FDA Nod for Thoratec Controller - Analyst Blog
20 Mayo 2013 - 2:40PM
Zacks
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.
BECTON DICKINSO (BDX): Free Stock Analysis Report
CONCEPTUS INC (CPTS): Free Stock Analysis Report
HEARTWARE INTL (HTWR): Free Stock Analysis Report
THORATEC CORP (THOR): Free Stock Analysis Report
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