• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—Sept. 23

    Beckman Coulter Helping Labs Comply With Annex 1 Regulation

    FDA Clears MeMed BV Direct From Whole Blood

    Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability

    EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Cirtec Medical

    NDH Medical Inc.

    JBC Technologies

    Halkey-Roberts Corporation

    Johari Digital Healthcare Ltd.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    NDH Medical Inc.

    JBC Technologies

    Halkey-Roberts Corporation

    Johari Digital Healthcare Ltd.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Approves Cardiva Medical's VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure

    Potential procedures include cardiac ablation and left atrial appendage closure, among others.

    FDA Approves Cardiva Medical
    VASCADE MVP Venous Vascular Closure System. Image courtesy of Cardiva Medical Inc.
    Business Wire02.04.19
    Cardiva Medical Inc., an innovator in the field of vascular closure, has received PMA approval from the U.S. Food and Drug Administration (FDA) for the VASCADE MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed and labeled specifically for multi-site venous closure— for 6-12 French inner diameter sheaths. This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure.
     
    VASCADE MVP uses a simple and proprietary delivery system to place a collagen patch on the outside of each vessel puncture site following completion of the procedure. Nothing is left behind inside the vessel, and the collagen outside the vessel wall is resorbed in a short period of time enabling reaccess for future procedures.

    “We are at the dawn of a new era now for electrophysiology procedures with this trailblazing technology,” said Suneet Mittal, M.D., director of electrophysiology and medical director of The Snyder Center for Comprehensive Atrial Fibrillation at The Valley Hospital in Ridgewood, N.J. “The improvements we have seen in both patient satisfaction and more efficient hospital workflow make this one of those rare new technologies that produces benefits for all stakeholders.”
     
    The approval is based on results of the AMBULATE Pivotal Trial, a 204-patient, 13-site randomized, controlled study of the VASCADE MVP System compared to standard manual compression following cardiac ablation. The study showed significant improvements in time to ambulation, total post-procedure time and time-to-discharge eligibility, as well as improved patient satisfaction scores and reduced use of opioid pain medications. Results of the trial were presented at the 2018 AHA Scientific Sessions by Andrea Natale, M.D., co-principal investigator and executive medical director, Texas Cardiac Arrhythmia Institute in Austin, Texas.
     
    “With the VASCADE MVP device, we have been able to get patients safely on their feet hours earlier than previously possible after an ablation for atrial fibrillation or a left atrial appendage closure procedure,” said Amin Al-Ahmad, M.D., electrophysiologist at Texas Cardiac Arrhythmia Institute. “In our practice the new Cardiva workflow has freed up staff and beds—and patient satisfaction has skyrocketed with less time spent immobilized on their backs. This new workflow may also make it possible to send more patients home the same day as their procedure.”
     
    “Approval of the VASCADE MVP System marks the culmination of a multi-year effort by Cardiva to pioneer the first dedicated vessel closure solution for electrophysiology procedures such as cardiac ablation and left atrial appendage closure,” said John Russell, CEO of Cardiva Medical. “We are proud to have partnered with leading EP physicians in the United States to address this unmet need—and enable patients to get back on their feet sooner and improve the workflow for these highly successful procedures. This approval—our second PMA approved product—is an exciting milestone for our team, and shipments to leading centers in the United States have already begun.”
     
    VASCADE MVP is a new vessel closure device designed specifically for electrophysiology procedures and built upon the established and clinically proven VASCADE system, which has been used with over 300,000 patients.
     
    A fully integrated, extravascular, bioabsorbable femoral access closure system, VASCADE MVP is easy to use and leaves no permanent components behind. The system combines Cardiva’s proven proprietary collapsible disc delivery system and a thrombogenic resorbable collagen patch in an integrated design.
     
    VASCADE MVP works by placing a small, collapsible mesh disc against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue tract and then removing the mesh disc. The collagen patch expands, providing a mechanical and physiological seal to stop the bleeding, and then absorbs into the body, leaving nothing behind and allowing further access to the vessel if additional procedures are required.
     
    VASCADE MVP is indicated for percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6-12F inner diameter procedural sheaths, with single- or multiple-access sites in one or both limbs.
     
    The AMBULATE study was a randomized, controlled clinical trial that enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the United States. All patients had multiple (3 or 4) mid-bore (6-12 Fr inner diameter sheath) femoral venous access sites, and were randomized into one of two groups. The treatment group had all sites closed with the VASCADE MVP system, while the control group had all sites closed using manual compression, which is the current standard of care. Patients were enrolled with both radiofrequency and cryo energy sources used in their procedures. Principal investigators include Andrea Natale, M.D.; Mintu Turakhia, M.D., associate professor, Stanford University School of Medicine; and Steve Compton, M.D., Alaska Heart and Vascular Institute.

    Compared to manual compression, the Vascade MVP System met all primary and key secondary endpoints, including:
    • Time to Ambulation (primary endpoint). A measure of how quickly patients are able to get up on their feet and walk following vessel closure. The VASCADE MVP arm showed a median reduction of 3.9 hours (2.2 hours vs. 6.1 hours, p-value < 0.0001).
    • Total Post-Procedure Time. The VASCADE MVP arm showed a mean reduction of 3.7 hours in the total time from completion of the ablation procedure to the patient walking. This was inclusive of the time to achieve vessel closure (3.1 hours vs. 6.8 hours, p-value <0.0001).
    • Time-to-Discharge Eligibility. VASCADE MVP reduced the mean time for patients to be deemed eligible for discharge by 3.4 hours (3.1 hours vs. 6.5 hours, p-value < 0.0001).
    • Patient Satisfaction. The patient-reported level of satisfaction with the duration of bed rest was 63 percent higher in the VASCADE MVP arm (8.3 score out of 10 vs. 5.1 out of 10, nominal p-value <0.0001).
    • Opioid Pain Medications. 58 percent fewer patients in the VASCADE MVP arm used opioid-class pain medications following their procedure (15 percent of patients vs. 36 percent of patients, nominal p-value 0.001).

    Additional studies in the industry-leading AMBULATE series include:
    • AMBULATE IMPACT Study: A recently completed study that examines today’s workflow following ablation procedures with a focus on improving hospital economics through early patient ambulation and improved workflow. Results from the AMBULATE IMPACT study will be published in 2019.
    • AMBULATE CAP Study: A continued access protocol study designed to evaluate the safety of VASCADE MVP with earlier hospital discharge, elimination of urinary catheters, and elimination of protamine drug use in the setting of electrophysiology procedures. The AMBULATE CAP protocol recently completed enrollment with 168 patients enrolled at three centers.
    Cardiva Medical Inc. is a privately held medical device company focused on developing and commercializing vascular closure technologies. The company is headquartered in Santa Clara, Calif.

    VASCADE and Cardiva Catalyst and VASCADE MVP are registered trademarks of Cardiva Medical Inc.
    Related Searches
    • technology
    • bioabsorbable
    • safety
    • electrophysiology
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review
    Chief Financial Officer at Senseonics Holdings to Retire Chief Financial Officer at Senseonics Holdings to Retire
    FDA FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance
    CardioMech Appoints President and CEO CardioMech Appoints President and CEO
    Retia Medical’s Argos Cardiac Output Patient Monitor Cleared Retia Medical’s Argos Cardiac Output Patient Monitor Cleared
    Hologic’s Cynosure Division Launches TempSure Surgical RF Technology Hologic’s Cynosure Division Launches TempSure Surgical RF Technology
    AVITA Medical Begins Clinical Study of RECELL System in Pediatric Burn Treatment AVITA Medical Begins Clinical Study of RECELL System in Pediatric Burn Treatment
    Hill-Rom & EarlySense Launch Patient Monitoring Technology for Centrella Smart+ Beds Hill-Rom & EarlySense Launch Patient Monitoring Technology for Centrella Smart+ Beds
    Subtle Medical Subtle Medical's SubtlePET Gains FDA Clearance & CE Mark
    First Patient Treated in Medtronic First Patient Treated in Medtronic's TERMINATE AF Clinical Trial
    Deciphering Dosage: A Focus on Combination Products Deciphering Dosage: A Focus on Combination Products
    MPO Summit: The View from the Top MPO Summit: The View from the Top
    RSNA News: Siemens Healthineers Debuts MAGNETOM Altea 1.5T MR Scanner RSNA News: Siemens Healthineers Debuts MAGNETOM Altea 1.5T MR Scanner
    New Efforts to Strengthen FDA’s Expanded Access Program New Efforts to Strengthen FDA’s Expanded Access Program

    Related Breaking News

    • Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review

      Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review

      The 510(k) program must keep pace with the important innovations FDA is seeing in device development.
      Scott Gottlieb, M.D., Commissioner; Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health;, U.S. Food and Drug Administration 01.23.19

    • Chief Financial Officer at Senseonics Holdings to Retire

      Chief Financial Officer at Senseonics Holdings to Retire

      Executive will remain with the company until a replacement is found.
      Business Wire 01.21.19

    • Digital Health | Software & IT
      FDA

      FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program

      The program aims to promote a more efficient framework for the review of safe and effective digital health innovation.
      Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 01.08.19


    • Patient Monitoring
      Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance

      Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance

      Bruin Biometrics' SEM Scanner directs clinicians to heels and sacrums at risk of developing pressure ulcers, even before the damage is visible.
      PR Newswire 01.03.19

    • Cardiovascular
      CardioMech Appoints President and CEO

      CardioMech Appoints President and CEO

      Company chooses 28-year medtech veteran as board chairman.
      Business Wire 12.18.18

    Loading, Please Wait..

    Trending
    • A New Approach To Post-Market Surveillance
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Cochlear Implant Study Underway At Mayo Clinic
    • MPO's Most-Read Stories This Week—Sept. 16
    Breaking News
    • MPO's Most-Read Stories This Week—Sept. 23
    • Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    • FDA Clears MeMed BV Direct From Whole Blood
    • Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
    • EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Superior Subtractive Solutions for Machining Medtech
    • Medical Device Industry Experts' Thought on Assembly & Automation
    • Power Trip: A Discussion of Custom Medical Electronics
    • The MDR Transition: An Opportunity for Design Change?
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    GOED Releases Sustainability Report for Omega-3s Industry
    ABC’s Journal HerbalGram Celebrates 40th Anniversary
    Curcumin May Be As Effective as PPI for Indigestion
    Coatings World

    Latest Breaking News From Coatings World

    Śnieżka Group Results are Above Expectations in 1H 2023
    ACS Reports Chameleon Inspired Building Coating
    Substrate Wetting Agent Available from BRB International
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Sept. 23
    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    FDA Clears MeMed BV Direct From Whole Blood
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Eftilagimod Cleared for Clinical Trial Use in the UK
    Veranova Names William Sanders Global VP of Chemical Development Ops
    Chime, Panolos Partner to Advance Multi-specific Therapeutic Proteins
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Hailey Bieber's Rhode Expands Into Makeup
    Avon Enters Retail Partnership with Superdrug
    IT Award Winners Announced at MakeUp in NY
    Happi

    Latest Breaking News From Happi

    Natural Products Expo East Tradeshow Closes
    Color Street Launches ‘Don’t Be Afraid’ Halloween Nail Art Collection
    Dental Care Trends and SBLA Beauty's Advertising Claims Under Scrutiny
    Ink World

    Latest Breaking News From Ink World

    Cooper Watson Acquires Tower Products
    The Durst Group Awarded Eight 2023 PRINTING United Alliance Pinnacle Awards
    Weekly Recap: Wikoff Color, HP, INX VC Top This Week’s Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PRX Market debuts, Tower Products acquired and more
    Flexo Wash to exhibit at FTA Fall Technical Conference
    Recyclable, deinkable stand-up pouch wins Gold in Germany
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Soft N' Dry Seeks to Expand Private Label Roll Out, Albis Completes Work on Line
    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Completes Work On Extra Wide Carding, Blending Line
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Sept. 23
    Anika Releases RevoMotion Reverse Shoulder Arthroplasty System
    Exactech's Activit-E Polyethylene OK'ed for Vantage Total Ankle
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    HID to Showcase Future-Proof Solutions at GITEX 2023
    Weekly Recap: Mergers and Acquisitions, IEC’s IME Standards Top This Week’s Stories
    EU-Funded Collaboration Hub Aims to Mainstream Printed Electronics

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login