FDA Nod for Thoratec Controller


Thoratec Corp. (THOR), a leader in mechanical circulation support devices, recently revealed that it has received approval from the Food and Drug Administration (:FDA) to sell the HeartMate II Pocket Controller meant for use with the HeartMate II LVAD System. 

The Pocket Controller is smaller than earlier versions of left ventricular assist device (:LVAD) system controllers. It comes with a friendly interface for the user. The controller fits into the front pocket and is intended to facilitate the busy routine of patients using HeartMate II LVADs. 

Thoratec will start providing training at domestic centers for the Pocket Controller in the week of May 20, 2013. Subsequently, the Pocket Controller may be procured by patients.   

Thoratec enjoys a first-mover advantage in the market it serves. With HeartMate II, Thoratec enjoys a monopoly in the U.S. market since it has developed the only device of its kind for the destination therapy indication (for heart failure patients who are not eligible for heart transplant).

However, its dominance in the bridge-to-transplant (BTT) indication has ended following the FDA approval of HeartWare International’s (HTWR) Ventricular Assist System in Nov 2012. Competition with HeartWare has led to loss of market share and revenue shortfall for Thoratec.

Despite limited visibility and periodic setbacks, Thoratec has successfully expanded its sales on the back of its HeartMate II product line. The company continues to do well in overseas markets although the base is small. It received reimbursement approval in Japan on Apr 1, 2013, which enables it to commercialize the HeartMate II as a BTT for victims of advanced heart failure. Thoratec commercialized the Pocket Controller in Europe in Mar 2013.

The stock carries a Zacks Rank #4 (Sell). We are more optimistic about Becton, Dickinson and Company (BDX) which carries a Zacks Rank #2 (Buy) and is expected to do well. In addition, Conceptus, Inc. (CPTS) carries a Zacks Rank #1 (Strong Buy) and warrants a look.

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