WASHINGTON, DC – A news article posted on medtechdive.com reports that Abbott Laboratories has halted enrollment in the company’s HeartMate PHP catheter blood pump trial. According to a government clinical trial tracking agency, the medical device is used during high-risk percutaneous coronary interventions (PCI). The trial’s enrollment was shut down after there was a report stating the device’s impeller speed began to drop at the end of the surgical procedure.
Abbott’s HeartMate PHP catheter comprises a small propeller inside of a thin wire cage. The device is inserted into a patient’s heart to keep the flow of blood moving at a predictable rate while an unblocking of clogged vessels procedure is being performed. The trial, called SHIELD II, was a study to measure the HeartMate PHP catheter’s performance versus Abiomed’s Impella blood pumps. Abiomed’s Impella blood pumps have already been approved for high-risk percutaneous coronary interventions (PCI).
Abbott’s HeartMate PHP catheter has had severe setbacks throughout the past few years. In 2019, Abbott pushed back the SHIELD II study’s end date to December 2021. In 2018, Abbott Laboratories recalled their HeartMate 3 LVAD due to blood clotting or death risks. Abbott distributed multiple warning notices to medical professionals about the risks. The US Food and Drug Administration labeled the recall a Class I event. The most severe FDA recall classification.
The HeartMate 3 LVAD was already recalled in Europe after eight reports of motor stoppage. The issue is blamed for causing one death, according to a 2017 announcement from Abbott to Germany’s Federal Institute for Drugs and Medical Devices.
Abbott Laboratories halted the medical device’s use in the US and Europe in 2017 because of reports detailing several device malfunctions. At this time, the HeartMate PHP was approved in Europe and was in clinical trials in the United States.
According to Abbott Laboratories, the malfunctions only affect around 1.9% of medical devices shipped.
The SHIELD II trial was initiated back in August 2015, and the study enrolled over 715 patients before the study was suspended by December.
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