* Agency says life-saving benefits outweigh risks such as
stroke
* Shares rally 9.2 percent on Nasdaq
By Susan Kelly
Nov 20 (Reuters) – The U.S. Food and Drug Administration
said it has approved a heart pump made by HeartWare
International Inc’s that supports blood flow in people
with failing hearts who are awaiting a transplant.
The company’s shares rose 9.2 percent.
HeartWare’s left ventricular assist device, or LVAD, is
designed to be implanted in the chest near the heart and used
inside or outside the hospital.
The device will compete with Thoratec Corp’s
HeartMate II, which has been sold in the United States since
2008 and had been the only heat pump available to heart failure
patients awaiting a transplant.
Some investors have bet that HeartWare’s device will eclipse
the HeartMate II because it is smaller and takes less time to
implant. However, concerns about pump-associated thrombosis, or
the formation of blood clots, as well as stroke, could hurt the
HeartWare device’s market share.
HeartWare’s shares have slumped about 15 percent in the past
six weeks as investors grew nervous about whether the product
would be approved.
The FDA said the life-saving benefits of the device in the
intended population of patients with end-stage heart failure
outweighed risks observed during the clinical trial, such as
infection and stroke.
J.P. Morgan analyst Michael Weinstein said the approval
could propel revenue growth of at least 30 percent a year for
HeartWare, with half of the expected volume generated by market
share taken from Thoratec.
He expects HeartWare’s shares to recoup much of their recent
losses with the U.S. approval. The device is already sold in
Europe.
The device was approved based on data from a study of 137
patients with advanced heart failure who received the HeartWare
LVAD. The data was compared with outcomes from patients followed
by a medical database who used other mechanically assisted
circulatory support systems.
It was the first time the FDA has approved an LVAD using
information from a database as a comparison, the agency said.
Heart failure is considered end stage when the underlying
condition no longer responds to medical therapy or other
treatment options. LVADs can be used as a bridge therapy for
patients until a donor heart becomes available.
An estimated 50,000 people around the world are candidates
for a heart transplant, but only about 5,000 get one each year.
Shares of HeartWare, based in Framingham, Massachusetts,
climbed $7.53, or 9.18 percent, to end at $89.54 on Tuesday on
the Nasdaq. Shares of Thoratec, based in Pleasanton, California,
fell 39 cents, or 1.1 percent, to close at $35.
