Forbes is not exactly a medtech publication. It’s fascinating therefore to see it covering the story of how an investigator in Medtronic’s CoreValve study has fallen foul of the FDA. The cardiologist involved is one Dr Michael Ring of the Providence Sacred Heart Medical Center, in Spokane, WA. It seems the agency has taken umbridge at a number of procedural shortcomings, including a failure to get consent and failure to report patient deaths through the appropriate channels.
The Forbes piece can be found here.
What we find fascinating, from our European vantage point, is that by having the requirement for a clinical trial to support a product, and for that trial to be performed under the auspices of the regulator, all of these alleged misdemeanours are transparent and available for us to peruse and make up our own mind about. We think there are lessons for Europe as it continues to debate the future regulatory requirements.
Source: Forbes
published: March 1, 2013 in: Cardio, Clinical Studies/Trials, Medtronic