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

IDEV Technologies Announces Completion of SUPERB Clinical Trial Enrollment

June 2, 2011 By Bio-Medicine.Org

WEBSTER, Texas, June 2, 2011 /PRNewswire/ — IDEV Technologies,
Inc. (IDEV) today announced the completion of enrollment in the
SUPERB Trial, an FDA-approved IDE trial evaluating the use of
IDEV’s SUPERA® stent system for treatment of peripheral artery
disease in the superficial femoral artery (SFA).  Enrollment
was completed in May, making SUPERB one of the fastest enrolling
SFA trials.

The trial is a prospective, single-arm study of 258 patients at
49 U.S. sites, led by national co-investigators Kenneth Rosenfield,
M.D., of Massachusetts General Hospital in Boston and Lawrence
Garcia, M.D., of Steward’s St. Elizabeth’s Medical Center of
Boston.  The study objective is to demonstrate safety and
effectiveness of the SUPERA stent in treating obstructive disease
in the SFA.

Dr. Rosenfield summarized, “We are excited to complete
enrollment in this important trial, and will now focus our efforts
on patient follow-up and analysis.  Given the encouraging data
we’ve seen from Europe for the SUPERA stent, and given the stent’s
outstanding mechanical properties, we are anxious to finalize our
results. It has been a pleasure to work with the great team of
researchers, coordinators, and support staff on this trial.”

“Endovascular treatment of the SFA in particular has been
problematic for the millions of patients suffering from PAD in the
United States,” added Dr. Garcia.  “The unique radial strength
and flexibility of the SUPERA stent’s design may provide what has
been needed to successfully treat this challenging vessel.”

Dennis Donohoe, M.D., is IDEV’s Chief Medical Officer and has
served as a key liaison to the clinical site investigators
throughout the trial.  “Completing enrollment of more than 250
pivotal patients in less than two years is a significant
achievement and reflects not only the caliber of our investigator
teams but also their confidence in this stent.  I congratulate
the team and look forward

‘/>”/>

SOURCE

Related Articles Read More >

A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies
Biotronik
FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
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