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J&J to Present Radiation Heart Device to FDA Panel Monday
J&J to Present Radiation Heart Device to FDA Panel Monday
Washington, June 16 (Bloomberg) -- Johnson & Johnson, the world's No.
1 maker of medical devices, will ask a U.S. government panel Monday
to back what could be the first radiation device available in the
U.S. for preventing new clogging after an artery- opening procedure.
J&J is seeking the backing of a Food and Drug Administration advisory
panel for its Checkmate device, which J&J sees as the next step in
improving results of a heart procedure called angioplasty. Advances
from J&J and its rivals already have made this procedure, involving
just a small incision in the groin, an alternative to open-heart
surgery for many patients.
That has generated a $2 billion a year market in stents, tiny mesh
tubes used to prop open arteries after angioplasty, and analysts
expect radiation devices to generate as much as $750 million more in
annual sales for companies making the systems.
``It's the most exciting thing since stents,'' said Jeffrey Moses,
chief of interventional cardiology at New York's Lenox Hill Hospital,
who helped test the Checkmate device and was one of the first doctors
to try stents.
Guidant Corp. and Novoste Corp. expect to follow J&J to the U.S.
market with similar radiation devices that would have advantages to
the J&J machine. Still, all of these machines could be quickly
supplanted if J&J and its rivals succeed in developing a drug-coated
stent that would do the same job and prevent new clogging.
``We use what works,'' Moses said after speaking in support of the
J&J device at a meeting where legislation was proposed to speed
Medicare payment of new medical equipment, such as the radiation
device.
The CheckMate device is intended to apply radiation to the fast-
growing cells that respond to stenting, keeping the new growth in
check. Studies indicate the Checkmate device reduces the rate of new
clogging in arteries by about 40 percent. J&J rival Novoste Corp.
introduced a similar device outside of the U.S. and J&J and Guidant
Corp. have followed in some markets.
`Carpet of Cells'
In angioplasty, doctors use a balloon-tipped catheter to push back
deposits in arteries and insert stents to keep the arteries open. The
body then should grow a ``carpet of cells'' to keep the device in
place, said Paul Teirstein, a cardiologist who has used the Checkmate
device.
``What we're looking for is a Berber carpet,'' said Teirstein, who
practices at Scripps Clinic in LaJolla, California and at Lenox Hill
Hospital in New York. ``Some patients form a shag carpet.''
That ``shag carpet'' of new cells can lead to new narrowing in
arteries after angioplasty and stenting, a condition that occurs in
about one-third percent of angioplasty patients, according to
American Heart Association.
Safety Questions
For J&J to get a head start in the U.S. market, analysts said it
likely will have to answer questions about cases of blood clots
thought to be to caused when radiation delays healing around the
stent. Some doctors have said this can be avoided by changing the
dose of radiation and the drugs given to patients.
``What the panel will want to see is that J&J has proven that late
stent thrombosis is not a problem,'' said Robert Faulkner, an analyst
at Chase H&Q, who said the company may have enough data to reassure
the panel about the device's safety. ``It is possible that they've
done enough patients . . . that they can make the case that its
safe.''
Even if the panel backs the device and the agency approves it,
analysts expect that many hospitals may wait to see the devices that
J&J's rivals will put on the market. The machines from Novoste and
Guidant use a different form of radiation, beta. Novoste's device
takes only three to five minutes to use, and hospital personnel can
stay in the room during the procedure. J&J's system, which uses a
different type of radiation, takes longer to use, and medical
technicians must leave the area.
J&J faced a similar battle in the U.S. in the mid-1990s after it
pioneered use of stents. J&J largely created the market, though
Guidant Corp. and other rivals came along with better versions of the
tiny tubes, and J&J lost much of its market share.
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Sandy Perle Tel:(714) 545-0100 / (800) 548-5100
Director, Technical Extension 2306
ICN Worldwide Dosimetry Division Fax:(714) 668-3149
ICN Biomedicals, Inc. E-Mail: sandyfl@earthlink.net
ICN Plaza, 3300 Hyland Avenue E-Mail: sperle@icnpharm.com
Costa Mesa, CA 92626
Personal Website: http://www.geocities.com/capecanaveral/1205
ICN Worldwide Dosimetry Website: http://www.dosimetry.com
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