The Food and Drug Administration, USA, has approved the use of SAPIEN 3 THV (Transcatheter Heart Valve) for patients with the issue of narrowing heart aortic valve, known as aortic valve stenosis. Aortic valve stenosis hinders the flow of blood from heart into aorta that results in serious heart issues. The SAPIEN 3 THV has now been approved to used for the patients suffering from the problem of aortic valve stenosis who are almost at high risk or inoperable for death or intricacy pertained to open-heart surgery.
The SAPIEN 3 THV is the 3rd generation of the earlier SAPIEN THV that was approved by FDA originally in 2011. This device has got a major uplift in design by including a skirt at the bottom of the valve to reduce leakage around valve.
Calcium deposits develop on the aortic valve when a person ages. These deposits of calcium may never result in any problem, but, in some patients, they contribute a part in causing aortic valve stenosis. Since the aortic valve turns narrow, it becomes harder for heart to work in pumping enough blood via the smaller opening and consequently heart may get weakened. Aortic valve stenosis can result fainting, heart failure, chest pain, cardiac arrest or irregular heart rhythms. Patients having severe aortic valve stenosis typically required having a replacement of heart valve to enhance blood flow through the aortic valve.
It has been shown by clinical data that SAPIEN 3 THV is superior to the 1st generation SAPIEN, with significantly reduced leakage around and through the valve, told the acting director of Office of device evaluation, William Maisel.
The SAPIEN 3 THV can assist correcting the problem of blood flow dealing with aortic stenosis in the patients who necessitate open-heart surgery for replacing the problematic valve, however to whom the surgical procedure is believed to be too risky. Due to the overall risks as well as the extended recovery period pertained to the open-heart surgery, around thirty percentages of the patients are regarded at high risk or inoperable for the surgical complications and also not considered for the open-heart surgery.
In the clinical studies, the SAPIEN 3 THV established a reasonable assurance of effectiveness and safety for those patients with no need of open-heart surgery. However, patients who get SAPIEN 3 THV are also facing serious complications from implantation process, like stroke, death, heart attack, bleeding, acute kidney injury and the call for a permanent peacemaker.