), a leader in mechanical circulatory assistance devices,
recently revealed that it was granted approval by the Japanese
Ministry of Health, Labour and Welfare to commercialize HeartMate
II for bridge to transplantation purposes for victims of advanced
Thoratec and its distributor partner Nipro Corporation
forecast commercialization of HeartMate II in Japan around the
latter part of the first quarter of 2013. Prior to the launch,
the reimbursement mechanism will be set up and the participating
centers trained. Around 15 hospitals will participate in the
launch including the earlier trial locations and other
institutions certified to carry out ventricular assist devices
Thoratec will provide training in surgical procedures besides
extending help to Nipro. For its part, Nipro will provide
qualified staff to ensure clinical, marketing and sales backup
for the commercialization of HeartMate II.
Ventricular Assist Devices represent a multi-billion dollar
market opportunity. It is estimated that, in addition to the
bridge-to-transplant (BTT) market, the Destination Therapy (DT)
market in the U.S. may eventually attain a significant size.
Until HeartMate II came up as a viable option, the only treatment
was heart transplant surgery.
HeartWare International Inc.
), a global provider of miniaturized ventricular assist devices
(VAD) for diagnosis of advanced heart failure, disclosed on
November 20, 2012, that the U.S. Food and Drug Administration
(FDA) has granted clearance for its HeartWare Ventricular Assist
System as a bridge to heart transplantation device for patients
with end-stage heart failure. The FDA approval has been eagerly
awaited ever since HeartWare submitted its Premarket Approval
(PMA) application in December 2010. The company obtained European
CE Mark for the HeartWare system in 2009 and Australian
Therapeutic Goods Administration (TGA) approval in 2011.
However, there is no imminent competitive threat from
HeartWare in the DT segment, as the product is not expected to be
launched possibly till 2015. We believe that DT will account for
the major part of growth in the Ventricular Assist Device (VAD)
Despite less visibility, Thoratec has expertise in product
development. The company is currently developing its next
generation HeartMate III. At the same time, HeartWare is expected
to close the technological gap. The company continues to do well
in overseas markets despite economic turmoil in Europe.
Our Outperform recommendation is supported by a short-term
Zacks #1 Rank (Strong Buy).
HEARTWARE INTL (HTWR): Free Stock Analysis
THORATEC CORP (THOR): Free Stock Analysis
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