Thoratec Corp. announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the HeartMate II(R) Pocket Controller(TM), the small, smart, safe face of the HeartMate II LVAD System. The Pocket Controller is designed to support the active lifestyles that patients with HeartMate II LVADs are leading. The Pocket Controller is lighter and more compact than previous LVAD system controllers, and it features an intuitive user interface with enhanced information content. Additionally, with a single-side cable design, the device can slide easily and discreetly into a front pocket. The Pocket Controller has also been designed to promote patient safety, through features including prioritized visual alarms, on-screen instructions, and a backup battery, which can provide at least 15 minutes of full power during periods of inadvertent disconnections from power sources. Thoratec will begin training U.S. implanting centers on the Pocket Controller during the week of May 20th. Following clinician training, the Pocket Controller will be available for new patients as well as for current HeartMate II patients eligible to upgrade their existing system controllers. Patients should contact their centers to learn more about the HeartMate II system and the new Pocket Controller.

Thoratec Corp. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. The company reported revenues of $117.7 million, a 7% decrease versus revenues of $126.8 million in the same period a year ago. Net income on a GAAP basis was $18.2 million, or $0.31 per diluted share, compared to GAAP net income of $25.5 million, or $0.43 per diluted share, in the same period last year. Non-GAAP net income was $24.0 million or $0.41 per diluted share in the first quarter of 2013, compared to non-GAAP net income of $30.6 million, or $0.51 per diluted share, in the first quarter of 2012. For the quarter, the company reported income from operations of $23.4 million against $37 million a year ago. Income before income taxes was $24.5 million against $37 million a year ago. The company reaffirmed existing guidance for the full year for revenues as well as net income per diluted share on both a GAAP and non-GAAP basis. Revenues are expected to be in the range of $490 million to $510 million. GAAP net income per diluted share is expected to be in the range of $1.32 to $1.42, and non-GAAP net income per diluted share is expected to be in the range of $1.76 to $1.86.

Thoratec Corp., Q1 2013 Earnings Call, May 02, 2013