IN THE PIPELINE: Less Is More In Boston Sci Stent Plans
09 Giugno 2009 - 5:30PM
Dow Jones News
In a quest for new medicated heart stents, Boston Scientific
Corp. (BSX) is aiming for as little medication as possible.
To maintain its heavyweight position in the more than $4 billion
market for the tiny heart-artery scaffolds, Boston Scientific must
keep pace with a push for stents that still use drugs to keep
arteries from reclogging, but don't require long courses of
anti-clotting pills.
The Natick, Mass., company recently bought Labcoat Ltd. for this
reason. Rather than slathering on polymers and the drugs they
attach, the Labcoat system works like an inkjet printer to put tiny
amounts where needed.
Medication that stops scar tissue provoked by stent deployment
from narrowing arteries is only needed initially. Labcoat devices
are designed to shed all their polymer and drug in a matter of
months, allowing modest cell coverage to keep stent struts from
catching blood cells and creating clots.
"We want to explore the lower limit of drug to get us as close
to a bare-metal stent as we can, but maintain the efficacy" of
medicated stents, said Keith Dawkins, Boston Scientific's associate
chief medical officer.
Doctors see challenges in striking the right balance, and the
technology needs validation. But Bernstein Research analysts said
they believe Boston Scientific will "become the leading player in
the wave of next-generation stents" with polymers that get absorbed
by the body.
Labcoat technology can be used on any stent, and Boston
Scientific hasn't fully outlined its commercialization goals.
Bernstein believes the company - which competes with Abbott
Laboratories (ABT), Johnson & Johnson (JNJ) and Medtronic Inc.
(MDT) - could reach Europe by late 2009 with Labcoat technology on
"Taxus Liberte" stents it already sells, should the company go that
route.
Boston Scientific does plan to use Labcoat on a new stent it's
developing called Taxus Element, which would come later. It's also
studying Labcoat and an internally developed bioabsorbable polymer
on stents using the drug "everolimus" and will commercialize one of
them.
Early drug-coated stents work well at stopping scar tissue that
can lead to repeat procedures, but they put in unnecessary
overtime, according to Renu Virmani, a pathologist and well-known
critic of coated stents.
Indeed, carpet bombing vessels with drugs while polymers stick
around forever may boost the chances for dangerous clots, a
realization that badly damaged the stent market in 2006. While the
market has regained traction, doctors typically keep patients on
the drug Plavix for at least a year to ward off clots.
That is expensive and can create bleeding risks. Boston
Scientific wants stents with Labcoat technology that, like
bare-metal stents, require anti-clotting drugs for just a month,
Dawkins said.
Virmani thought early stage Labcoat study results looked good.
But she remains cautious because she believes the drug "paclitaxel"
on Boston Scientific's older stents - which it will continue using
on new devices - has an unproven track record when used in minute
amounts.
Virmani, who is also president and medical director of the
CVPath Institute in Maryland, which researches heart disease, has
studied how the body responds to stents.
Medicated devices are used today in about three-quarters of U.S.
stent procedures, and bare-metal stents are used when patients
aren't likely to stick with anti-clotting drugs. It will take clear
evidence that new coated stents are safe without those drugs to
notably grow usage, said Fred Resnic, who directs the cardiac
catheterization laboratory at Brigham and Women's Hospital in
Boston.
The industry is chasing this goal.
J&J has a stent in testing that also sheds its polymer and
becomes a bare-metal device. Called "Nevo," the J&J device
performed well in a study matching it up against a Boston
Scientific stent and could hit Europe in 2010.
Abbott is working on devices made entirely of material the body
can absorb once scaffolding is no longer needed. Some smaller
companies including Biosensors International Group Ltd. (B20.SG),
meantime, are already selling metal stents overseas with
bioabsorbable polymers.
Regarding the competition, Boston Scientific's Dawkins noted the
company sees fully bioabsorbable stents like Abbott's as a likely
future technology, but "further down the line." He also noted that
the Labcoat technology will use one-tenth the drug and polymer
J&J is using on its Nevo stents.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com