UPDATED Feb. 9, 2017, with details on Abbott’s letter to physicians.
Abiomed (NSDQ:ABMD) shares closed up more than 5% yesterday as investors reacted to reports that Abbott (NYSE:ABT) paused its HeartMate PHP program in Europe.
Abbott, which acquired the Thoratec line of HeartMate cardiac assist devices when it paid $25 billion for St. Jude Medical (NYSE:STJ) last month, advised physicians Feb. 6 that it’s temporarily halting its Shield II clinical trial for the HeartMate PHP pump due to an issue with its catheter.
Abbott said it “temporarily paused the HeartMate PHP Shield II IDE clinical trial as well as shipment and implantation of the device for commercial, clinical and investigative use in Europe while conducting a Field Safety Corrective Action for the HeartMate PHP catheter” in a Feb 6 letter to physicians.
“This step is being taken as a precaution due to reports of a small number of clinical events associated with pump stoppage during support of high-risk percutaneous coronary intervention (PCI) patients in both clinical and commercial uses. To date, Abbott has received reports of eight (8) motor stoppage events worldwide, representing 1.9% of devices shipped. Of the eight (8) devices, one (1) stoppage caused hemodynamic instability requiring emergency intervention and one (1) resulted in death associated with sepsis several days after the intervention. The remaining pump stoppage reports were not associated with an adverse event,” Abbott wrote.
Abbott did not specify when the HeartMate PHP program might resume, saying only that it’s investigating the issue and will re-start once corrective actions are in place.
The delay extends the lead for Abiomed and its competing line of Impella pumps, prompting investors to push ABMD shares up 5.3% to a $110.50-per-share close yesterday.
“As the only real percutaneous temporary support device on the market today, ABMD seems well-positioned to retain its monopoly for at least the next year or two now, in our view, if not longer,” Leerink Parters analyst Danielle Antalffy wrote in a note to investors.
ABT shares closed down -0.8% to $42.43 apiece yesterday and slid a further -1.6% to $41.76 per share in pre-market trading today.
