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

FDA questioned on ProDisc

This article was originally published in The Gray Sheet

Executive Summary

University of California, Irvine spine surgeon, Charles Rosen, MD, sent a letter to CDRH Jan. 20 asking that an advisory panel be convened to assess the safety of Synthes' ProDisc lumbar artificial disc. His request stems from concerns about "the questionable results, and even dangerous consequences" of J&J/DePuy's Charité disc - the only artificial disc approved by FDA to date - including the quality of the study submitted to FDA, lack of information on adverse events and the implant's minimal ability to absorb shock. Synthes announced that ProDisc received an "approvable" letter from the agency Jan. 9. Prompted by a separate physician request, CMS is reviewing whether artificial lumbar discs should be nationally non-covered for Medicare beneficiaries (1"The Gray Sheet" Aug. 22, 2005, p. 3). The agency is expected to release a proposed decision memo Feb. 16...
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

MT023180

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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