MitraClip Rejection is Temporary Setback among Cardiac Advances
This week the Food and Drug Administration did not approve a device called MitraClip, a minimally-invasive system for treating mitral valve insufficiency. The condition, also known as mitral regurgitation, causes regurgitation of blood back into the left atrium from the improper functioning of the mitral valve and is one of the most common valvular heart diseases in the elderly. The rejection marks a setback in a field that has seen significant progress in recent years, as complicated cardiac devices and transplants become more and more common.
The FDA cited insufficient evidence on the safety and effectiveness of MitraClip to approve its use for the general population, although it has already been used on about 8,000 patients as an “investigational device.” It is meant for high-risk or inoperable patients and is inserted through a catheter into the blood stream. Abbott Laboratories, the maker of the device, is in the process of gathering more data and hopes to attain approval once more trials are done.
Despite the MitraClip rejection, the fields of heart devices and surgery have seen important advances over the past decades. The first successful heart transplant was performed in 1967 by Christiaan Barnard, and the procedure gained traction in the 1980s. In 1986, French surgeons Alain Carpentier and Gilles Dreyfus performed the first artificial heart implant in Europe. Dreyfus has also invented new techniques in valve repair surgery, including the introduction of the use of a stentless and reproducible autologous pericardium.
Heart surgery has continued to become less invasive, with the first minimally-invasive aortic heart valve surgery being performed in 1996. Even the most dramatic of procedures, a heart transplant, has moved from being totally experimental to well-documented. In the U.S., there are now around 2,000 heart transplants a year.
So while the MitraClip rejection is a temporary setback, we can expect to see heart surgeries and transplants to become more and more common and less and less invasive. Heart disease remains a formidable foe - it is the leading cause of death in the US and many other Western countries – but we are slowly moving toward a world in which a new heart, whether real or artificial, may become a routine procedure.
Tags: Heart , Health , Surgery , Cardiac , Mitraclip , Fda , Medical Devices , Mitral Valve , Cardiac Surgery
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