”MitraClip was first implanted in 2003, obtained the CE mark Europe in 2008, and in 2013 was approved by the FDA. The FDA obligated the company to run post-marketing studies to confirm the safety and efficacy of the device.”
I think this is the report on those post-marketing studies.
Also, compare ”The device itself costs about $30,000” with http://www.onlinejacc.org/content/accj/60/17_Supplement/B229..., which says the device is only cost effective at that price for “patients with acute procedural success”. I don’t know what “acute procedural success” means. Taking it literally it would mean that excludes patients for whom the operation wasn’t deemed a success immediately after the operation, but that would seem like cheating to me. By such logic, roulette would bring all players profits.