510(k) Is Dead—Long Live Medtronic's Review Agreement with Yale?

Medtronic Inc. (Minneapolis) recently reported that it is providing a grant to Yale University (New Haven, CT) to conduct two fully independent, third-party systematic reviews of the safety and effectiveness of its controversial Infuse recombinant bone morphogenic protein-2 (rhBMP-2) product, which has been linked to the increased risk of male infertility. In light of the conclusion by the Institute of Medicine (IOM; Washington, DC) that the FDA 510(k) review process is broken beyond repair, Medronic's decision to seek independent review of its problematic recombinant bone product is noteworthy.

According to the agreement between Medtronic and Yale, the company will provide the university with all available patient-level data on rhBMP-2 from Medtronic-sponsored clinical trials and all FDA-filed adverse event reports. Yale will assemble a panel of experts and a commission consisting of two academically recognized clinical research organizations specializing in systematic reviews to conduct the analyses. Then, Medtronic will voluntarily make all of its clinical-trial results information on the product available publicly on ClinicalTrials.gov, the clinical-trial registry managed by the National Library of Medicine (Bethesda, MD). Finally, the company has agreed that Yale will develop a novel program to provide researchers access to all data on rhBMP-2--a program that is characterized as unprecedented in the medical device industry because it will provide access to Medtronic's full patient-level datasets.

That brings us back to the huge brouhaha surrounding the big "F" that the IOM has handed out to the decades-old 510(k) review process. In the orthopedics area alone, calamities not unrelated to the faulty review process abound, forcing one company after another to recall a variety of orthopedic implants. Unforgotten are Stryker's 2008 recall of its Trident PSL and hemispherical acetabular hip replacement cups and Johnson & Johnson DePuy's recall last year of its ASR XL acetabular system and its ASR hip-resurfacing system.

Will Medtronic's agreement with Yale University to review the company's Infuse bone-graft technology make a difference? Should it be viewed as some sort of replacement for the 510(k) regime? Or, since Medtronic is footing the bill for the Yale review, is it merely another variant of the fox guarding the henhouse? It's too early to tell, but all eyes will be on Medtronic and Yale to see what comes of this arrangement. --Bob Michaels