Boston Scientific has pulled global sales of, and is no longer seeking FDA approval for, its Acurate neo2 and Acurate Prime aortic valve systems.
In a May 28 Securities and Exchange Commission filing, the technology company said the “additional resources and investments” required to meet regulatory approval on the systems would be financially “prohibitive.”
During a recent investigational study, more than one in five of the valve systems failed to fully expand after implantation. Patients with underexpanded valves “fared significantly worse” than patients with fully expanded valves, according to a May 28 report from TCTMD.
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