The FDA and Medicare apparently contrived to slow the adoption of a pioneering replacement heart valve, fearing too many seniors on Medicare would seek out the procedure, according to this WSJ report. The innovative medical device acts as an artificial replacement for the body's own aortic valve that is situated between the left ventricle and aorta within the human heart. But an ingenious medical device now allows the heart to be repaired using a catheter that introduces a replacement valve through a main artery in the leg—another miracle of modern medicine. This valve controls the flow of blood away from the heart; however, it starts to narrow as part of the ageing process, reducing the flow and thus leading to heart failure, and it some cases, death. Although open-heart surgery is typically the only other treatment option - an operation not without it's risks and associated costs, bureaucrats apparently eschewed this inventive device. In fact, the FDA's decision was so controversial that even President Obama had to weigh in with his signature on the final rule.
The FDA and Medicare apparently contrived to slow the adoption of a pioneering replacement heart valve, fearing too many seniors on Medicare would seek out the procedure, according to this WSJ report. The innovative medical device acts as an artificial replacement for the body's own aortic valve that is situated between the left ventricle and aorta within the human heart. This valve controls the flow of blood away from the heart; however, it starts to narrow as part of the ageing process, reducing the flow and thus leading to heart failure, and it some cases, death. Although open-heart surgery is typically the only other treatment option - an operation not without it's risks and associated costs, bureaucrats apparently eschewed this inventive device. In fact, the FDA's decision was so controversial that even President Obama had to weigh in with his signature on the final rule.