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Friday, July 25. 2008
Read Original Link Here
By
BARRY MEIER July 24, 2008
Zimmer Holdings, the nation’s biggest producer of
orthopedic devices, says it will suspend sales of an
artificial hip component that some doctors have
complained was failing at a high rate.
The company also lowered its earnings outlook as a
result of the suspension, and its shares fell sharply
Wednesday. In recent months, some doctors have complained that
the device, a hip socket known as the Durom cup, was
failing in their patients, who then had to undergo
replacement surgery. Zimmer said its investigation had determined that the
product was not defective. But it stated that even some
experienced surgeons had found it difficult to implant.
The company said it expected to resume sales once
specialized training for doctors had begun. Since it was first sold in the United States in 2006,
the Durom cup has been implanted in more than 12,000
patients. Zimmer said it expected the overall need for
early replacement in patients would be low. But Zimmer
data and interviews with doctors suggest that hundreds
of patients might need such procedures in coming years. Some doctors said their patients had not had problems
with the cup. The company also said the sales halt would cut $20
million to $30 million from its sales estimates. Zimmer
said it expected that earnings for the year would be
$4.05 to $4.10 a share, down from its earlier forecast
of $4.20 to $4.25 a share. In composite trading on the New York Stock Exchange,
shares of Zimmer, which is based in Warsaw, Ind., fell
$4.87 a share to close at $66.01 a share. Bruce Nudell,
an analyst at UBS who covers medical devices, said that
the company had not issued any warnings that sales would
be halted. “They had given hints that there would not be a
recall but this came as a surprise,” Mr. Nudell said. The issue with the device surfaced in April when a
surgeon in Los Angeles, Dr. Lawrence Dorr, publicly
warned other orthopedists about cup failures his
patients were experiencing. In response, Zimmer said it
would start an investigation but said it saw no reason
to take added action like halting sales. At the time, Zimmer also cited European data showing
that the device was doing well there. But the version of
the device used outside the United States is slightly
different from the one used here. Also, while doctors
here use it in traditional hip replacement, surgeons in
other countries used it in a relatively new kind of hip
surgery known as resurfacing, which involves somewhat
different surgical techniques. Zimmer, which announced the sales suspension late
Tuesday, said that its investigation found that using
the cup required a higher degree of precision. Dr. Dorr, who said he had stopped using the device
last year, said he did not plan to start reusing it. “It is a bad design,” he said. Mr. Nudell, the analyst, said that other doctors were
happy with the cup, but he expected that Zimmer might
see a 50 percent drop in the product’s use when sales
resumed. As a result of halting sales, Zimmer said that it was
also suspending United States premarketing trials of its
system for resurfacing, the process that is used in
Europe. That decision will put it further behind
competitors that already have such products on the
American market.
Friday, July 25. 2008
July 23, 2008Original Link -
Click HereZimmer Holdings Inc.'s (ZMH) U.S. sales suspension
for "Durom" replacement hip parts will further delay progress in
bringing a bone-sparing hip system to the U.S. market, which could
benefit smaller competitors. Zimmer announced Tuesday that it has
temporarily stopped selling Durom parts - which are cups used to make
replacement hips - because U.S. surgeons need retraining to avoid
problems. Since Durom is part of a so-called hip resurfacing system
Zimmer is studying now, and hoped to bring to the U.S. in a few years,
Zimmer also halted the U.S. resurfacing study. "We are suspending
enrollment until further notice," said Cheryl R. Blanchard, senior vice
president of research and development and chief scientific officer at
Zimmer, during a conference call with analysts Wednesday. Due to the Durom suspension, "there will be some delay
beyond that 2011 period that we earlier referenced" for a
hip-resurfacing rollout, added James T. Crines, Zimmer's chief financial
officer. By preserving bone for potential future surgeries, hip
resurfacing is seen as a market-expanding technology that could bring
younger patients into the nearly $5 billion global replacement hip
market. Thomas Weisel analyst Raj Denhoy believes resurfacing sales
could represent 10% of total replacement hip sales in the U.S. by 2012.
Smith & Nephew PLC (SNN) won Food and Drug Administration approval in
May 2006 to bring the first modern resurfacing system to the U.S. Corin
Group PLC ( CRG.LN), another U.K. firm, won FDA approval for its system
last summer, but uptake has been slowed by issues at Stryker Corp. (SYK),
which is marketing Corin's device in the U.S. The Corin product
slowdown has benefited Smith & Nephew, and signs that industry
heavyweight Zimmer won't be marketing a competitive product as soon as
hoped is another positive development. Shares of Smith & Nephew, which
Piper Jaffray upgraded to buy from neutral on Tuesday, recently traded
up 1.4% to $57.74.
Zimmer officials did not estimate a new timeline for when a resurfacing
system might roll out in the U.S. On the company's first-quarter
earnings call in April, Crines said 2011 was the earliest date,
following some other delays in the program. He also said that Zimmer's
sales, marketing and product development efforts would remain focused on
the other 90% of the replacement hip market in the near-term. He
reiterated that plan on Wednesday's call. Wright Medical Group Inc. (WMGI)
is another potential beneficiary from Zimmer's delay if it can finally
secure approval for its resurfacing product. Wright has been in
regulatory limbo at the FDA for years and hasn't explained the reason,
although management has said the company still expects approval.
Wright has a better chance to capitalize in the near term by seeking to
capture some lost Durom business from Zimmer, because Wright has similar
technology. Shares of the company recently traded 3% higher to $31.10.
Zimmer shares, hurt by the Durom issue and a cut to 2008 guidance,
recently traded down 5.5% to $66.94. -By Jon Kamp, Dow Jones
Newswires
Tuesday, July 15. 2008
http://www.signonsandiego.com/uniontrib/20080715/news_1c15alivem.html
July 15, 2008 SAN
DIEGO ALIVE
With more people in their 40s and early 50s being
sidelined by severe osteoarthritis, a new technology – hip resurfacing as an
alternative to hip replacement – is giving baby boomers a chance to stay active
longer.
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Robyn Benincasa, a runner and San Diego
firefighter, had a new hip resurfacing procedure.
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The Birmingham Hip Resurfacing system takes only the
cartilage off the outer part of the ball and socket joint, and installs a
cobalt-chromium steel cap and cup that slides more smoothly than hip
replacements, lasts longer and has less potential for leg-length
discrepancy. Widely used in the U.K. since 1997, the BHR system was approved
for use in the U.S. in May 2006.
This week, San Diego Alive, the Union-Tribune's
video health feature, spotlights local adventure racer and San Diego
firefighter Robyn Benincasa, who, under the care of La Jolla orthopedic
surgeon Dr. Michael Kimball, had the procedure. Five months after Kimball
resurfaced Benincasa's troublesome hip, she ran across Vietnam.
Monday, July 14. 2008
Read complete article by clicking here
May 1, 2008 By Avery Comarow
If he could have, Brad Barnum would have kissed the ground when he climbed
out of the car in Ruidoso, N.M., at the end of March. But the 53-year-old
building contractor had undergone major remodeling himself—and his new knee and
two new hips ruled out kneeling for a few more weeks. Still, he was ecstatic.
More than two months after leaving for the hospital, he was home, and he had
afforded the otherwise unaffordable. By having the work done in India, at
Wockhardt Hospital in Bangalore, he'd gotten his new joints for just $23,000.
Even after adding about $5,000 for airfare, passport, visa, and incidentals, the
total was nearly 80 percent less than the $125,000 or more he easily could have
been charged by a U.S. hospital. And that bill wouldn't have included physician
fees and "ancillary charges."
Barnum is one of thousands of Americans—estimates range from an
ultraconservative 5,000 to 500,000 annually if minor procedures are counted—who
are leaving the States for surgery when they have to come up with funds
themselves. They may be self-employed or work for a small business and lack
health insurance, for example, or their procedure may not be covered. More than
1 in 4 workers earning at least $60,000 a year went without insurance in 2006,
according to a Census Bureau survey; too well-off to be eligible for medical
assistance, they can often wring tens of thousands of dollars out of hospital
"rack rates" by going abroad. Some employers and big insurers like UnitedHealth
and Blue Cross and Blue Shield are so intrigued by "medical tourism" that
they're beginning to sniff for signs that it might be smart to cover it. "I was
totally amazed not just at the quality of the medical care but at the quality of
the service," says David Boucher, an assistant vice president of healthcare
services at BlueCross BlueShield of South Carolina who has visited many
facilities abroad. "The initial driver may be price, but patients' positive
experiences will do a lot to advance the movement."
So far, there's been mostly talk, with little action from employers and health
carriers. In fact, the first verified case of major surgery abroad as an
employee benefit took place only earlier this year. (The patient reportedly paid
nothing out of pocket for a knee replacement—in fact, the company, a North
Carolina manufacturer, paid him a tidy sum for saving so much money.) Wockhardt,
where the procedure was done, won't name the company.
Meanwhile, patients are finding their way abroad on their own. Wockhardt's
hospitals in Bangalore and Bombay operated on about 850 U.S. patients in 2007,
more than double the 2006 total. In Thailand, Bangkok's Bumrungrad Hospital says
it treats more than 38,000 Americans a year—a somewhat inflated figure that
represents "patient encounters," not individual patients, and includes
expatriates. Other hospitals in India and Thailand, as well as centers in
Singapore, are actively courting Americans, and the governments of South Korea
and Taiwan are about to launch campaigns.
Low-budget dentistry, Botox-ing, lipo, and other cosmetic work have for years
drawn Americans into Mexico and to other Latin American countries. But the
growth in serious elective surgery halfway around the world is new. Josef
Woodman, who publishes the Patients Beyond Borders series of guidebooks to
finding good care, thinks about 50,000 patients a year leave the country for
major noncosmetic elective procedures such as joint replacement, coronary artery
bypass, new or repaired heart valves, or back repair.
Many, like Barnum, do the legwork on their own. But concierge services like
MedRetreat.com and IndUShealth.com are multiplying, to help with lists of
potential hospitals, appointment scheduling, arranging airport pickup and
drop-off, and general hand-holding. (Information from Woodman's annual hospital
survey has been incorporated into the World Hospital Finder, a U.S. News search
tool for people who are seeking care abroad.)
Read Complete Article by clicking here
Saturday, July 12. 2008
Pseudotumours Risk For Hip Resurfacing Highlights Need For Regular
Clinical Follow-up For New Devices
Link
http://www.medicalnewstoday.com/articles/114601.php
July 11, 2008
As the incidence of metal-on-metal hip resurfacing has increased in recent
years, especially in younger patients, research published in the Journal
of Bone and Joint Surgery - British Volume (JBJS-Br) discusses
occurrences of "pseudotumours" as a result.
The researchers estimate that approximately 1% of patients who have
metal-on-metal hip resurfacings develop pseudotumours within five years of
treatment. A pseudotumour is 'a soft-tissue mass associated with the
implant…neither malignant nor infective in nature', but that causes pain and
discomfort to the patient.
Most worryingly for patients and doctors is that the causes of the tumours
are unknown. The research discusses possible causes including 'toxic
reaction to an excess of particulate metal wear debris.' The article
stresses the need for further research to be done into the incidence of
pseudotumours in patients who have had this treatment.
The paper concludes that the incidence of pseudotumours must be related to
metal-on-metal hip resurfacing highlighting 'the need for regular clinical
follow-up for new devices'. Such follow-up would follow NICE
recommendations, but the current NHS climate makes this difficult, if not
impossible, to achieve.
Read the research abstract
Notes
- The Journal of Bone and Joint Surgery - British Volume is a world
leading orthopaedics journal with an Impact Factor of 1.868
- JBJS-Br publishes twelve issues a year of high-quality,
peer-reviewed research, overseen by an international editorial board led by
Editor James Scott
- The Journal was first published in 1948 by The British Editorial
Society of Bone and Joint Surgery, a registered charity (No. 209299), with
the object of the advancement and improvement of education in orthopaedic
surgery and allied branches of surgery and the diffusion of knowledge of new
and improved methods of teaching and practicing orthopaedic surgery in all
its branches
- You can find out more about the Journal at
http://www.jbjs.org.uk
Journal
of Bone and Joint Surgery, British Volume
Saturday, July 12. 2008
Link
http://www.medicalnewstoday.com/articles/114601.php br> 11, 2008
As the incidence of metal-on-metal hip resurfacing has increased in recent
years, especially in younger patients, research published in the Journal
of Bone and Joint Surgery - British Volume (JBJS-Br) discusses
occurrences of "pseudotumours" as a result.
The researchers estimate that approximately 1% of patients who have
metal-on-metal hip resurfacings develop pseudotumours within five years of
treatment. A pseudotumour is 'a soft-tissue mass associated with the
implant…neither malignant nor infective in nature', but that causes pain and
discomfort to the patient.
Most worryingly for patients and doctors is that the causes of the tumours
are unknown. The research discusses possible causes including 'toxic
reaction to an excess of particulate metal wear debris.' The article
stresses the need for further research to be done into the incidence of
pseudotumours in patients who have had this treatment.
The paper concludes that the incidence of pseudotumours must be related to
metal-on-metal hip resurfacing highlighting 'the need for regular clinical
follow-up for new devices'. Such follow-up would follow NICE
recommendations, but the current NHS climate makes this difficult, if not
impossible, to achieve.
Read the research abstract
Notes
- The Journal of Bone and Joint Surgery - British Volume is a world
leading orthopaedics journal with an Impact Factor of 1.868
- JBJS-Br publishes twelve issues a year of high-quality,
peer-reviewed research, overseen by an international editorial board led by
Editor James Scott
- The Journal was first published in 1948 by The British Editorial
Society of Bone and Joint Surgery, a registered charity (No. 209299), with
the object of the advancement and improvement of education in orthopaedic
surgery and allied branches of surgery and the diffusion of knowledge of new
and improved methods of teaching and practicing orthopaedic surgery in all
its branches
- You can find out more about the Journal at
http://www.jbjs.org.uk
Journal
of Bone and Joint Surgery, British Volume
Wednesday, July 9. 2008
Link
http://www.orthosupersite.com/view.asp?rid=29416
By Gina Brockenbrough
July 2008
DENVER — Patients with foot and/or ankle surgical wounds who are taking COX-2
inhibitors may have a significantly higher incidence of delayed wound healing
than those not taking the medication, according to new research presented here.
To evaluate the potential impact of COX-2 inhibitors on surgical wound healing,
Chad Lamoreaux, MD, and colleagues performed a retrospective study of all foot
and ankle patients operated on by a single surgeon using the same wound care
plan during a 3-year period. The investigators excluded patients with
pre-existing foot and ankle wounds and those with a history of chronic ulcers.
The results were presented at the American Orthopaedic Foot and Ankle Society
24th Annual Summer Meeting.
Of the 175 patients included in the study, 12.6% had delayed wound healing,
which the investigators defined as a postoperative delay, infection, wound sloth
or lesion that was followed for a period in the wound care clinic. Of the total
study group, 18 patients were on preoperative standing doses of COX-2
medications, which included either celecoxib or rofecoxib.
The investigators discovered that nine of the 18 patients taking a COX-2
inhibitor had delayed wound complications compared to only 13 of the 157
non-COX-2 patients. While the groups were similar regarding demographics such as
age and gender, a closer examination revealed a non-equal distribution of
patients with diabetes and tobacco use.
After excluding patients with these risk factors, the investigators found that
only six of the remaining 150 non-COX-2 patients had wound-healing complications
(4%) compared to four out of the 13 remaining COX-2 patients (31%).
"[We] did make several assumptions to do this paper," Lamoreaux said during his
presentation. "The distribution of Celebrex (celecoxib, Pfizer) vs. Bextra (valdecoxib,
Pfizer) was not looked at. Also, the usage of the nonspecific anti-inflammatories
was not looked at. But with the normal patients, our findings still showed a
very significant impact of COX-2s on their ability to heal their surgical
wounds."
For more information:
Lamoreaux C, Santrock RD and Deemer J. COX-2 inhibitors and wound healing
complications. Presented at the American Orthopaedic Foot and Ankle Society 24th
Annual Summer Meeting. June 26-28, 2008. Denver.
Tuesday, July 8. 2008
Link
http://www.newsweek.com/id/46170
July 2006
At 42, Sally Seeley was barely able to walk. Diagnosed with osteoarthritis in
her late 20s, she tried a range of treatments from water aerobics to Vioxx. But
her condition only got worse. Finally, an orthopedic surgeon recommended total
hip replacement. She worried that she was too young for such surgery, but she
just couldn't stand the discomfort any longer. "The pain was gone immediately,"
says Seeley, now 49. Three months ago, she had her right hip done; she's already
back at work.
Joint replacement was once considered a last resort for elderly patients who
were immobilized. Now, thanks to improved artificial joints made from
longer-lasting materials like titanium, patients in their 50s and younger are
signing up in growing numbers. More than 600,000 hip and knee replacements were
performed in the United States last year. While the average patient was well
over 60 years old, the number of people younger than 65 getting the surgery has
grown by 20 percent over the past five years. "Maybe 10 or 15 years ago, the
threshold was the ability to walk or do errands," says Dr. Edwin Su, an
orthopedic surgeon at the Hospital for Special Surgery in New York. "Now it's
continuing to ski, golf or windsurf."
Doctors compare joint replacement to replacing tires on a car that's out of
alignment. Over the decades, your weight can wear down your bones. This is
especially true for patients with arthritis, where inflammation destroys the
cartilage surrounding the joint, causing the bones to grind together painfully.
In knee replacements, the most common joint-replacement procedure, doctors cut
into the joint and remove the damaged portions of the tibia (the lower leg
bone), patella (kneecap) and femur (thigh bone). They are replaced with metal
and plastic components. The surgery lasts at least two hours and requires
general anesthesia. Artificial knees generally last from 10 to 15 years. Hips
are the second most commonly replaced joints, followed by shoulders...
Tuesday, July 8. 2008
June 2008
Link
http://www.nbc11.com/msnbchealth/16748813/detail.html
Timmi Ryerson, a San Diego stock market analyst, says her left hip actually
works again, thanks to an orthopedic specialist in India.
...What's new about these procedures is not the exotic locales the three
chose, but the way they paid for their far-flung surgeries.
While at least 150,000 Americans travel abroad for medical care every year,
according to the American Medical Association, Ryerson, Mason and Davies
represent a small but growing category of medical tourist: patients whose
insurance companies have agreed to foot at least part of the bill.
"I think that's the solution to our health care crisis," said Davies, 53, whose
company plan, Delta Dental, maxed out his dental benefit, about $2,500, toward
the $30,000 he spent to repair damage caused by years of grinding his teeth, a
procedure that would have cost an estimated $80,000 in the United States.
Increasingly, some of the nation's larger employers and leading health insurers
agree.
Once the province of the poor and uninsured, medical tourism is gaining
attention of industry giants such as CIGNA, Aetna and Blue Cross/Blue Shield,
who say they either have begun or are considering pilot programs that provide
limited coverage for foreign care. One Montana firm, Employee Benefit Management
Services Inc., recently began offering medial tourism plans to its 120
self-insured clients in the Northwest...
"I just think that others need to be aware that they are able to have a safe
procedure done out of the country for a price at a third the cost," she said.
Ryerson, 61, said her private Blue Cross plan paid 80 percent of a $7,000 hip
resurfacing surgery in Chennai, India, that would have been about $55,000 in the
U.S. - if she could get it at all.
In 2006, the hip resurfacing device necessary for her surgery had just been
approved for U.S. use by the federal Food and Drug Administration and not many
domestic doctors had experience with it. Dr. Vijay Bose, her U.K.-certified
surgeon in India, had performed the surgery more than 1,100 times.
"Doctors here didn't know what they didn't know and I didn't want to be a guinea
pig," she said.
While she was there, Ryerson also had cosmetic surgery and dental work done at
her own expense...
Tuesday, July 8. 2008
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