
Rival heart pump makers Abiomed (NSDQ:ABMD) and Thoratec (NSDQ:THOR) got caught in the halo effect surrounding HeartWare International‘s (NSDQ:HTWR) Wall Street-stirring regulatory win.
ABMD shares rose 3.7% to $24.49 and THOR gained 3.2% to $34.76 as of about 3:20 p.m. today, following news that an FDA advisory panel recommended approval for HeartWare’s HVAD implantable heart pump as a so-called "bridge to transplant" for people with end-stage heart failure.
The news sent HTWR shares up 12.1% to $77.65 in afternoon trading today, following a 1-day blackout.
The NASDAQ stock exchange yesterday halted trading of HTWR shares pending the outcome of the panel, after FDA documents released ahead of the hearing prompted analysts to predict the positive vote.
Earlier this month analysts predicted that Thoratec and HeartWare would carve out a 50-50 split on the market for left ventricular assist devices, citing opinions from "a high-volume EU cardiothoracic surgeon" from "1 of the largest LVAD implanting centers worldwide."
Thoratec’s HeartMate II heart pump, which already has bridge-to-transplant approval, recently underwent a Class I recall over concerns that an improperly connected component may result in deformation or tearing of the device’s outflow conduit.
Abiomed’s Impella pump, which won FDA clearance in June 2008, makes up the bulk of its sales. The company credited the workhorse device with leading it to the best year in its history, posting 2011 sales of $101 million, an 18% spike from the previous year.
The device maker unveiled a catheter-based Impella cVAD device late last year, and won CE Mark approval in the European Union earlier this month.