Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Sponsor-Investigator Trials Provide Avenue For Firms To Expand Device Uses

This article was originally published in The Gray Sheet

Executive Summary

Physician studies of W.L. Gore's Helex septal occluder, used in the closure of atrial septal defects, demonstrate that the device can also close patent foramen ovale (PFO) for prophylaxis of recurrent paradoxical embolism and embolic stroke

You may also be interested in...



FDAMA In Action? ODE Shows Progress On IDE Supplements, Five-Day Notice

The Center for Devices and Radiological Health is addressing industry concerns over FDA's handling of increasing numbers of investigational device exemption supplements and use of the agency's five-day notice program for clinical trial changes

FDAMA In Action? ODE Shows Progress On IDE Supplements, Five-Day Notice

The Center for Devices and Radiological Health is addressing industry concerns over FDA's handling of increasing numbers of investigational device exemption supplements and use of the agency's five-day notice program for clinical trial changes

NMT, AGA Medical Pursue PFO Indication Following Septal Defect Approvals

Nitinol Medical Technologies' CardioSeal approval for ventricular septal defects Dec. 5 paves the way for pursuit of expanded approval to treat the much larger population with patent foramen ovale, the firm says

Latest Headlines
See All
UsernamePublicRestriction

Register

MT015751

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel