• 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
      Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

      Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

      CRISPR Combined with Glowing Proteins for Viral Detection

      CRISPR Combined with Glowing Proteins for Viral Detection

      Biomimetic Construct Models Burn Injuries

      Biomimetic Construct Models Burn Injuries

      Moving Cells Using Ultrasound

      Moving Cells Using Ultrasound

    • Radiology
      Imaging Technique Reveals Contraction Patterns During Labor

      Imaging Technique Reveals Contraction Patterns During Labor

      Moving Cells Using Ultrasound

      Moving Cells Using Ultrasound

      Ultrasound Catheter to Treat Hypertension

      Ultrasound Catheter to Treat Hypertension

      Antibacterial Smart Sutures Visible in CT Scans

      Antibacterial Smart Sutures Visible in CT Scans

    • Cardiology
      Scientists Grow Electrodes Inside The Body

      Scientists Grow Electrodes Inside The Body

      Patient-Specific Soft Robotic Heart Replicas for Treatment Planning

      Patient-Specific Soft Robotic Heart Replicas for Treatment Planning

      Tiny Patch for Cardiac Ultrasound Imaging

      Tiny Patch for Cardiac Ultrasound Imaging

      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

    • Surgery
      Biomimetic Construct Models Burn Injuries

      Biomimetic Construct Models Burn Injuries

      Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

      Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

      Self-Assembling Peptides as a Bioink

      Self-Assembling Peptides as a Bioink

      3D Bioengineered Skin Grafts Fit Complex Anatomy

      3D Bioengineered Skin Grafts Fit Complex Anatomy

    • Nanomedicine
      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

      Extra Hot Nanoparticles for Cancer Therapy

      Extra Hot Nanoparticles for Cancer Therapy

      Making Tumors Tastier for the Immune System

      Making Tumors Tastier for the Immune System

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Improved Membrane Coating for Anti-Cancer Nanoparticles

    • Military Medicine
      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

      Fabric Makes Electricity from Movement to Power Wearables

      Fabric Makes Electricity from Movement to Power Wearables

      Wearable Uses Microneedles to Track Metabolism

      Wearable Uses Microneedles to Track Metabolism

    • Rehab
      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Non-Invasive Spinal Modulation for Cerebral Palsy

  • 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

Direct Flow Medical Transcatheter Aortic Valve Does Well in Clinical Study

November 2nd, 2012 Medgadget Editors Cardiac Surgery, Cardiology, Vascular Surgery

Direct Flow Medical (Santa Rosa, CA) reported initial results of a clinical study of its Transcatheter Aortic Valve System that met its primary mortality endpoint and that “greater than 95 percent of patients had mild or less aortic regurgitation, and no patients experienced vascular complications.”

The valve is made of a polymer frame, bovine pericardium leaflets, and two inflatable rings that sit on both sides of the patient’s own valve, completely taking over its space. Because the rings can deflate as well, the valve can be easily repositioned for a better fit or removed if complications occur.

Some of the findings reported from the study:

The DISCOVER Trial is a prospective, multicenter study of up to 100 patients conducted at 10 European sites of patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair. The device studied was the Direct Flow Medical Transcatheter Aortic Valve System, which is endovascularly delivered via an 18F introducer sheath. The trial was initiated in November 2011 and the first patient was treated at the L’Institut Jacques Cartier in Massy, France by Co-Principal Investigator Thierry Lefevre, MD.

In the presentation of 30 day results for the pre-specified CE Cohort of 33 patients reported by Co-Principal Investigator Joachim Schofer, MD from the Medical Care Center, Hamburg, Germany, all patients were successfully treated via a transfemoral approach using the low profile, flexible Direct Flow Delivery System. The primary endpoint, freedom from all-cause mortality from procedure to 30 days, was met at 97 percent. Freedom from all cause cardiovascular mortality at 30 days was 100 percent.

Importantly, the Direct Flow Valve resulted in 97 percent mild or less aortic regurgitation, with 81 percent of patients experiencing none/trace aortic regurgitation as reported by the study Corelab. There were no major vascular complications in any patients post-procedure through 30 days even though the minimum vessel diameter treated in the study was 5.2 mm. The mean gradient pre-procedure to discharge and out to 30 days of 46.0, 13.6 and 12.9 mmHg, respectively, demonstrated the ability to significantly reduce gradients over time. All hemodynamic results were analyzed by an independent imaging core laboratory.

Product page: Direct Flow Medical percutaneous aortic valve

Press release: Direct Flow Medical® Transcatheter Aortic Valve System Shown To Virtually Eliminate Aortic Regurgitation With No Vascular Complications In DISCOVER CE
Mark Trial

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
Venture builder BHV Partners launches Conus Airway to improve anaesthesia  and respiratory surgery

Venture builder BHV Partners launches Conus Airway to improve anaesthesia and respiratory surgery

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

machineMD and Varjo revolutionize the diagnosis of brain disorders with a VR-based eye-tracking solution 

machineMD and Varjo revolutionize the diagnosis of brain disorders with a VR-based eye-tracking solution 

Ax-Surgi Hemostat gets FDA Clearance for Surgical Bleeding Control

Ax-Surgi Hemostat gets FDA Clearance for Surgical Bleeding Control

Clarius Report Finds 85% of Clinicians Believe Ultrasound Leads to Better Patient Outcomes

Clarius Report Finds 85% of Clinicians Believe Ultrasound Leads to Better Patient Outcomes

interviews & reviews
Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Alpha TAU Killing Tumors With Highly Targeted Alpha Radiation

Alpha TAU Killing Tumors With Highly Targeted Alpha Radiation

Neuroimmune Modulation for Inflammatory Disease: Interview with Dr. Simhambhatla, President and CEO of SetPoint Medical

Neuroimmune Modulation for Inflammatory Disease: Interview with Dr. Simhambhatla, President and CEO of SetPoint Medical

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

  • 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!
Posting....
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email