«Not only do we believe that high - quality, randomized clinical trials are necessary to determine the safety of the Lariat device
for off - label procedures, but our analysis
raises broader issues with the FDA 510 (k) clearance protocol
for medical devices,» said study senior author Jay Giri, MD, MPH, assistant professor in the Cardiovascular Medicine Division at Penn. «We believe there needs to be a method
for reassessing the safety of a device that has been cleared
for one use but is being frequently used
for a different
purpose in real - world practice.»
In fact, the miss - use of technology and science in general is challenged, especially in the way research designed
for medical purposes can be misappropriated, as seen in a subplot that evokes the moral quandaries
raised in Michael Apted's Extreme Measures (1996).