Hemodynamics

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).

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.

Orchestra BioMed Announces Presentation of Results from Clinical Study Demonstrating Favorable Hemodynamic Effects of AVIM Therapy In Hypertensive Pacemaker Patients

Retrieved on: 
Wednesday, March 6, 2024
Blood pressure, PV, HOPE, Beat (music), Overalls, Cardiac output, Stroke, Safety, Hypertension, Aorta, Patient, Hemodynamics, RV, DDD, Heart failure, Medical device

These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.

Key Points: 
  • These data demonstrate the favorable impact of AVIM therapy compared to standard right ventricular (RV) pacing on systolic blood pressure and overall cardiac function when delivered using both conduction system andstandard pacing lead locations.
  • The PV loop study was conducted at Na Homolce Hospital in Prague by Prof. Petr Neužil, M.D.
  • AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure.
  • “Well-conducted invasive PV loop studies are a robust way to evaluate the impact of a novel therapy like AVIM on hemodymanics and overall cardiac function.

Cytokinetics Presents New Data at CMR 2024 From FOREST-HCM, the Open Label Extension Clinical Trial of Aficamten

Retrieved on: 
Thursday, January 25, 2024
Tricuspid valve, Patient, Architecture, Fibrosis, Heart, Hemodynamics, CMR, SAN, Sudden death, Pulmonary fibrosis, LVEF, Research and development, Hypertrophic cardiomyopathy, Disease, Cytokinetics, LVOT, Research, Week, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM).
  • At the time of this analysis, 16 patients in FOREST-HCM had completed a CMR at baseline and at Week 48.
  • Baseline characteristics of the CMR cohort were comparable to the overall patient population in FOREST-HCM.
  • We look forward to expanding on these data in the future.”

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.

Pi-Cardia Hires Gary Gratson to Lead Global Commercialization

Retrieved on: 
Monday, December 11, 2023
Cardiology, Biotechnology, Other Communications, Health, Marketing, Medical Devices, Communications, Other Health, TAVR, Heart, TMVR, Risk, Percutaneous aortic valve replacement, Patient, Multimedia, Hemodynamics, Aortic stenosis, Growth, Physician, 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 hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) 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 hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) 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.
  • In his new role, Mr. Gratson will be responsible for building and leading the US commercial organization, driving strategic initiatives, and contributing to the continued growth of Pi-Cardia.
  • "I am honored to join Pi-Cardia at such exciting times,” said Mr. Gratson.

Late-Breaking Clinical Trial Results Announced at The VEINS 2023

Retrieved on: 
Monday, October 30, 2023
Trial of the century, RCT, Male, The, Thrombolysis, Dexamethasone, VIVID, PE, DVT, Hemodynamics, BPM, Deep vein thrombosis, PTS, VIVA, Safety, Patient, Ageing, Contraindication, Heart rate, CTA, Research, Quality of life, Syndrome, Anesthesia, Education, Villalta, USP, Freedom, Randomized controlled trial, Wynn Las Vegas, Birth control, Medical imaging, Pharmaceutical industry, Akura, Bullfrog

Below are highlights of this morning's 4 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 4 late-breaking clinical trial presentations.
  • These favorable clinical outcomes highlight the need for randomized controlled trial data comparing MT with standard of care anticoagulation treatment.
  • In the second phase of the trial, 60 participants will be enrolled 1:1 in a dual-blinded, randomized controlled trial (RCT).
  • Of the 21 patients followed at 1 month, 19 (90.5%) had fully compressible and two had partially compressible common femoral veins.

Edwards MITRIS RESILIA Valve Receives CE Mark for Mitral Replacement Surgeries

Retrieved on: 
Thursday, October 26, 2023
Health, Medical Devices, Managed Care, Research, Science, Pharmaceutical, Biotechnology, FDA, Long-term care, Edwards, Multimedia, Senior, Fluoroscopy, Quality of life, Disease, Hemodynamics, Freedom, Mitral valve, Patient, CE marking, Medical imaging

Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position.

Key Points: 
  • Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position.
  • The MITRIS RESILIA valve is made with innovative bovine pericardial tissue technology that reduces calcium build up on the valve.
  • View the full release here: https://www.businesswire.com/news/home/20231025088486/en/
    The MITRIS RESILIA valve is made with innovative tissue technology RESILIA allowing the valve to potentially last longer than conventional bioprosthetic valves.
  • * (Photo: Business Wire)
    The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve.

Shifamed Innovation Hub to be Prominently Featured at TCT 2023

Retrieved on: 
Thursday, October 19, 2023
Coronary thrombosis, Sale, Shark Tank, Use, University College, Oxford, Interest, MCS, Thrombectomy, Coronary artery disease, Ecosystem, Hemodynamics, Heart Institute, University of São Paulo, Cost, TCT, Patient, VTE, Pharmaceutical industry

CAMPBELL, Calif., Oct. 19, 2023 /PRNewswire/ -- Shifamed LLC, a highly specialized medical innovation hub, and its portfolio companies will be showcasing their latest cardiovascular solutions during the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco, October 23-26.

Key Points: 
  • Cardiovascular portfolio companies to be highlighted in a live case, clinical data presentations, and Shark Tank Innovation Competition
    CAMPBELL, Calif., Oct. 19, 2023 /PRNewswire/ -- Shifamed LLC , a highly specialized medical innovation hub, and its portfolio companies will be showcasing their latest cardiovascular solutions during the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco, October 23-26.
  • "Shifamed has built an ecosystem where we design and develop next-generation medical products that aim to improve clinical standards and positively impact patients' lives," said Amr Salahieh, President & CEO, Shifamed.
  • The Akura Medical System is for Investigational Use only and is not for sale in the U.S. or outside the U.S.
  • The Supira System is for Investigational Use only and is not for sale in the U.S. or outside the U.S.

Expert Panelists Advocate Use of Daxor’s Technology to Optimize Treatment at Heart Failure Society of America Annual Scientific Meeting

Retrieved on: 
Friday, October 13, 2023
Pressure, Hemodynamics, Clinical professor, Mayo Clinic, Duke University Hospital, Plasma, Proxy, Hospital, BVA, Mortality, Congestion, OH, Duke University Health System, Huntington Convention Center of Cleveland, Phenotype, Patient, Medical device, Heart failure

Oak Ridge, TN, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces that experts recommend the use of blood volume analysis (BVA) to guide optimal treatment in heart failure patient at two Scientific Sessions held during the Heart Failure Society of America Annual Scientific Meeting on October 8th & 9th, 2023, at the Huntington Convention Center in Cleveland, OH.

Key Points: 
  • The first session, titled, “Managing Congestion: Targeting Pressure vs. Volume,” was co-moderated by Dr. Arvind Bhimaraj, Houston Methodist DeBakey Heart and Vascular and Dr. Marat Fudim, Duke University Health.
  • Panel members including Dr. Wayne Miller, Mayo Clinic, Dr. Brian Howard, Wellstar, and Stephanie Barnes, CHFN, Duke University Hospital all called for the routine use of BVA to improve heart failure care.
  • Clinical use of blood volume analysis was highlighted through patient case studies presented by Dr. Howard and Stephanie Barnes.
  • Panel member Dr. Maria Rosa Constanzo, Midwest Cardiovascular Institute, stated, “assessment of congestion is complex,” and stressed the importance of monitoring congestion early before hospitalization.