By Dow Jones Business News, March 10, 2013, 03:22:00 PM EDT
--Edwards Lifesciences' new Sapien XT device meets primary study goal
--Device is at least as effective as older device already approved in the U.S.
--New device is smaller and thinner than the original
(Includes additional details throughout.)
By Joseph Walker
Edwards Lifesciences ( EW ) said a new version of its nonsurgical heart valve met its primary study goal in a late-stage
trial, and that it would seek U.S. regulatory approval later this year.
If the device is approved, it could help Edwards extend its lead in the burgeoning market for replacement heart valves
that can be implanted without open-heart surgery.
Its Sapien heart valve is the only such product approved in the U.S., helping to grow profits 44% in the fourth
quarter, but rival Medtronic Inc. ( MDT ) has a competing product that it hopes to bring to the U.S. market next year.
The U.S. Food and Drug Administration is expected to make a decision on Edwards's new device by the second quarter of
"This device is basically a better, easier device to use" than the Sapien, said Gary Mintz, chief medical officer of
the Cardiovascular Research Foundation.
The study compared the Sapien to a newer version called Sapien XT that is smaller, thinner and thought to be safer
than the original. The late-stage study showed that the Sapien XT resulted in a slightly lower rate of death, disabling
stroke and serious procedural complications, meeting the study's endpoint of noninferiority. The results, expected by
analysts, will be considered preliminary for the next few weeks until a final analysis is completed. The results have
not yet been published in a peer-reviewed journal.
Over 12 months, patients given the new device had a 33.9% rate of death, disabling stroke and re-hospitalization
associated with the procedure, compared to 34.7% of patients receiving the Sapien. The study examined patients whose
aortic heart valves had calcified but were too sick to undergo surgery. Patients with the condition, known as aortic
stenosis, are at an extremely high risk of death.
The new device showed reduced procedural complications in both patient groups from prior studies of Sapien. The stroke
rate after 30 days, which had raised concerns in previous trials, was 4.3% in the Sapien XT device and 4.1% in the older
device. An earlier Sapien trial showed the stroke rate after 30 days to be 6.7%.
The stroke rate reduction was due to several factors, including better experienced proceduralists, and more rigorous
monitoring of risk factors like high blood pressure and atrial fibrillation, said Martin Leon, a principal investigator
in the trial and professor of Medicine at Columbia University College of Physicians and Surgeons. The trial also
excluded some inoperable patients for whom it was thought a new heart valve would not be beneficial.
However, there appeared to be a slightly higher re-hospitalization after 30 days in patients receiving the newer
device. The Sapien XT also showed a trend toward greater paravalvular leak, in which blood flows the wrong way in the
heart, a condition that puts patients at a high risk of death.
The company's Sapien line of heart valves are a class of medical devices known as transcatheter aortic valve
implantation, or TAVI, intended to replace the heart valves of mostly elderly patients who are unable or at a high risk
of undergoing traditional open-heart surgery. The devices use a small tube inserted through the groin or other access
routes to snake a valve-like device into the heart.
The devices are seen as a growth area in the medical devices industry, which has been battered in recent years by
shrinking markets in its core product areas such as implanted defibrillators and pacemakers. However, the TAVI market
faces challenges, including safety concerns, restrictive insurer reimbursement in the U.S. and austerity measures in
TAVI devices made by Edwards and Medtronic have been available in Europe since 2007, where the device approval process
is considered far less onerous than in the U.S. St. Jude Medical Inc. ( STJ ) had its heart-valve device approved there
last year and Boston Scientific Corp. ( BSX ) is seeking approval for its Lotus device there.
The devices's minimally invasive approach has excited many physicians and patients, but there is still not proof that
patients who are able to undergo surgery, which has a high success rate and a low complication rate, should opt for the
device. That's led many countries, including the U.S., to implement insurance reimbursement policies that limit off-
label use, which has kept the market from growing as quickly as some analysts had projected.
Write to Joseph Walker at firstname.lastname@example.org
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
Copyright (c) 2013 Dow Jones & Company, Inc.