* Device already approved for at-risk surgical patients
* Abbott seeks U.S. OK for patients at less risk
* Company: sales modest now, seen growing over time
* FDA panel to consider wider use of stent on Wednesday
(Adds details from documents, background on device, Abbott
comment, updates shares)
By Susan Heavey
WASHINGTON, Jan 24 Abbott Laboratories' (ABT.N)
RX Acculink carotid stent appears to work as well as surgery
in opening clogged neck arteries in patients who are not at
high risk for complications from the surgical procedure, U.S.
health regulatory staff concluded.
The device is already approved for patients who need to
have their neck arteries opened up, but would face greater risk
of side effects if they underwent a procedure to scrape off
built-up fatty deposits that can cause strokes.
Abbott is seeking Food and Drug Administration approval to
market its carotid stent for less-risky patients, saying it
offers another choice.
On Wednesday, an FDA advisory panel will consider the
request. The agency will later make the final decision.
Although doctors are already allowed to use the approved
device as they see fit, formal FDA clearance would allow the
company to legally promote wider use to physicians and patients
and seek greater sales.
Such neck stents are a small part of Abbott's vascular
business, and the overall carotid stent market is currently
growing at modest rates, Abbott Vascular spokesman Jonathon
"We anticipate an expanded indication and appropriate
reimbursement would broaden the use of the product, potentially
expanding the market over time," he said.
In documents released on Monday ahead of the panel's
meeting, FDA staff said the company-funded study, conducted in
part by the National Institutes of Health, overall was able to
prove that it was not any worse than the surgical alternative
known as carotid endarterectomy surgery.
However, staff reviewers said when looking more closely at
specific complications, stent patients had higher rates of
death and stroke while surgical patients had a higher rate of
In a separate memo, Abbott said the trial showed that its
Acculink stent overall was no worse than the alternative
surgery and that the trial "established a reasonable assurance
of safety and effectiveness."
Carotid stenting "is another treatment option for
patients," it wrote.
The trial, known as the Carotid Revascularization
Endarterectomy vs. Stenting Trial or CREST trial, looked at the
safety and effectiveness of stenting versus surgery in 2,502
patients and took nine years to complete.
Neck stents have raised some questions about which approach
is better -- stents or surgery. Stenting is a less invasive
procedure than surgery and involves threading the wire mesh
into the affected artery through a small incision.
In October, an analysis of 13 trials published in Achives
of Neurology found using a neck stent is more likely to cause
stroke or death compared to surgery, while surgical patients
are more likely to have nerve damage and heart attacks.
Researchers have said both approaches work and overall have
low rates of the differing complications. Which approach works
best could depend on the patient, although it is unclear which
individuals would be better suited to a certain therapy.
The FDA will ask its panel of outside experts on Wednesday
whether the benefits of Abbott's stent outweigh its risks.
Abbott's Hamilton also said if FDA approves the wider use,
the company will also seek expanded reimbursement coverage
through the nation's Medicare health insurance program for the
elderly and disabled.
Shares of Abbott were up 0.4 percent at $48.11 in early
afternoon trading on the New York Stock Exchange.
Other companies that also market carotid stent include
Boston Scientific Corp (BSX.N), C.R. Bard Inc (BCR.N),
Covidien's COV.N ev3 and Johnson & Johnson (JNJ.N).
(Reporting by Susan Heavey; Additional reporting by Julie
Steenhuysen in Chicago; Editing by Lisa Von Ahn, Dave Zimmerman
and Tim Dobbyn)