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MedicalDevice版 - The Eleven most implanted medical devices in America
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http://247wallst.com/2011/07/18/the-eleven-most-implanted-medic
11. Implantable Cardioverter Defibrillators
> Number of procedures: 133,262
> Total annual expenditure: $5.5 billion
> Average cost per procedure: $40,000
> Major manufacturer: Medtronic (40%), St. Jude Medical, and Boston
Scientific
Cardiac arrhythmia, or improper electric signaling in the heart, occurs in
millions of people a year. While the vast majority are benign, a select few
— usually in patients with a history of heart attack or heart failure —
can be fatal if not treated promptly. Implantable cardioverter
defibrillators (ICDs) are devices that monitor and treat these rhythms when
they are detected by sending a large jolt of electricity to the heart, and
basically pressing the reset button. Newer models can also function as
pacemakers, combining two devices into one. In 2009, according to the World
Society of Arrhythmias, 133,262 ICDs were implanted in the U.S., an increase
of 12% from 2005. Complications of ICDs are similar to their pacemaker
siblings: 1%-2% rates of infection and up to a 4% rate of lead failure.
While these devices are major life-saving technology, the U.S. Department of
Justice has been investigating the industry since March 2010 due to the
widespread practice of implanting the devices too soon after a major cardiac
event. One of the major manufacturers, Boston Scientific, acknowledged that
the investigation is likely to hurt sales in the short term. St. Jude
Medical, which is the second largest manufacturer behind Medtronic, was the
only one of the big three manufacturers to post an improvement in sales of
ICDs from 2009 to 2010, with total sales increasing 14% to $1.1 billion in
the U.S.
10. Artificial Hips
> Number of procedures: 230,000
> Total annual expenditure: $10.5 billion
> Average cost per procedure: $45,000
> Major manufacturers: Zimmer (24%), Stryker, DePuy/J&J, Biomet, Wright
Medical
As people age and gain weight the wear and tear on their joints builds up.
In particular, more than 20 million Americans suffer from degenerative
osteoarthritis, which is the leading cause of chronic disability in the U.S.
As one of three major weight bearing joints in the leg (the others being
knees and ankles), hips are put under a lot of stress over a lifetime. This
stress commonly leads to the wearing down of cartilage and the painful
friction of bone rubbing against bone. Hip replacement can lead to a
decrease in pain and an increase in mobility in over 90% of recipients. In
2007, the last reporting year, 230,000 procedures were performed, an
increase of 4.5% from 2003. Major complications are relatively rare at about
3% for first time procedures and 8% for revisions. But when friction or a
faulty manufacturing process wears down the replaced joint at a faster rate
than anticipated, replacement of the hip can be necessary earlier than
expected. In August 2010, DePuy of Johnson & Johnson recalled a hip
replacement system that had already been implanted in 93,000 patients
worldwide. The recalled joints failed in one out of eight patients after
only five years. These failures, in addition to requiring a new hip
replacement, can leave behind fragments that can become focal points for
infections, cause nerve and vessel damage, and possibly even lead to death.
Major class-action lawsuits have been filed, and it will be years before the
complete impact of this recall is known on DePuy and Johnson & Johnson.
This is likely good news for market leader Zimmer Holdings, which had
approximately $750 million in U.S. sales of hip replacements in 2010.
9. Heart Pacemakers
> Number of procedures: 235,567
> Total annual expenditure: $4.5 billion
> Average cost per procedure: $20,000
> Major manufacturers: Medtronic (40%), St. Jude Medical, Boston Scientific
As with ICDs, pacemakers are used to treat abnormal rhythms in the heart.
While ICDs treat otherwise fatal rhythms, pacemakers are used when the heart
’s internal clock is not maintaining a fast enough pace. Pacemakers
override the aberrant signals in the heart by passing small jolts of
electricity to multiple parts of the heart muscle, providing its own rhythm.
Modern pacemakers will increase with exercise and decrease with rest to
meet the body’s minute to minute needs. In 2009, according to the World
Society of Arrhythmias, 235,567 pacemakers were implanted in the U.S., an
increase of 5.5% from 2005. Complications of the surgery include a 1%-2%
rate of either short- or long-term infection and, more importantly, up to a
4% rate of lead malfunction. In 2005, Medtronic, the industry leader,
voluntarily recalled 40,000 pacemakers found to have a 0.17%-0.30% lifetime
failure rate, with approximately 100 known device failures found overall. In
the 2011 fiscal year, Medtronic posted $1.9 billion in worldwide sales of
pacing systems (approximately $1 billion in the U.S.). This was a slight
decline from the previous year caused by pricing pressures and a delay in
the FDA approval of Medtronic’s newest pacemaker system.
8. Breast Implants
> No. of procedures: 366,000
> Total annual expenditure: $992 million
> Average cost per procedure: $3,351
> Major manufacturers: Allergan, Mentor
Breast augmentation with implants is the most frequently performed plastic
surgery procedure in the U.S., beating out nose jobs (252,261), eyelid
surgery (208,764), and liposuction (203,106) by a significant margin. Over
296,000 procedures were done in 2010 for purely cosmetic reasons, with an
additional 70,000 done for reconstruction after a mastectomy, a rise of 39%
and 18%, respectively, since 2000. The American Society of Plastic Surgeons
reported $992 million spent on breast augmentation in 2010, but did not give
an amount for reconstructive surgeries. In the mid-1990s, Dow Corning
Corporation sought and received bankruptcy protection in the face of 19,000
silicone breast-implant sickness lawsuits. Due to the increased public
criticism, the FDA has since closely monitored breast implants in the U.S.,
with implants of only two companies currently approved by the FDA for
cosmetic use. Allergan, an independent pharmaceuticals company, which also
manufactures Botox, pulled in sales of $319.1 million from breast
augmentation. Sales numbers are unavailable for Mentor, a stand-alone
business unit of pharmaceutical giant Johnson & Johnson.
7. Spine Screws, Rods, and Artificial Discs (Spinal Fusion Hardware)
> Number of procedures: 413,000
> Total annual expenditure: $10 billion
> Average cost per procedure: $25,000
> Major manufacturer: Medtronic (35%)
Spinal fusion surgeries are performed for a variety of back problems, mainly
for pain and weakness. The surgery essentially fuses two or more vertebrae
with the help of hardware such as screws and rods. An alternative in a
number of these cases and a simpler procedure overall, decompressive surgery
removes part of the bone to free a trapped nerve. Despite evidence that
fusion is no more successful than the less costly decompressive surgery in
many cases, the frequency of fusion surgeries rose 111% from 1998 to 2008.
That’s compared to a 1.2% decline in decompressive surgeries over the same
period. While some of this increase may be warranted, a report published in
The Wall Street Journal in December 2010 revealed a troubling relationship
between some surgeons and the leading spinal device manufacturer, Medtronic.
The screws used in these surgeries to drill into bone cost less than $100
each to produce, while reimbursement comes out to between $1,000 and $2,000,
depending on the model. A manufactured bone-growth protein also used in
many of these surgeries sells for roughly $5,000 per pack. A surgery fusing
two vertebrae together can cost $15,000 just for the hardware. Patients of
these fusion surgeries are most likely to have the least amount of benefit.
A clinical trial now underway is comparing fusion and decompression should
have data reported in the next couple years. Hopefully, this will resolve
the controversy. In the meantime, Medtronic posted spinal hardware sales of
$3.4 billion worldwide during the latest fiscal year, $2.5 billion of which
from the U.S. market.
6. IUDs (Intra-Uterine Devices)
> No. of procedures: 425,000
> Total annual expenditure: $340 million
> Average cost per procedure: $800
> Major manufacturers: Teva Pharmaceutical Industries and Bayer HealthCare
IUDs are extremely popular worldwide and are the preferred method of
contraception for almost 25% of women in the rest of the developed world. In
the U.S., however, IUDs fell out of favor after a rash of problems with the
Dalkon Shield IUD in the late 70s and early 80s. Only 1%-2% of American
women were using the device in 2001. As of 2008, nearly 6% of American women
using contraception were using IUDs, and that number is likely to increase.
This month, the American College of Obstetrics and Gynecology released a
Practice Bulletin recommending IUDs and another implant as the most
effective reversible contraception — performing better than the pill, the
patch and the ring. The most serious complications associated with the
devices today are uterine perforation, which occurs in 0.1% of patients, and
pelvic inflammatory disease (PID), which occurs in 0.2% to 0.9% of patients
. Two forms of IUDs are available in the U.S., with an approximately even
split of market share: Paragard, a generic copper-coated IUD offered by Teva
Pharmaceutical Industries Ltd; and Mirena, a progesterone-releasing IUD
offered by Bayer HealthCare.
5. Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair)
> Number of procedures: 453,000
> Total annual expenditure: $4.5 billion
> Average cost per procedure: $2,000-$20,000
> Major manufacturer: Synthes (50%)
Bone fractures are one of the most common injuries, occurring in all age
groups for a multitude of reasons. Of over one million fractures that are
admitted to the hospital every year, roughly half require surgical
intervention to realign and stabilize the bone, a procedure called open
reduction and internal fixation. This procedure occurs on almost every bone
in the body, from tiny carpals in the wrist secured with plates no more than
half an inch long, to femurs (the largest bone in the body) requiring foot-
long rods, screws and pins to hold the bone together. In 2007, the last
reporting year, there were 453,000 procedures performed, an increase of 6.8%
from 2003. While the techniques and implants needed to perform these
surgeries on the different sites of the body vary widely, the provider of
those implant materials usually does not. Synthes has been the dominant
force in the market since the merger of Stratec Medical and Synthes USA in
1999. It brought in approximately $1.4 billion in U.S. sales of traumatic-
repair devices in 2010.
4. Artificial Knees
> Number of procedures: 543,000
> Total annual expenditure: $12 billion
> Average cost per procedure: $22,000
> Major manufacturer: Zimmer (24%), Depuy/J&J, Stryker, Biomet, Smith &
Nephew
As the other major, replaceable weight bearing joints in the leg, knees
frequently wear down faster and in a more disabling fashion than other
joints. The constant friction and shifting of weight in the joint leads to a
breakdown of cartilage and bone, making knees the most frequently replaced
joint in the body. Over 90% of total knee replacements lead to a reduction
or elimination of pain and an increase in mobility. Over the long-term,
there is a 10% failure rate (need for re-replacement) after 10 years, and a
20% failure rate after 20 years. While DePuy of Johnson & Johnson had a
minor recall of its knee products in 2008 without effecting implanted
patients, there has not been a major recall since Smith & Nephew’s “loose
joint” failure in 2003. Due to the relative stability of the knee market,
the five major manufacturers hold between 11% and 24% shares. In 2010,
Stryker reported approximately $750 million in U.S. sales of their knee
replacement products, a 10% increase from 2009.
3. Coronary Stents
> Number of procedures: 560,000
> Total annual expenditure: $7.5 billion
> Average cost per procedure: $13,000
> Major manufacturer: Boston Scientific (46%), Abbott Laboratories
Coronary stents are small tubes, usually coated with a drug (drug-eluting
stents), that are placed into the arteries that supply blood to the heart.
Stents are regularly implanted into patients with unstable angina (
unpredictable chest pain) and recent heart attack patients whose coronary
arteries have been partially blocked by atherosclerotic lesions (cholesterol
). In 2007, the last reporting year, 560,000 stent procedures were performed
, a decrease of 2.4% from 2003. Complications from stents include stent
thrombosis (clots), stent fracture, and re-occlusion (blood-vessel blockage)
. However, the risks of these complications are hard to quantify when
overall decrease in death and disability is taken into account. One of the
three major manufacturers, Johnson & Johnson recently decided to withdraw
from the market. Meanwhile, Boston Scientific, the owner of a 46% market
share as of 2010, has recently disclosed a new recall of 100,000 unimplanted
stents due to failure to deploy (those already implanted are not at an
increased risk of failure). These two events pose a great opportunity for
Abbott Laboratories, whose worldwide sales of stent products increased 18.6%
to $3.2 billion in 2010 compared to 2009.
2. Ear Tubes (Tympanostomy Tubes)
> Number of procedures: 715,000
> Total annual expenditure: $1 billion-$2 billion
> Average cost per procedure: $1,000-$4,500
> Major manufacturer: N/A
Otitis Media, or middle ear infection, is one of the most frequently
diagnosed childhood diseases with at least 80% of pre-school aged children
affected. Billions of dollars are spent every year on doctor visits,
medicines, and, in chronic cases, surgery. In 2006, the last reporting year,
there were 715,000 procedures performed, an increase of 40% over 10 years.
In contrast to the rise in numbers, multiple long-term studies have
concluded that as many as a third of these procedures are unnecessary. The
surgery itself, known as myringotomy and tube placement, is the most
commonly performed pediatric operation. It’s very safe, very quick, and has
very low complication rates. Due to the incredibly low cost of the tubes,
and the fact that they have been evolving for well over 50 years, no one
manufacturer appears to dominate the market.
1. Artificial Eye Lenses (Psuedophakos)
> No. of procedures: 2.582 million
> Total annual expenditure: $8 billion – $10 billion
> Average cost per eye: $3,200-$4,500, depending on lens type
> Major manufacturers: Alcon Laboratories/Novartis, Abbott Laboratories,
Bausch & Lomb
Cataracts are a problem faced by millions of elderly Americans yearly, many
of whom will require surgical replacement of their own lens with an
artificial one, known as a psuedophakos or intra-ocular lens. These lenses
come in many configurations, such as single-focus (like glasses for distance
vision), multi-focal lenses (like bifocal glasses), and hi-tech variable-
focus lenses (like real eyes). In 2006, the last reporting year, there were
over 2.5 million procedures performed — an increase of 43% over 10 years.
While the vast majority of cataract surgery is safe and effective, there is
a 1%-2% chance of retinal detachment over the rest of the patient’s
lifetime. If this occurs and is not treated promptly, patients can
completely lose their vision in the effected eye. While researchers are
examining non-surgical treatments for cataracts, surgery is currently the
only real treatment or cure. The market leader in intra-ocular lenses, Alcon
Laboratories, had sales of $1.2 billion in 2010. Alcon recently merged with
Novartis.
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