Thoratec Corp. revealed that it has kicked off its CE Mark clinical trial for HeartMate III with the first human implant at Hannover Medical School in Hannover, Germany. Shares of the company rose 1.4% following the announcement of the clinical trial.
HeartMate III is the next-generation continuous flow left ventricular assist device (LVAD). It is based on fully magnetically levitated technology in order to reduce adverse event rates through improved hemocompatibility with a compact size that enhances ease of surgical placement. HeartMate III is designed for low-power operation.
THOR's previous generation HeartMate II is the rotor driven continuous flow intermediate-to-chronic LVAD. HeartMate II has been approved for use in North America and EU.
THOR's HeartMate III CE Mark clinical trial will admit up to 50 patients at nine sites in Europe, Australia, and Canada. The trial includes a primary endpoint of six-month survival compared with estimated mortality based on the Seattle Heart Failure Model.
Apart from first implant in Germany, enrollment of the HeartMate III CE Mark Trial has also started at the Vienna Medical University in Vienna, Austria.
THOR continues to do well in overseas markets, especially in its HeartMate lineup. Despite being flat year-over-year, THOR’s 2014-first quarter earnings and revenues surpassed the Zacks Consensus Estimates on both earnings and revenue fronts.
THOR posted flat adjusted earnings of 33 cents per share for the 2014-first quarter compared with the year-ago level but beat the Zacks Consensus Estimate by 6 cents. Adjusted earnings edged down 1.8% to $19.2 million from $19.5 million in the comparable quarter a year ago.
THOR’s revenues in the quarter rose 6.8% to $125.7 million, exceeding the Zacks Consensus Estimate of $124.0 million. Revenues from the U.S. upped 3.6% to $95.6 million while the same from international business grew 18.5% to $30.1 million.
Revenues from the flagship HeartMate product line came in at $110.0 million, reflecting a 6.9% year-over-year increase due to the expansion of its international business.
For fiscal 2014, THOR expects revenues in the range of $520–$535 million. The current Zacks Consensus Estimate of $527 million lies within the guided range.
THOR also expects adjusted earnings per share (excluding stock based compensation) of $1.39–$1.49 for the year. The current Zacks Consensus Estimate of $1.31 lies below the guided range.
Currently, THOR retains a Zacks Rank #3 (Hold). Some better-ranked medical instrument companies that are worth considering at the moment include Alphatec Holdings, Inc. (ATEC - Free Report) , Luminex Corp. (LMNX - Free Report) , and Accuray Inc. (ARAY - Free Report) . Alphatec and Luminex sport a Zacks Rank #1 (Strong Buy), while Accuray carries a Zacks Rank #2 (Buy).