What's Happening?
Boston Scientific has revised the instructions for its Watchman heart device after reports of 120 serious injuries and 17 deaths. The FDA issued an early alert regarding the update, highlighting the risk of air bubbles entering the vascular system during the implantation procedure if the patient's breathing is not controlled. The risk is particularly high for patients under sedation, as opposed to general anesthesia, which provides ventilatory support. The update advises physicians to manage risks by ensuring patients are not hypovolemic and by keeping the access valve below the heart during device exchange.
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Why It's Important?
The update is crucial for patient safety during heart device implantation procedures. The Watchman device is widely used, with sales increasing by 28% in the second quarter, particularly in the U.S. The revised instructions aim to mitigate risks associated with the procedure, potentially preventing further injuries or fatalities. This development underscores the importance of stringent safety protocols in medical device usage, impacting healthcare providers and patients relying on these devices.
What's Next?
Boston Scientific plans to expand its Watchman device sales globally, following its success in the U.S. Healthcare providers may need to adjust their procedural protocols in line with the updated instructions to ensure patient safety. The FDA and Boston Scientific will likely continue monitoring the situation to assess the effectiveness of the new guidelines and make further adjustments if necessary.
