Showing posts with label FDA study. Show all posts
Showing posts with label FDA study. Show all posts

Friday, December 27, 2013

TOCA is pleased to announce that David S Bailie MD has been selected as a principal investigator of a new stemless total shoulder replacement device.

TOCA is pleased to announce that David S Bailie MD has been selected as a principal investigator of a new stemless total shoulder replacement device. This is a randomized study being conducted at 12 FDA approved medical facilities in the US. Dr. Bailie is the only orthopedic surgeon approved to use this device in the western US (west of  Memphis, TN). 

This FDA approved study is being sponsored by Biomet Orthopedics ( a worldwide manufacturer/distributor of Orthopedic devices, www.Biomet.com). 

Dr. Bailie has been selected by the FDA and the Western Institutional Review Board to participate and enroll qualified patients. The device has already been released and is currently being used in several European countries and the UK. Because the device is uniquely different than any current shoulder replacement on the market, in the US it requires a specifically designed FDA approved study, to be conducted by select surgeons, prior to general release to the remainder of the medical community. Until the study is complete (approximately 5-7 years), it will only be available as part of this study. Dr. Bailie is very excited to have been asked to participate in this "cutting-edge" research and be able to offer his patients a unique opportunity to participate. Participating orthopedic surgeons is by invitation only.

As criteria for patients to be included in this study is very specific and narrow, only those potential patients who are seen and examined personally by Dr. Bailie can be considered. This study will be performed under strict FDA and IRB monitoring until it is completed.



TOCA
602-277-6211
www.tocamd.com

Tuesday, January 22, 2013

Nano Shoulder Replacement

Physician News: Dr. David Bailie







Nano Shoulder replacement


An FDA approved study for the Nano Shoulder Replacement is to begin soon. Only 12 Doctors in the US are allowed to participate in this study. Dr. David Bailie is the only physician in the Southwest. This is a new stemless total shoulder system of which Dr. Bailie is a a co-designer. This device is made by Biomet- one of the largest worldwide Ortho implant companies. Co-designers are docs at Mayo-Rochester, Johns Hopkins and University of Toronto.


This shoulder implant was released for use in Europe fall 2012 and surgeons from Italy, France, Germany are stating they love it and are switching to use it exclusively.  Hundreds have been placed. The Start date of the FDA study is currently unknown but sometime mid-late 2013.

Dr. Bailie is currently looking for patients who would like to participate in this FDA shoulder replacement study. The only way for a shoulder patient to receive this devices for the next 3 years will be through the FDA study, and will not be available to other surgeons not participating until the study is concluded. 


To read more about Dr. Bailie please visit: www.tocamd.com or http://sportsmeddoc.com/