Edwards Lifesciences has warned the doctors about the low risk of burst balloons during its Sapien 3 Ultra replacement heart valve’s implantation. Physicians are also cautioned to closely follow the instructions for use to avoid the problem.
The Irvine, California-based company won CE-Mark in the European Union in November 2018 for the latest iteration of its transcatheter aortic valve replacement. Its approval from the FDA followed in December.
The company said that they have received many reports of burst balloons with the Sapien 3 ultra and this had made the withdrawal of the system from the patient very difficult. The complaint rate is around 1.0% “based on the limited experience with the device” and about 0.5% of them have caused clinical implications for the patient including difficulty in removal of valve’s delivery system, vascular injury.
Two factors influencing balloon bursts, excess inflation volume and fast inflation conditions were observed in the investigation and these are addressed in the Sapien 3 Ultra instructions for use.
Additional warning will also be added to the device’s instructions for use, to avoid failures in slow inflation to prescribed volumes and balloon rupture.
Mr Vinod Arora, Principal Advisor, IGMPI
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