Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

NMT Looking To Broaden STARFlex Indication In Wake Of Panel Outcome

This article was originally published in The Gray Sheet

Executive Summary

NMT Medical is in discussions with FDA on the design of a trial to support a general stroke-prevention indication for its STARFlex patent foramen ovale (PFO) occluder

You may also be interested in...



PFO Occluder Erosion, Post-Implant Thrombosis Indicate Caution Warranted

Post-implant problems associated with patent foramen ovale (PFO) and atrial septal defect (ASD) devices, including potential thrombosis and device erosion, need to be overcome before the technology can be universally applied, according to TCT participants

PFO Occluder Erosion, Post-Implant Thrombosis Indicate Caution Warranted

Post-implant problems associated with patent foramen ovale (PFO) and atrial septal defect (ASD) devices, including potential thrombosis and device erosion, need to be overcome before the technology can be universally applied, according to TCT participants

NMT Medical study

Enrollment in 1,600-patient pivotal trial to evaluate STARFlex septal repair implant to treat stroke and transient ischemic attack will commence following a meeting between FDA and company reps, slated for the end of March. Conditional clearance has been granted while the firm responds to follow-up questions. In September, NMT's device was deemed "not approvable" by an FDA panel due to study design issues (1"The Gray Sheet" Sept. 23, 2002, p. 14). In the new trial, half of patients will be treated with STARFlex and the other half will receive traditional medical therapy, NMT says...

Related Content

UsernamePublicRestriction

Register

PS100968

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