Sales of its implantable heart pump surged during the 4th quarter and 2012 for HeartWare International (NSDQ:HTWR) after the medical device company won FDA approval for its flagship left ventricular assist device late last year.

Framingham, Mass.-based HeartWare reported losses of $21.1 million, or $1.46 per share, on sales of $32.7 million for the 3 months ended Dec. 31, 2012, for top-line growth of 41.6% and a 2.1% paring of net losses.

For the full year, HeartWare posted losses of $87.7 million, or $6.15 per share, on sales of $110.9 million, for sales growth of 34.0%.

HTWR shares came out of the gate strongly today on the news, gaining 4.6% to peak at $91.08 each before subsiding to $86.48 as of about 9:50 a.m.

"Our results for the 4th quarter reflect positive initial trends in the commercial launch of the HeartWare ventricular assist system in the U.S., following approval from the Food and Drug Administration on November 20, 2012, and continued strong support from our international customers," president & CEO Doug Godshall said in prepared remarks. "With 345 HVAD pumps sold during the 4th quarter, the largest number in any quarter to date, the total number of pumps sold in 2012 was 1,217, compared to 932 pumps sold in 2011. Our team has been working diligently to expedite the training of additional hospitals in the U.S., and since FDA approval 18 new U.S. sites have been trained, with 2 more in training this week."

The FDA granted pre-market approval for bridge-to-transplant patients for the LVAD last year.