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

ITGI Signs Strategic Cooperation Agreement with Vascular Solutions to Commercialize ITGI’s Coronary Covered Stent in the U.S. Market

November 11, 2013 By Business Wire

ITGI (TASE:ITGI) announces today the initiation of its activity in the U.S. market. The company has signed a strategic cooperation agreement with U.S.-based Vascular Solutions, Inc. (NASDAQ:VASC), an international leader in the interventional cardiology device market. The companies will collaborate to complete a U.S. development program and apply to the Food and Drug Administration for approval under the Humanitarian Device Exemption (HDE) process for ITGI’s novel Aneugraft Dx coronary covered stent.

Upon approval, Vascular Solutions will distribute ITGI’s coronary stent in the U.S. for use in the treatment of perforations and dissections of native coronary arteries, coronary aneurysms, and diseased saphenous vein grafts.

Under the U.S. clinical development program, ITGI will be responsible for the pre-clinical research phase, while Vascular Solutions will be responsible for all communications with the FDA and the execution of the clinical study in the U.S. ITGI expects the U.S. development program to start during the first quarter of 2014 and expects the development and review process to take approximately two and a half to three years.

Aviv Lotan, the CEO of ITGI, stated that “The U.S. market is the key target market for the company’s products. In line with ITGI’s previous announcements, that the U.S. clinical development and regulatory review process will commence only with a strategic partner that would bear part of the costs and assist in advancing the process, we are happy to join forces with Vascular Solutions and are pleased with the confidence the company has expressed in our coronary stent. On top of the strategic cooperation with Vascular Solutions, ITGI will enjoy an indirect investment, as Vascular Solutions is taking up the costs involved in the clinical study which will be conducted in the U.S. We are hopeful that this cooperation will lead to the FDA HDE approval and the beginning of commercialization in the U.S. This is an additional step for the company in its strategy to enter new markets and increase the company’s product sales worldwide.” The coronary covered stent developed by ITGI (Aneugraft® Dx) is a unique stent that has been engineered to allow easy, convenient navigation and deployment, with a flexible delivery system that allows tracking through tortuous blood vessels. The marketing of the stent commenced in 2011 in Europe after receiving CE approval.

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
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

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