Abbott Laboratories has suspended enrollment in its trial of the HeartMate PHP catheter blood pump for use during high-risk percutaneous coronary interventions (PCI), according to a government tracker of clinical trials.
Trial enrollment was halted after a report of reduced impeller speed at the end of a procedure. The HeartMate PHP catheter consists of a propeller inside a thin wire cage that is inserted in the heart to keep blood flowing at a predictable rate during a procedure to unblock clogged vessels. The trial, called SHIELD II, was a head-to-head study with any of Abiomed’s Impella blood pumps approved for high-risk PCI.
- In 2019, Abbott pushed back the end date for the SHIELD II study to December 2021. Abiomed investors seemed to respond favorably at the time, sending the company’s stock price up by nearly 5% after the delay was announced, according to Seeking Alpha. However, there was no meaningful stock movement following Tuesday’s update regarding the suspended enrollment.
Abbott's HeartMate technology was the result of its $25 billion acquisition of St. Jude Medical in 2017. St. Jude acquired the device's developer Thoratec in a $3.4 billion deal in 2015.
A separate product, HeartMate 3 left ventricle assist device (LVAD), has gained multiple approvals for use in patients. FDA granted premarket approval of the device for patients awaiting transplant in 2017. The agency then approved the HeartMate 3 as a permanent implant for people who have heart failure and are ineligible for transplant in 2019. And, in February 2020, the FDA approved a less invasive surgery for implant of the device.
However, the technology has had setbacks over the years.
In 2018, Abbott recalled the HeartMate 3 LVAD due to the risk of blood clotting or death following multiple warning notices put out to medical professionals. The FDA labeled the recall a Class I event.
Along with the trial delay — and now enrollment suspension — HeartMate PHP has had its own set of problems.
Abbott stopped use of the device in the U.S. and Europe in 2017 due to multiple malfunctions. At the time of the decision, HeartMate PHP was approved in Europe and in clinical trials in the U.S.
The device was recalled in Europe due to eight reports of motor stoppage, which resulted in one serious intervention and one death, according to a 2017 notice from Abbott to Germany’s Federal Institute for Drugs and Medical Devices.
Abbott said that the malfunctions impacted 1.9% of devices shipped.
The SHIELD II trial began in August 2015 and enrolled an estimate of 716 patients at the time of its suspension. It was scheduled to be completed by December.
This story has been updated to clarify the relationship between HeartMate products.