• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

      Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

      Implantable Bioreactor for Kidney Cells

      Implantable Bioreactor for Kidney Cells

      Etched Nanopillars Kill Bacteria, Fungi on Titanium Implants

      Etched Nanopillars Kill Bacteria, Fungi on Titanium Implants

      Cells Release Insulin in Response to Music

      Cells Release Insulin in Response to Music

    • Radiology
      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Portable and Radiation-Free Imaging with Magnetic Nanoparticles

      Portable and Radiation-Free Imaging with Magnetic Nanoparticles

      Imaging Technique Reveals Living Brain Tissue in its Complexity

      Imaging Technique Reveals Living Brain Tissue in its Complexity

      Wearable Ultrasound for Deep Tissue Monitoring

      Wearable Ultrasound for Deep Tissue Monitoring

    • Cardiology
      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      3D Printed Heart Muscle Beats

      3D Printed Heart Muscle Beats

      Wireless Patch Monitors, Paces Heart and then Biodegrades

      Wireless Patch Monitors, Paces Heart and then Biodegrades

      Photonic Radar Monitors Breathing from a Distance

      Photonic Radar Monitors Breathing from a Distance

    • Surgery
      Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

      Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

      Droplet Battery Harnesses Ionic Gradients for Bioelectronic Implants

      Droplet Battery Harnesses Ionic Gradients for Bioelectronic Implants

      Implantable Bioreactor for Kidney Cells

      Implantable Bioreactor for Kidney Cells

      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

    • Nanomedicine
      Nanorobots Release Reactive Oxygen Species to Kill Fungal Biofilms

      Nanorobots Release Reactive Oxygen Species to Kill Fungal Biofilms

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Optical Strain Sensors for Rehab

      Optical Strain Sensors for Rehab

      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Brain Computer Interface Decodes Speech and Facial Expressions

      Brain Computer Interface Decodes Speech and Facial Expressions

      Semi-Automated Manufacture of E-Skin Sensors

      Semi-Automated Manufacture of E-Skin Sensors

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

MitraClip Repair Device Showing Positive Results in Study

March 29th, 2010 Medgadget Editors Cardiac Surgery


Results of a clinical study evaluating Abbott‘s MitraClip percutaneous mitral valve repair device have recently been announced, and the company is touting the positive outcomes. The MitraClip, which already has European approval, is designed to be percutaneously transfemorally delivered, to grasp and fasten together the mitral leaflets in patients with functional and degenerative MR. As we have previously reported, if necessary, a second MitraClip may be placed, similar to what is done in surgical E2E repair, to increase valve coaptation. All these new positive results bring hope that the device could become a standard alternative option to traditional surgical valve repairs for mitral regurg, and so may prove to be a better approach for certain types of patients.
Here are details of the results from Abbott’s news release:
588588834.jpg

In the EVEREST II trials primary safety endpoint of major adverse events (MAEs) at 30 days, the MitraClip system demonstrated a superior safety profile (p<0.0001) compared to surgical repair or replacement (9.6 percent of MitraClip patients and 57.0 percent of surgery patients had an MAE). Major adverse events is defined as a composite of 12 pre-specified adverse events. In the primary effectiveness endpoint, the MitraClip device was non-inferior to surgery at one year (clinical success rate of 72.4 percent for MitraClip patients with successful initial treatment compared to a clinical success rate of 87.8 percent for surgery patients). With 95 percent confidence, the clinical success rate of the MitraClip device falls within 25.4 percent of the clinical success rate of the surgical control. In the primary effectiveness endpoint, the clinical success rate is defined as freedom from death, surgery for valve dysfunction and moderate to severe MR (greater than 2+) at one year in patients with successful initial treatment. At one year, the MitraClip procedure demonstrated meaningful clinical benefits in the following secondary endpoints in patients with successful initial treatment:

  • A reduction in the severity of MR, with 81.5 percent of patients improving to mild (grade 1+) or moderate (grade 2+) MR whereas at baseline 95.6 percent of patients had moderate-to-severe (grade 3+) or severe (grade 4+) MR (p<0.0001)
  • A reduction in both the volume (left ventricular diastolic volumes) and the diameter of the left ventricle heart chamber (left ventricular diastolic dimensions), indicating an improvement in heart function. Left ventricular diastolic volumes decreased a significant 13 percent (p<0.0001) and left ventricular diastolic dimensions decreased a significant 6.4 percent (p<0.0001) compared to baseline.
  • An improvement in symptoms, with 97.5 percent of patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II) [p<0.0001], whereas at baseline, 52.6 percent of patients had moderate symptoms (NYHA Functional Class III) or severe symptoms (NYHA Functional Class IV). Patients who are classified as NYHA Functional Class III or IV experience marked or severe limitations in physical activity.
  • Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 Survey (increase of 4.7 points in the physical quality of life score [p<0.0001] and increase of 5.8 points in the mental quality of life score [p<0.0001]).

  • Press release: New Data Demonstrates Abbott’s Investigational MitraClip® System Has Potential to be a Valuable Treatment Option for Patients with Mitral Regurgitation, the Most Common Heart Valve Condition…
    Flashbacks: Study Initiated to Trial Tiny MR Repair Clip; Percutaneous MitraClip System Debuts In Europe; The MitraClip

    Medgadget Editors

    Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

    Sponsored
    Clarius L20 HD3 Receives Highest Image Quality Ranking Among Five Point-of-Care Ultrasound Devices

    Clarius L20 HD3 Receives Highest Image Quality Ranking Among Five Point-of-Care Ultrasound Devices

    Viral Vector Manufacturing in Gene Therapy and Vaccine Development

    Health and Clean Air: Why Indoor Ventilation Matters

    Health and Clean Air: Why Indoor Ventilation Matters

    New Survey Finds Strong Consumer Preference for More Natural Hernia Repair Options

    MedTech Outlook 2023 for Latin America Released

    MedTech Outlook 2023 for Latin America Released

    interviews & reviews
    Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

    Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

    UV-Free Air Decontamination: Interview with Sorel Rothschild, VP at Quantum Innovations

    UV-Free Air Decontamination: Interview with Sorel Rothschild, VP at Quantum Innovations

    EarliPoint Evaluation System for ASD Diagnosis: Interview with Tom Ressemann, CEO of EarliTec Dx

    EarliPoint Evaluation System for ASD Diagnosis: Interview with Tom Ressemann, CEO of EarliTec Dx

    Visually Guided Uterine Biopsies in Physician’s Office: Interview with Allison London Brown, CEO of LUMINELLE

    Visually Guided Uterine Biopsies in Physician’s Office: Interview with Allison London Brown, CEO of LUMINELLE

    AI-Powered Pain Relief: Interview with Claire Smith, VP at Nevro

    AI-Powered Pain Relief: Interview with Claire Smith, VP at Nevro

    MISHA Knee Shock Absorber: Interview with Anton Clifford, CEO of Moximed

    MISHA Knee Shock Absorber: Interview with Anton Clifford, CEO of Moximed

    Shelf-Stable Breast Milk Powder: Interview with Dr. Vansh Langer, CEO at BBy

    Shelf-Stable Breast Milk Powder: Interview with Dr. Vansh Langer, CEO at BBy

    • Subscribe
    • Contact us
    • Submit
    • About
    • Back to top
    Medgadget

    Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

    • About
    • Editorial policies
    • Contact
    • Terms of Service
    • Privacy
    • Submit press release
    • Advertise
    © Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
    Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
    • Facebook
    • Twitter
    • LinkedIn
    • Reddit
    • Email