Abbott Laboratories, which acquired Minnesota medical device maker St. Jude Medical last month, is halting use of a commercially promising blood pump in the U.S. and Europe following a patient death and several malfunctions.
The device at issue, 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 blood vessels.
Touted as a key growth driver by St. Jude and most recently by Abbott, the device is approved for commercial sales in Europe, and was in advanced clinical testing in the U.S., including at two hospitals in Minnesota.
In a Feb. 6 recall notice, published Thursday by the Federal Institute for Drugs and Medical Devices in Germany, Abbott said it has received eight reports of pumps stopping during high-risk procedures to unblock blood vessels.
One malfunction caused irregular blood flow that required an emergency intervention to save the patient, while another case resulted in a "death associated with sepsis several days after the intervention," Abbott's letter to doctors says. The other pump stoppages were not linked to adverse events, the company said.
Abbott said the eight problems affected 1.9 percent of the devices shipped, implying about 420 units in the market are affected by the Feb. 6 recall notice.
"Abbott is temporarily pausing the use of HeartMate PHP devices to allow the company time to evaluate and implement corrective actions," the letter said. "In the interim, do not use units within your possession. ... Hospitals will be required to return all HeartMate PHP catheter inventory to Abbott."
In the U.S., Abbott temporarily suspended enrollment in a 425-patient study comparing the HeartMate PHP to similar heart-pump devices made by Massachusetts' Abiomed. An Abbott spokesman confirmed Thursday that the suspension of the U.S. trial was related to the same issue identified in the Feb. 6 letter to doctors.
"The pause in our U.S. study and commercial implants [in Europe] ... are being taken as a precaution due to reports of a low number of clinical events associated with pump stoppage," spokesman Justin Paquette wrote in response to e-mailed questions.
Clinicaltrials.gov, which is maintained by the U.S. National Institutes of Health, says the study's 64 sites around the United States include the University of Minnesota Medical Center Fairview in Minneapolis and the Mayo Clinic in Rochester. It's not clear when Abbott will restart the study, which is called Shield II.
The HeartMate PHP is used inside the heart without needing open-chest surgery.
Its thin impeller and the nitinol wire-mesh that surrounds it are folded inside a delivery catheter that is less than 5 millimeters wide when inserted into the femoral artery and advanced into the heart. The fully removable device is designed to be used for up to six hours to maintain regular blood flow in a high-risk patient while a doctor performs another procedure to unblock a severely calcified artery.
The device was developed by California-based Thoratec, which St. Jude Medical acquired in a $3.3 billion deal in late 2015. Abbott acquired St. Jude just over a year later.
St. Jude touted its play for Thoratec as way for the company to build the med-tech industry's broadest portfolio of heart-failure devices, from St. Jude's CardioMEMS monitor and implantable resynchronization defibrillators to Thoratec's high-ticket left-ventricle assist devices, or LVADs.
After buying Thoratec, then-St. Jude CEO Dan Starks highlighted the commercial potential of the HeartMate PHP, or Percutaneous Heart Pump, with investors in an earnings call:
"We think the growth available at St. Jude Medical in the area of Percutaneous Heart Pumps is higher than some investors may realize," Starks said in October 2015. Although developing the product for market would "take time," Starks said, PHP devices would become "another significant new growth driver over the next five years."
The device was later touted in Abbott handouts as a promising part of the combined company's future pipeline, alongside Abbott's most advanced FDA-approved coronary stents, the Absorb and Xience systems.