A heart failure implantable device called CardioMEMS was rejected by six out of ten members of a Food and Drug Administration advisory committee, who claimed they could not determine whether the device’s benefits outweighed its risks.
This vote will help the FDA consider whether or not the device should be approved for use in the marketplace. If the verdict had gone in favor of CardioMEMS, it could have paved the way for St. Jude Medical to buy the rest of the company for $375 million. Last year, the heart device maker bought its share of CardioMEMS for $60 million, and could now buy the rest.
While the FDA panel found the device to be safe for patients suffering from moderate heart failure, its effectiveness was called into question by an FDA staff report which claimed that the company intervened in clinical research to a degree that exceeded the study’s protocol.
In a study of 550 heart failure patients, it was found that using CardioMEMS led to a significant reduction in hospital visits compared to standard heart failure treatment. But the panel could not determine whether the benefits were due to the device or the medical attention given by the nurses in the study, who were employed by the company.
If the FDA officially approves CardioMEMS, it would be the first implantable heart failure diagnostic sy
