Thoratec Warns About HeartMate Controller - Analyst Blog
March 06 2014 - 3:00PM
Zacks
Thoratec Corporation (THOR) sent safety
advisory to hospitals regarding the use of its pocket system
controller for mini heart pump device, HeartMate II. The
Pleasanton, Calif.-based company received reports of four deaths
and five patient injuries that happened while switching from
primary system controllers to backup system controllers.
Investors reacted negatively to the news, resulting in a 2.7% fall
in THOR shares to $36.22 after the market closed yesterday.
Meanwhile, shares of the rival heart pump maker, HeartWare
International, Inc. (HTWR) rose 0.1%.
HeartMate II left ventricular assist device (LVAD) is implanted in
patients with advanced heart failureto help the heart pump blood.
It is connected to an external battery pack and a system
controller, which alarms patients if the battery runs down.
THOR started selling the new system controller for the device in
Aug 2012 in Europe and in May 2013 in the U.S. It has been
prescribed to 2,142 patients since Aug 2012.
THOR revealed that four patients died while struggling to change
their controller themselves while five others lost consciousness or
suffered decreased blood flow due to difficulty in switching
controllers.
However, THOR claimed that the deaths and injuries occurred not due
to problems or defects in controllers but due to lack of training.
Therefore, it didn’t recall the devices. The company stated that
the affected patients may not have received proper training with
the new controller and failed to understand its difference from the
old controller model.
As a result, THOR advised that all the patients using the new
controller and their caregivers should be retrained from using the
new controller as they are at a higher risk of experiencing
difficulties in the switching process.
THOR posted adjusted earnings of $17.5 million or 30 cents per
share for the fourth quarter of 2013, which declined 9.3% from
$19.3 million or 6.25% from 32 cents per share in the comparable
quarter a year ago. Earnings per share were in line with the Zacks
Consensus Estimate.
THOR’s revenues in the quarter dipped marginally by 0.2% to $128.2
million, lagging the Zacks Consensus Estimate of $130.0 million.
Revenues from HeartMate product line came in at $111.7 million,
reflecting a 5.2% 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 $528 million lies
within the guided range. The company also expects adjusted earnings
per share of $1.40–$1.50 for the year. The current Zacks Consensus
Estimate of $1.28 million lies below the guided range.
Currently, THOR retains a Zacks Rank #3 (Hold). Some better-ranked
stocks in the medical instruments sector include Natus
Medical Inc. (BABY) and Cynosure, Inc.
(CYNO). Both of them carry a Zacks Rank #1 (Strong Buy).
NATUS MEDICAL (BABY): Free Stock Analysis Report
CYNOSURE INC-A (CYNO): Free Stock Analysis Report
HEARTWARE INTL (HTWR): Free Stock Analysis Report
THORATEC CORP (THOR): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
Heartware International, Inc. (MM) (NASDAQ:HTWR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Heartware International, Inc. (MM) (NASDAQ:HTWR)
Historical Stock Chart
From Apr 2023 to Apr 2024