, CCM, GDMT, Risk, Abstract, Vanderbilt University, Death, THT, Depression, Heart failure, NYHA, Science, European Journal, Fatigue, CRT, Manuscript, Hospital, LVAD, Quality of life, Therapy, HF, Hykes, Pharmaceutical industry

MINNEAPOLIS, Minn., April 15, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.

Key Points: 
  • (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure.
  • These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.
  • CVRx previously announced some of these data as part of expanded labeling granted by FDA on December 23, 2023.
  • We look forward to the generation of additional evidence about Barostim from the BeAT-HF trial, as well as from real-world experience through our REBALANCE post-market registry and investigator-initiated research,” said Hykes.

New Study Published in JACC: Heart Failure Reveals that Despite Significant Efforts to Improve Acute Heart Failure Treatment Over the Past 20 Years, Management Remains Unchanged

Retrieved on: 
Thursday, May 2, 2024
Research, Medical Devices, Hospitals, Clinical Trials, Health Technology, Cardiology, Biotechnology, Managed Care, Health, Science, Stanford University, Mortality, Heart, Fluid, Heart failure, ADHF, American College, Clinical trial, GDMT, AUC, Hospital, Weight loss, Partnership, Area studies, Nursing, Patient, Reprieve, Physician, Acute, Circulatory system, Kaiser Permanente, Hyperkalemia, SDOH, HF, Division, Hypotension, Pharmaceutical industry

Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss are not well described.

Key Points: 
  • Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss are not well described.
  • In the TREAT-AHF study, the distribution of inpatient body weight change was similar to those reported from ADHERE nearly two decades ago.
  • Reprieve is partnering with industry-leading heart failure researchers and Truveta to understand and advance acute heart failure patient outcomes.
  • The clinical evidence from the TREAT-HF study demonstrates that heart failure decongestion management has not substantially changed in 20 years,” said Mark Pacyna, chief executive officer of Reprieve Cardiovascular.

Clinical Data on the Impact of Sotagliflozin on Stroke and Heart Attack Risk Among Four Lexicon-Sponsored Presentations at the American College of Cardiology 73rd Annual Scientific Session & Expo

Retrieved on: 
Monday, March 25, 2024
Shift, Protein kinase B, Cardiology, Stroke, Health, Myocardial infarction, SGLT1, Chronic kidney disease, CKD, Risk, Theatre, Endothelium, Inflammation, Knowledge, SGLT2, Diabetes, HF, University of Colorado, Vessel, University of Michigan, Inhibitor, University, Coagulation, Protein, GDMT, Heart failure, American College, Type 2 diabetes, Vasodilation, Food, Hospital, Pharmaceutical industry

In a post-hoc analysis of data from the 10,584 patients in the SCORED Phase 3 clinical trial, 213 all-cause stroke events occurred, including 29 (13.6%) fatal events.

Key Points: 
  • In a post-hoc analysis of data from the 10,584 patients in the SCORED Phase 3 clinical trial, 213 all-cause stroke events occurred, including 29 (13.6%) fatal events.
  • Sotagliflozin reduced the risk of all-cause stroke by 34%, with 1.2 events per 100 patient-years in the sotagliflozin group and 1.8 events per 100 patient-years in the placebo group.
  • Similarly, sotagliflozin reduced the risk of ischemic stroke by 32%, with 0.8 events per 100 patient-years in the sotagliflozin group and 1.2 events per 100 patient-years in the placebo group.
  • Candidate, University of Michigan, Ann Arbor, Michigan
    Study researchers found that sotagliflozin inhibits platelet activation through simultaneously targeting SGLT1 and SGLT2.

ChristianaCare Improves Care for Black Patients Living with Heart Failure and Hypertension

Retrieved on: 
Thursday, February 22, 2024
Health, Telemedicine, Virtual Medicine, Hospitals, Health Technology, Health Insurance, Managed Care, Cardiology, Blood pressure, Hospital, ChristianaCare, GDMT, Healthgrades, Risk, Heart failure, Hypertension, Death, American College, Patient, SGLT2, Health equity, Medicine, Pharmaceutical industry

Through this innovative approach, ChristianaCare achieved a significant improvement in the number of Black patients adhering to prescribed doses of guideline-directed medical therapy (GDMT) for heart failure.

Key Points: 
  • Through this innovative approach, ChristianaCare achieved a significant improvement in the number of Black patients adhering to prescribed doses of guideline-directed medical therapy (GDMT) for heart failure.
  • "As we celebrate heart month this February, we are proud that we have been able to significantly improve the health outcomes of our patients, especially addressing health disparities in the Black population for patients with heart failure and hypertension."
  • Approximately 32% of ChristianaCare’s heart failure patient population identify as Black, which is a higher percentage compared to the Black population nationally (12.4%).
  • In addition to heart failure patients, ChristianaCare’s collaboration with Story Health supported patients with hypertension, delivering significant reductions in blood pressure for those enrolled regardless of race.

Aidoc and American College of Cardiology Collaborate to Revolutionize Cardiovascular Care with Best-in-Class AI

Retrieved on: 
Thursday, February 29, 2024
Stroke, Algorithm, Radiology, AI, Health equity, MD, Physician, FDA, American College of Cardiology, Cardiovascular disease, Injury, GDMT, Calcium, Coronary artery disease, Splenic infarction, Risk, CAC, Documentation, Emergency department, American College, Organization, Patient, Anatomy, ACC

NEW YORK, Feb. 29, 2024 /PRNewswire/ -- AI pioneer Aidoc and the American College of Cardiology (ACC) are collaborating to revolutionize cardiovascular care through industry-leading artificial intelligence (AI) technology. This collaboration will drive enhanced outcomes for patients with incidentally identified coronary artery calcification (CAC) by ensuring that all patients receive the most effective follow-up and ACC guideline-concordant treatment.

Key Points: 
  • NEW YORK, Feb. 29, 2024 /PRNewswire/ -- AI pioneer Aidoc and the American College of Cardiology (ACC) are collaborating to revolutionize cardiovascular care through industry-leading artificial intelligence (AI) technology.
  • Aidoc's FDA-cleared proprietary technology communicates findings to radiologists and enables coordinated, automatic patient follow-up care.
  • "Our collaboration with Aidoc is aligned with the ACC's mission to transform cardiovascular care and improve heart health for all," stated Ami Bhatt, MD, Chief Innovation Officer, American College of Cardiology.
  • "Collaborating with the American College of Cardiology represents a landmark moment in our mission to harness AI's potential in healthcare.

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Retrieved on: 
Friday, January 5, 2024
Cordella, Food, FDA, NYHA, News, IDE, GDMT, Congestion, Patient, HF, Heart failure, PMA, Vital signs, Pharmaceutical industry

NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).
  • Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home.
  • "Submitting this PMA application is a significant regulatory milestone and brings us one step closer to the expected commercial launch of the Cordella Sensor in the second half of this year."
  • This news follows the company's prior announcement that PROACTIVE-HF, the company's 450-patient investigational device exemption (IDE) trial, completed enrollment .

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Retrieved on: 
Friday, January 5, 2024
Cordella, Food, FDA, NYHA, News, IDE, GDMT, Congestion, Patient, HF, Heart failure, PMA, Vital signs, Pharmaceutical industry

NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).
  • Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home.
  • "Submitting this PMA application is a significant regulatory milestone and brings us one step closer to the expected commercial launch of the Cordella Sensor in the second half of this year."
  • This news follows the company's prior announcement that PROACTIVE-HF, the company's 450-patient investigational device exemption (IDE) trial, completed enrollment .

Cadence Releases First Outcomes Report: Remote Patient Monitoring-Powered Chronic Disease Care Offers the Path Forward

Retrieved on: 
Thursday, December 14, 2023
Nursing, Health, Telemedicine, Virtual Medicine, Hospitals, Practice Management, Health Technology, Managed Care, Hypertension, Protocol, Conditional sentence, Federal Medical Centres, Practitioner, Community Health Systems, RPM, EMR, Patient, GDMT, LifePoint Health, Heart failure, Partnership, Growth, Physician, Quality of life, Education, Pharmaceutical industry, Medical device, Cadence

The report finds that an advanced practice provider-led remote patient monitoring (RPM) program with proven treatment protocols provides a scalable solution for chronic care management nationwide.

Key Points: 
  • The report finds that an advanced practice provider-led remote patient monitoring (RPM) program with proven treatment protocols provides a scalable solution for chronic care management nationwide.
  • Improved adherence to all four pillars of GDMT significantly improves clinical outcomes and quality of life for heart failure patients.
  • Across various analyses, Cadence patients also experienced a significant decrease in their total cost of care after enrollment.
  • Taken together, these results underscore the potential for broad-scale change by using RPM-powered virtual care to improve preventative care for patients with chronic disease.

Ventricle Health secures $8M in seed financing led by RA Capital Management, along with Waterline Ventures and others to accelerate national delivery of its value-based home care model for heart failure patients

Retrieved on: 
Tuesday, October 17, 2023
RA, Waterline, Cardiology, Heart failure, Kidney, Ageing, Acos, Accountable care organization, GDMT, Kidney disease, Patient, Quality of life, Pharmaceutical industry, Medical device

This investment round will finance the expansion of Ventricle Health’s heart failure management therapeutic model in collaboration with value-based care provider groups and payers.

Key Points: 
  • This investment round will finance the expansion of Ventricle Health’s heart failure management therapeutic model in collaboration with value-based care provider groups and payers.
  • They provide patients access to cardiology care appointments from their home in as little as three days.
  • Ventricle Health’s home-based and virtually enabled care model can reduce the overall average annual cost of heart failure care by at least 30-50%.
  • Employer health costs are similarly rising related to increasing heart failure diagnoses in their aging employee populations.

Clint and ACC Collaborate on Innovations to Advance Precision Health and Expand Access to Clinical Trials

Retrieved on: 
Thursday, September 28, 2023
ACC, American College of Cardiology, Public, FACC, Stanford University, Research, GDMT, Clint, Patient, Machine learning, American College, Health, Epidemiology, Data science, Pharmaceutical industry, Nursing, MD

Redwood City, California, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Clint, the clinical intelligence platform , is collaborating with the American College of Cardiology to advance precision health and expand access to clinical trials.

Key Points: 
  • Redwood City, California, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Clint, the clinical intelligence platform , is collaborating with the American College of Cardiology to advance precision health and expand access to clinical trials.
  • Leveraging advanced data science methodologies, Clint automates patient chart assessment, identifying opportunities for improved patient management and also assessing patient eligibility for clinical trials.
  • “ACC is mission driven to transform cardiovascular care and improve heart health for all,” said Ami Bhatt, MD, FACC, ACC Chief Innovation Officer.
  • Innovating by using computational science to power diverse clinical trials can increase the relevance of clinical trials for all individuals and lead to more precise treatment methods for all populations.”