Medtronic has given a $2.5 million grant to Yale University to independently review the safety and effectiveness of its rhBMP-2 product, Infuse, which has recently been associated with more complications than initial company-funded studies reported, according to a North American Spine Society news release.
Studies and commentary published over the past two months in NASS' The Spine Journal have debated the effectiveness of the company-funded rhBMP-2 trials because, while complication rates were released to the FDA during the clearance process, they were not made available to the public. Additional independent research found that the protein was associated with higher levels of retrograde ejaculation than previously reported.
NASS cautiously applauded the move in the release, restating the organization's commitment to supporting full transparency between surgeons and device companies. Without knowing the specifics of the review process, The Spine Journal's Eugene Carragee, MD, says it is a "big first step in the right direction."
The Yale researchers will still be unable to fix the design flaws and assessment biases prevalent in the original studies. A previous randomized trail on the use of rhBMP-2 for posterior lumbar interbody fusion was never completed due to early complications and adverse events, therefore the new study will have very little controlled data to judge the actual safety of the project.
Read the release on the study of Infuse.
Related Articles on Infuse:
To Infuse or Not to Infuse: The Feud Between Spine Surgeons Continues
Infuse Lawsuits Begin: Negative Coverage Could Cost Medtronic Millions
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse
NASS cautiously applauded the move in the release, restating the organization's commitment to supporting full transparency between surgeons and device companies. Without knowing the specifics of the review process, The Spine Journal's Eugene Carragee, MD, says it is a "big first step in the right direction."
The Yale researchers will still be unable to fix the design flaws and assessment biases prevalent in the original studies. A previous randomized trail on the use of rhBMP-2 for posterior lumbar interbody fusion was never completed due to early complications and adverse events, therefore the new study will have very little controlled data to judge the actual safety of the project.
Read the release on the study of Infuse.
Related Articles on Infuse:
To Infuse or Not to Infuse: The Feud Between Spine Surgeons Continues
Infuse Lawsuits Begin: Negative Coverage Could Cost Medtronic Millions
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse