Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

U.S. Clinical Trial to Begin for Large Bore Vascular Closure Device

July 8, 2016 By Essential Medical, Inc.

The FDA has granted Investigational Device Exemption approval to Essential Medical, Inc. to begin the U.S. clinical trial for MANTA, the company’s large bore vascular closure device.  

The pivotal study will evaluate the safety and efficacy of vascular access closure using MANTA for femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F.  

The device will be used to achieve safe, percutaneous closure in a variety of large bore procedures including transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair of abdominal aortic aneurysms, ventricular assist devices, and balloon aortic valvuloplasty.  

These large bore procedures are the fastest growing segment of the cardiovascular market and are driving a worldwide market for large bore vascular closure devices to exceed $600 million within the next five years.

Closure of large bore femoral access sites has been associated with significant increases in morbidity including longer times to achieve hemostasis, extended procedure time, higher rate of complications, and higher total cost of care.  

MANTA was specifically designed to address these complexities of closing large punctures in high-pressure vessels utilizing novel closure technology. Deployment of the device provides immediate hemostasis in order to reduce the complications and cost associated with large bore closure.  

“While transfemoral TAVR has advanced rapidly and can now be safely performed in fully awake patients in less than 30 minutes, the vascular closure method for these cases has not progressed and access site related complications remain a concern,” according to Dr. David Wood, an investigator for the U.S. MANTA trial and a founding member of the Centre for Heart Valve Innovation in Vancouver, Canada. “Safe, reproducible percutaneous large bore closure is needed before transfemoral TAVR can become the default strategy in most patients.”

Essential Medical, Inc. is a privately held medical device company addressing the large bore vascular closure market. The company was founded in 2010.

Related Articles Read More >

A portrait of Dr. Philip Adamson
Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
iRhythm stays silent on federal grand jury subpoenas
iRhythm stock soars on Street-beating Q1
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech