• 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
      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Medgadget Visits Healthcareᐩ Expo Taiwan

      Medgadget Visits Healthcareᐩ Expo Taiwan

    • Radiology
      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Fluorescence Imaging System Illuminates Tumor Depth

      Fluorescence Imaging System Illuminates Tumor Depth

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

    • Cardiology
      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

      Camera Measures Blood Pressure with Quick Look

      Camera Measures Blood Pressure with Quick Look

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

    • Surgery
      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Electrospun Construct Mimics Elasticity of Blood Vessels

      Electrospun Construct Mimics Elasticity of Blood Vessels

    • Nanomedicine
      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

      Magnetic Bacteria Target Tumors

      Magnetic Bacteria Target Tumors

    • 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
      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

      Implanted Magnets for Prosthetic Control

      Implanted Magnets for Prosthetic Control

  • 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

VASCADE Vascular Closure System Gets FDA PMA (w/video)

February 11th, 2013 Medgadget Editors Anesthesiology, Radiology, Vascular Surgery

VASCADE-Vascular-Closure-SystemCardiva Medical out of Sunnyvale, CA received FDA Premarket Approval (PMA) for the VASCADE Vascular Closure System, an extravascular device for speedy femoral arterial access site closure. The device is designed to induce hemostasis and close openings, without leaving anything inside the artery, created by size 5F, 6F, or 7F sheaths. It allows clinicians to re-access the site after closure and is meant to be painless to the patient. From the announcement:

Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression, the gold standard for vascular closure for patients undergoing percutaneous procedures through the femoral artery.

James Hermiller, M.D. of The Heart Center, Indianapolis, who served as Principal Investigator for the trial said, “I am extremely pleased with the outstanding clinical performance of VASCADE and with the extraordinary contributions by over 65 clinical investigators and their staff at over 20 clinical sites in the U.S and Australia who facilitated the study. With PMA approval, VASCADE will now be available in the U.S. to all physicians who need safe and effective vascular closure.”

VASCADE, an extravascular closure device, utilizes a unique delivery system based on a proprietary collapsible disc technology that provides temporary hemostasis during the procedure which eliminates the need for an intra-vascular component. Secure and rapid hemostasis is achieved with VASCADE by the deployment of a thrombogenic resorbable collagen patch at the arteriotomy of the femoral artery.

 

Product page: VASCADE Vascular Closure System

Press release: Cardiva Medical, Inc. Announces U.S. FDA Approval for VASCADE™ Vascular Closure System

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
New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

Fluidx Unveils New Embolic for Neurovascular Use

Fluidx Unveils New Embolic for Neurovascular Use

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

PT Genie Unveils New Brand Identity Reflecting Company’s Transformation and Focus on the Global Future of AI and Machine Learning in Digital Healthcare

Clarius Marketplace Unlocks the Power of AI Innovation for Ultrasound Imaging

Clarius Marketplace Unlocks the Power of AI Innovation for Ultrasound Imaging

interviews & reviews
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 

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

  • 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