KCCQ

Edwards’ EVOQUE Valve Replacement System First Transcatheter Therapy to Earn FDA Approval for Tricuspid Valve

Retrieved on: 
Friday, February 2, 2024
Science, Cardiology, Research, Surgery, Health, FDA, Medical Devices, Clinical Trials, Multimedia, NYHA, Mortality, Tricuspid regurgitation, Hospital, MD, TCT, Food and Drug Administration, Edwards Lifesciences, Patient, Columbia University, Food, CE marking, Quality of life, Risk, Tricuspid valve, KCCQ, OMT

Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).

Key Points: 
  • Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).
  • The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
  • “The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients.
  • The EVOQUE system received CE Mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to receive regulatory approval to treat TR.

BridgeBio Pharma Announces Publication of Positive Results from Phase 3 ATTRibute-CM Study of Acoramidis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in the New England Journal of Medicine

Retrieved on: 
Wednesday, January 10, 2024
ACT, Mortality, Social Security, Serum, American Heart Association, Patient, ACM, Research, Hospital, PALO, TTR, Cancer, Survival rate, Food, NDA, Safety, ATTR, FDA, Cardiology, NEJM, Marketing, New Drug Application, CVH, KCCQ, Amyloidosis, University college, Dietary supplement

ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, small molecule stabilizer of transthyretin (TTR).

Key Points: 
  • ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, small molecule stabilizer of transthyretin (TTR).
  • Findings presented in the NEJM support acoramidis as an effective and safe treatment option for patients with ATTR-CM and reinforce the hypothesis that greater stabilization of TTR may be associated with improved clinical outcomes.
  • BridgeBio has also presented additional detailed results from ATTRibute-CM at the European Society of Cardiology Congress 2023 in August and at the American Heart Association Scientific Sessions 2023 in November .
  • The Company submitted a New Drug Application to the U.S. FDA in 2023 and intends to submit additional marketing authorization applications to regulatory bodies in 2024.

Thubrikar Aortic Valve Announces Authorization to Expand the TAVI-1 CE Mark Trial with the Precision 2™ Delivery Catheter

Retrieved on: 
Friday, December 15, 2023
Other Health, Other Philanthropy, Other Science, Pharmaceutical, Research, Venture Capital, Medical Devices, Fund Raising, Hospitals, Professional Services, Foundation, Philanthropy, Science, Clinical Trials, Cardiology, General Health, Biotechnology, Surgery, Health, NYU Langone Health, DRS, Pressure, Structural heart disease, Mortality, TAV, Patient, University Medical Center, Aortic valve, KCCQ, Stroke, TAVI, Competence, Freedom, Hospital, Mathematical optimization, Medical device, Bara Kodali

Thubrikar Aortic Valve, Inc. today announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™).

Key Points: 
  • Thubrikar Aortic Valve, Inc. today announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™).
  • The authorization allows for an additional 15 patients to be treated with the Optimum TAV™ using the Company’s 2nd-generation delivery catheter, the Precision 2™ Catheter.
  • It allows the Optimum TAV to be repositioned and recaptured for retrieval, if necessary, during the TAVI procedure.
  • Due to the innovative catheter design, the Optimum TAV’s short frame reorients as it is deployed in the diseased valve which results in automatic axial alignment of the valve.

Imbria Reports Positive Topline Results for Investigational New Drug Ninerafaxstat in Patients with Non-obstructive Hypertrophic Cardiomyopathy

Retrieved on: 
Tuesday, November 7, 2023
CPET, Lahey Hospital & Medical Center, KCCQ, Medical Center, Disease, Clinical trial, Heart failure with preserved ejection fraction, Safety, Patient, Heart failure, Ex-gay movement, Medical imaging, Pharmaceutical industry

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to improve patient symptoms and function by enhancing cellular energetics, today announced positive topline results from the Phase 2 IMPROVE-HCM clinical trial, evaluating ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation (pFOX) inhibitor, in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), a large orphan disease with no approved therapies.

Key Points: 
  • Treatment with ninerafaxstat was well tolerated and no safety signals were observed.
  • At 12-weeks, treatment with ninerafaxstat showed a statistically significant improvement in a robust functional cardiopulmonary exercise test (CPET) measure of established prognostic significance in patients with nHCM and heart failure with preserved ejection fraction (HFpEF).
  • “Based on the topline results from IMPROVE-HCM, we are focused on advancing ninerafaxstat into a Phase 3 clinical trial of patients with nHCM and plan to meet with regulatory agencies within the coming months to confirm trial design.
  • Imbria anticipates sharing full data from the IMPROVE-HCM Phase 2 clinical trial at an upcoming medical conference.

Bristol Myers Squibb to Present Data from Innovative Cardiovascular Portfolio at the American Heart Association Scientific Sessions 2023

Retrieved on: 
Monday, November 6, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, NYHA, BMY, Bristol Myers Squibb, Stroke, Ventricular fibrillation, NYSE, NVAF, Medicare, Clinical trial, Physician, KCCQ, Senior, American Heart, Risk, Pharmacy, HCM, AHA, Patient, Cardiovascular disease, New York Heart Association Functional Classification, Pharmaceutical industry, Medical device, Development

Bristol Myers Squibb (NYSE: BMY) today announced that research across the company’s cardiovascular franchise will be presented at the American Heart Association’s (AHA) annual Scientific Sessions, taking place November 11-13, 2023 in Philadelphia, Pennsylvania.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that research across the company’s cardiovascular franchise will be presented at the American Heart Association’s (AHA) annual Scientific Sessions, taking place November 11-13, 2023 in Philadelphia, Pennsylvania.
  • A retrospective cohort study of claims data from commercial specialty pharmacies demonstrating high real-world adherence to CAMZYOS in >600 patients with symptomatic obstructive HCM in the United States.
  • An analysis of Medicare claims data from 2016 to 2020 investigating evidence of diagnosis-related disparities in patients over 65 with HCM specifically relating to race/ethnicity and county-level disparities.
  • Select Bristol Myers Squibb and Bristol Myers Squibb-Pfizer Alliance studies at AHA Congress 2023 include:

Late-Breaking Data Showcase the Benefits of Abbott's Minimally Invasive Devices for People With Leaky Heart Valves

Retrieved on: 
Tuesday, October 24, 2023
NYHA, MitraClip, Tricuspid regurgitation, NYSE, Health, MR, TR, Self-assessment, Mortality, Icahn School of Medicine at Mount Sinai, Functional, Mount Sinai Health System, G4, Quality of life, Endoclip, Risk, Mount Sinai, Blood, Safety, TCT, Hospital, Patient, Mitral regurgitation, Heart failure, ACC, New York Heart Association Functional Classification, Dietary supplement, Medical imaging, Pharmaceutical industry, Nursing, Medical device, KCCQ

Leaky valves in people with MR and TR can reduce the amount of blood being pumped through the body and make the heart work harder than it should.

Key Points: 
  • Leaky valves in people with MR and TR can reduce the amount of blood being pumped through the body and make the heart work harder than it should.
  • As a result, MR and TR can lead to other cardiovascular issues as well as severely limit a person's quality of life.
  • "For more than two decades, Abbott has continued to evolve and expand its minimally invasive treatment options for mitral and tricuspid regurgitation.
  • TriClip is approved for use in more than 50 countries, including in Europe and Canada, and is an investigational device in the U.S.

Late-Breaking Data Confirms Safety of Axon Therapies' Innovative Heart Failure Procedure and Identifies Patients Most Likely to Benefit from SAVM Therapy

Retrieved on: 
Sunday, October 8, 2023
Heart Failure Society of America, Hemodynamics, Mercury (element), Late, Structural heart disease, MD, KCCQ, Heart, Safety, Congestion, Sympathetic nervous system, OH, Duke University Hospital, Parallel Walk Test, Patient, Blood volume, GSN, Heart failure, Heart failure with preserved ejection fraction, PCWP, Cardiac output, Feinberg School of Medicine, Exertion, Exercise, MHS, Medical imaging, Pharmaceutical industry, Research, Medicine

"SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients.

Key Points: 
  • "SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients.
  • The full treatment arm results confirmed the SAVM procedure was safe with no difference in procedure-related adverse events compared to the sham arm.
  • The improvements SAVM demonstrated in the responder group at 6 months were sustained in patients who have available 12-month data.
  • These data will be foundational to our efforts to bring this therapy to the patients who need it most."

Rocket Pharmaceuticals Reaches FDA Alignment on Pivotal Phase 2 Trial Design for RP-A501 in Danon Disease

Retrieved on: 
Tuesday, September 12, 2023
Research, FDA, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Science, NYHA, Male, CMS, LV, Troponin, IMPD, CMC, Center for Biologics Evaluation and Research, CTA, KCCQ, Disorder, Natriuresis, Medication, New York Heart Association Functional Classification, Food and Drug Administration Amendments Act of 2007, Clinical trial, CGMP, Patient, Heart transplantation, Immunohistochemistry, Mortality, Danon disease, Death, Food, Safety, Disease, Pharmaceutical industry, Medical device, EU, LAMP2

The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.

Key Points: 
  • The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe.
  • A global natural history study will serve as an external comparator and run concurrently to the Phase 2 pivotal trial.
  • In-house manufacturing has been completed with sufficient high-quality drug product produced to fully supply the Phase 2 pivotal study.
  • Additionally, Rocket has secured an ICD-10 code from CMS for LAMP2 deficiency in Danon Disease

Cytokinetics Announces Start of ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Retrieved on: 
Wednesday, September 6, 2023
Atrial flutter, RER, NYHA, Research and development, Heart failure, Cohort, Atrial fibrillation, LVEF, Quality of life, Part, KCCQ, New York Heart Association Functional Classification, Cytokinetics, Patient, N-terminal prohormone of brain natriuretic peptide, SAN, Mercury (element), VO2, Assessment, III, HCM, Pharmaceutical industry, Medical imaging

“As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.

Key Points: 
  • “As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.
  • The primary endpoint is the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score from baseline to Week 36.
  • ACACIA-HCM is expected to enroll 420 patients, randomized on a 1:1 basis to receive aficamten or placebo.
  • Patients who complete ACACIA-HCM will be eligible to participate in an open-label extension clinical trial.

Cytokinetics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
CSS, NYHA, Heart failure, Clinical study design, Symantec Endpoint Protection, Cohort, Safety, Food, Library classification, Completeness, Metoprolol, Journal of Cardiac Failure, KCCQ, New York Heart Association Functional Classification, Journal, Cytokinetics, Investment, Manuscript, Disopyramide, Obstruction, Assessment, Pivotal, CRL, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Medical imaging, Patient, HCM

SOUTH SAN FRANCISCO, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2023. Net loss for the second quarter was $128.6 million, or $1.34 per share, compared to net loss for the second quarter of 2022 of $19.8 million, or $0.23 per share. Cash, cash equivalents and investments totaled $592.6 million at June 30, 2023.

Key Points: 
  • Completed Enrollment in SEQUOIA-HCM, Pivotal Phase 3 Trial of Aficamten in Obstructive HCM; On Track for Topline Results by the End of the Year
    ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Non-Obstructive HCM, Expected to Start in September 2023
    SOUTH SAN FRANCISCO, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2023.
  • Net loss for the second quarter was $128.6 million, or $1.34 per share, compared to net loss for the second quarter of 2022 of $19.8 million, or $0.23 per share.
  • Cash, cash equivalents and investments totaled $592.6 million at June 30, 2023.
  • We are pleased with ongoing study conduct and expect topline results from SEQUOIA-HCM by year end,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer.