Structural heart disease

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.

Peerbridge Health's Remote Device for Early Detection of Heart Failure Achieves 95.7% Success Rate in Trial

Retrieved on: 
Tuesday, April 2, 2024
Diagnosis, Sepsis, Conference, Heart failure, Health, Patient, MD, Clinical trial, Cardiology, Heart, Structural heart disease, Medicare, ECG, St. Joseph's Hospital, Hospital, Pharmaceutical industry

NEW YORK, April 2, 2024 /PRNewswire/ -- Peerbridge Health, developer of a hospital-grade, remote diagnostic platform that harnesses AI to detect early signs of heart failure, today announced results of a recent feasibility trial showing its technology had a nearly 96% accuracy rate in identifying heart failure in patients utilizing ECG as the only input.

Key Points: 
  • Leveraging five-minute windows of electrocardiogram signals, the Peerbridge platform was able to determine whether an individual patient had heart failure (HFpEF or HFrEF) with 95.7% accuracy.
  • Heart failure is the second-leading cause of hospitalization in the U.S. (after sepsis) and the leading cause of hospitalization among adults 65 and older.
  • "The current diagnostic process for heart failure is slow and expensive," said Peerbridge Health CEO and President Chris Darland.
  • Detailed feasibility trial results will be presented at the 2024 Heart Rhythm Conference May 16-19 in Boston.

Teleflex Announces First Patient Enrollment in ACCESS-MANTA™ Registry

Retrieved on: 
Thursday, November 16, 2023
TAVR, Safety, NYSE, TFX, Cardiology, Structural heart disease, Patient, Registry, Interventional cardiology, Intervention, Hemostasis, SAFE, Teleflex, Doctor of Philosophy, Mount Sinai Medical Center, VCD, Mount Sinai Hospital (Manhattan), Medical device, Medical imaging, Hospital, Surgery, MD

The registry will include appropriate patient selection and proper vascular access.

Key Points: 
  • The registry will include appropriate patient selection and proper vascular access.
  • Enrolling at least 250 patients in up to 15 major TAVR institutions across the US and Canada, the ACCESS-MANTA™ Registry is an international, multicenter, prospective, observational, single-arm clinical registry.
  • “Large bore access site complications are recognized as morbid,1 driving increased costs and prolonged length-of-stay,2” said Teleflex Interventional Medical Director, Christopher Buller, MD.
  • “We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA™ Registry,” said Dr. Khera, Co-Global Principal Investigator.

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.

Recor Medical Announces U.S. Launch and First Commercial Cases of Paradise Ultrasound Renal Denervation Therapy

Retrieved on: 
Friday, November 10, 2023
Health, Medical Devices, General Health, Radiology, Clinical Trials, Cardiology, Biotechnology, Medicine, Arm, Food and Drug Administration, Disease, DRS, Hypertension, Food, M.B.B.S, RDN, Physician, Structural heart disease, Surgeon, Mortality, Cardiovascular disease, TRIO, Cleveland Clinic, Multimedia, Patient, Renal artery, Kaleida Health, Division, FDA, Master of Science, Gates Vascular Institute, Intervention, Biomedical sciences, University, MD, Doctor of Philosophy, Hospital, NewYork-Presbyterian Hospital, Blood pressure, Medical imaging, Pharmaceutical industry, Buffalo, Paradise

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States.

Key Points: 
  • Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States.
  • The first commercial procedures took place at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City by Drs.
  • Paradise uRDN delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves.
  • “This new renal denervation technology for a high-risk patient population – individuals with difficult to control hypertension – has been long awaited.

Abbott and Damar Hamlin Team Up to Build Heart Health Community with New HeartMates Program

Retrieved on: 
Tuesday, October 31, 2023
NYSE, Heart, Structural heart disease, Family, Medicine, Friends, Children's Hospital, Caregiver, Patient, Hospital, Hearing, Cardiovascular disease, Nursing, Medical device

The Abbott HeartMates program aims to create a community of support for people and caregivers impacted by heart conditions.

Key Points: 
  • The Abbott HeartMates program aims to create a community of support for people and caregivers impacted by heart conditions.
  • The program will enable participants to share stories and receive emotional support as well as connect with others going through similar heart health journeys.
  • Abbott is inviting people who are committed to inspiring others through their heart health stories to join Hamlin on our HeartMates team.
  • Team members will collaborate directly with Abbott and Hamlin as program ambassadors and promote the HeartMates community-building tenants to those impacted by heart conditions.

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."

Saranas Successfully Completes Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Retrieved on: 
Monday, September 18, 2023
Science, Cardiology, Research, General Health, Health, FDA, Clinical Trials, Other Health, Bleeding, De novo, Morristown Medical Center, Classification, BARC, Henry Ford Health, Structural heart disease, PCI, Incidence, Henry Ford, Patient, Impella, TAVR, Early Bird, MCS, Early, EVAR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Aortic stenosis, Food, Safety, Medical device, Birth control

The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.

Key Points: 
  • The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.
  • Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants.
  • The Early Bird Bleed Monitoring System is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.

HighLife Launches a New Large Annulus Valve in Ongoing Clinical Studies for Patients Suffering From Mitral Regurgitation

Retrieved on: 
Wednesday, September 6, 2023
Research, Medical Devices, Clinical Trials, Health Technology, Cardiology, Other Health, Biotechnology, General Health, Health, Science, Structural heart disease, LAV, LAV 6, MR, Mitral valve, Trial of the century, SAS, Clarity, Mitral regurgitation, LVOT, Patient, Risk, Highlife, Medical imaging, Pharmaceutical industry

HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today the introduction of a new valve size in its clinical trials, the Large Annulus Valve (LAV), designed for patients with larger anatomies.

Key Points: 
  • HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today the introduction of a new valve size in its clinical trials, the Large Annulus Valve (LAV), designed for patients with larger anatomies.
  • Among patients with moderate to severe MR, there has been a lack of treatment options for patients with large annuli.
  • “HighLife’s solution and this new valve size are a game-changer for our patients with Mitral Regurgitation.
  • We look forward to enroll and treat more patients in HighLife’s clinical study !”
    “We are excited to launch the Large Annulus Valve.