The U.S. Food and Drug Administration (FDA) recently announced the recall of all Boston Scientific LOTUS Edge Aortic Valve Systems. These systems are comprised of two separate parts, one being the valve and the other the delivery system. These devices are used to treat patients with aortic stenosis who are at high risk of open-heart surgery.
Though the valve itself seems to work well once it’s successfully implanted, Boston Scientific has had numerous problems with the delivery system used to place the valve inside a patient’s body and the LOTUS product line has been marred with recalls in recent years.
How Doctors Used the LOTUS Edge Aortic Valve System
The aortic valve helps control how much blood flows through the heart. Patients with aortic stenosis have an aortic valve that has narrowed, which either reduces or completely blocks the necessary blood flow. Consequently, the valve pushes the heart to work harder to pump blood, and over time, can increase the risk of heart failure, blood clots, stroke, and heart attack.
Doctors may treat moderate to severe cases of aortic stenosis by replacing the affected valve during open-heart surgery. Some patients, however, suffer from more severe health complications rendering open-heart surgery too risky. The FDA approved the Boston Scientific LOTUS Edge Aortic Valve System for use in these patients.
Instead of opening the chest to repair the valve in the heart, doctors have the option of using a minimally invasive procedure called a “transcatheter aortic valve replacement (TAVR).” During this procedure, the doctor inserts a catheter in the leg or chest and guides it to the heart. He then inserts a replacement valve through the catheter to the heart, places it in the correct spot, and removes the catheter.
The Boston Scientific device was one of several on the market today for use in TAVRs. It was different than the others in that it allowed doctors to remove, retrieve, and reposition the valve as needed. Initial trials on the device showed that it was effective and performed well in patients, but the company has had continued problems with the delivery system.
Repeated Issues Reported with LOTUS Edge System
Boston Scientific noted in a press release that while it’s been pleased with the benefits the LOTUS Edge has provided patients, “we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve.”
The company released the device on the European market back in 2016, long before it received FDA approval to sell it in the U.S. Yet shortly after its European release, the device was linked with reports of breakage. The breaks resulted in three deaths from catastrophic vessel trauma. The company issued a voluntary recall and by March, had replaced the dysfunctional release component.
In October of that same year, however, the company again received reports of problems with the device, this time associated with the delivery system locking mechanism. In January 2017, the company announced it had fixed that problem, but then it heard about more issues soon after. In November 2020, Boston Scientific announced it was recalling all of the products globally because of ongoing challenges with the delivery system. The FDA announced the recall a couple of months later.
On the U.S. market for about a year and a half, the LOTUS Edge system was never without problems, yet the manufacturer failed to provide adequate warnings to doctors and patients about the issues. It has now stated that it will focus on Its other aortic valve products, including the ACCURATE neo2 Aortic Valve System.
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