The Watchman heart device by the Boston Scientific Corp received a mixed review from the U.S. Food and Drug Administration (FDA) on Wednesday.
An advisory panel to the federal body conducted a clinical trial and found the device safe, though not particularly, effective in lowering the stroke risk in a certain type of irregular heart beat patients.
Despite the heart device falls short in treating crucial heart condition, it managed to get 6-5 votes of the panel, with one abstention.
According to the advisory panel, the benefits of the device outweigh the risks, with some panelists asserting it as an alternative for heart patients.
Meanwhile, the Boston Scientific is seeking green signal from the FDA for its device to treat serious health conditions including reducing stroke risk and blood clots in patients diagnosed with non-valvular atrial fibrillation. In the absence of such device, these patients are typically administered with an oral treatment, warfarin, which has some limitations.
Atrial fibrillation is a health condition in which heart starts beating abnormally, leading to stroke.
This is not the first time when the FDA’s advisory panel has met to discuss the product. Earlier in December 2013, the FDA panel voted in favor of its safety and efficacy. But a follow-up medical trial data brought glaring exposure before the panel that showed an additional risk of ischemic stroke in patients treated with the Watchman.
It’s not required for the federal body to follow the recommendations proposed by the advisory panel. Earlier, the FDA has ignored two panel’s suggestions in favor of approving the Watchman. As the FDA typically considers panel recommendations, the device maker is eagerly awaiting the go ahead from the federal health body.