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Transcript
The Major Costs of Minor Miracles:
Technology on the Horizon
Stacy M. Borans, MD
Chief Medical Officer
Advanced Medical Strategies
Learning Objectives
For Medical Devices
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Understand their clinical indications
Know the mechanisms of action
Be able to anticipate their costs
Understand the cost-benefit ratios
Be aware of new(er) technologies
on the horizon
In the News…
Girl doing well after transplant
Before finding the donor organ,
a Berlin pump kept her alive.
The Food and Drug Administration gave
emergency approval for the hospital to bring
a pump and backup unit from Germany.
Introduction
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Health care spending consistently
increases at
a rate of approximately 7.5%
Health care premiums have also increased
at the same rate
Fifteen medical conditions account for the
majority of the growth in healthcare
spending
20-40% of that growth can be attributed
to new technology developments
Obesity
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Obesity: Body mass index (BMI)
between 30 and 39
Morbid obesity: BMI greater than 40
Increased risk of hypertension, diabetes
mellitus, coronary artery disease, breast
and colon cancer and gallbladder disease
Americans classified as such: 60 million
Obesity:
Implantable Gastric Stimulator
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Intended for patients with a BMI between
30 and 55 who have failed conventional
weight loss treatments
Pacemaker-like device
Device induces the feeling of fullness
(satiety)
Mechanism of action is not well understood
Obesity:
Implantable Gastric Stimulator
Obesity:
Implantable Gastric Stimulator
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Implanted under the skin of the abdomen
Leads and electrodes are inserted into the
stomach wall and fastened to the muscle
Activated approximately 30 days after
implantation
Minimally invasive and can be performed
in the outpatient setting
Obesity:
Implantable Gastric Stimulator
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Early Results: 30% of baseline weight lost
Weight loss maintained for 3 years
Estimated cost of $10,000
• includes stimulator and leads
Additional Costs for implantation
Long term benefits are the reduction of
the comorbid conditions
Degenerative Disc Disease
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Extremely Common Cause of
Low Back Pain (LBP)
Loss of water content in discs causes
two vertebrae to move closer together
Conservative treatment is first-line
Severe cases require surgery: spinal fusion
Rods
 Screws
 Back Cages
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Degenerative Disc Disease:
Charité Artificial Disc
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Patients with only one diseased disc
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between L4 and L5 or
between L5 and S1
Fail six months of conservative treatment
Cannot be used in patients with DDD at
more than one level
Patients cannot have osteopenia or
osteoporosis
Degenerative Disc Disease:
Charité Artificial Disc
Degenerative Disc Disease:
Charité Artificial Disc
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Diseased disc removed and replaced with
artificial disc
Restore proper disc height between the
vertebrae above and below the disc
Maintain motion in the area of the spine
where the disc is implanted
Re-establish proper spinal alignment/
curvature of the lumbar spine
Degenerative Disc Disease:
Charité Artificial Disc
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Lack of long-term follow up studies
Invoice Price for the device is $11,500
Procedure costs for a single disc are
$30,000 to $45,000
Long Term Benefits over spinal fusion
were primarily greater flexibility
Coronary Artery Disease
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Leading cause of death in both
women and men
Earlier detection allows for
better outcomes
Evaluate risk factors and recommend
appropriate testing
Typically requires invasive methods to get
most accurate clinical picture
Coronary Artery Disease:
64 Slice CT scanner
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FDA Approved in 2004
Cost to the facility: $1.8 million/scanner
Ability to non-invasively image the heart in
extreme detail
Ultrafast
May be able to use in ER to assess and
discharge
Coronary Artery Disease:
64 Slice CT scanner
Coronary Artery Disease:
64 Slice CT scanner
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Patients will still require cardiac cath
Expense: $1000-$2000 per scan
May have other applications
Inappropriate use risks exposure to
substantial radiation
Currently still in clinical trials,
but anticipate widespread use
Congestive Heart Failure
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Five million people in the US suffer from
heart failure.
End stage CHF has very limited treatment
options
Only 2,500 cardiac transplants completed
per year due to organ availability
Left ventricular assist device used as
bridge to transplant
Congestive Heart Failure:
AbioCor Implantable Replacement Heart
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Strict Patient Criteria
End stage heart failure
 Life-expectancy of less than 30 days
 Not heart transplant candidates
 Have no other viable treatment options
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Patients are not candidates for LVAD or
will not benefit from LVAD insertion
Congestive Heart Failure:
AbioCor Implantable Replacement Heart
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Multiple Components of device
Internal Components: artificial ventricles,
hydraulic pumping system, rechargeable
battery and electronics package
External Components: external console or
battery packs
Congestive Heart Failure:
AbioCor Implantable Replacement Heart
Congestive Heart Failure:
AbioCor Implantable Replacement Heart
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Inpatient Implantation
Patients placed on cardiopulmonary
bypass
The diseased heart is replaced and
the Abiocor is connected to the native
blood vessels
Implantation of the transcutaneous energy
transfer coil, controller, and battery pack.
Congestive Heart Failure:
AbioCor Implantable Replacement Heart
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Currently in trials at selected centers
No long term studies available to assess
either safety or efficacy of the device
FDA Advisory Panel rejected application to
widen use in 2005
Cost estimates are $200,000-$250,000 for
the total implantation
Cerebrovascular Disease
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Strokes have an annual incidence of
700,000
75% of strokes are due to ischemic
infarcts
80% of ischemic infarcts are due to large
vessel occlusion by atherosclerosis
Time to treatment is critical in preventing
significant disability for affected patients
Cerebrovascular Disease:
MERCI Retrieval System
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FDA Approved in 2004
Indicated for removal of blood clots from
patients experiencing an ischemic stroke
Late Onset Presenters
Also used to remove foreign bodies in
the peripheral, coronary, and
neuro vasculature
Cerebrovascular Disease:
MERCI Retrieval System
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System consists of Merci Retriever,
microcatheter and balloon guide catheter
Retriever is designed to engage and
capture the occlusive thrombus (clot)
Microcatheter is designed for placement
of fluids and/or other devices or agents
into vessels
Balloon provides temporary vascular
occlusion during the procedure
Cerebrovascular Disease:
MERCI Retrieval System
Cerebrovascular Disease:
MERCI Retrieval System
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Clot location confirmed by angiography
Balloon guide catheter is inserted into
the femoral artery and guided via x-ray
to the carotid artery.
Retriever ensnares the clot, balloon guide
catheter is temporarily inflated and the
clot is withdrawn
Main goal is to reopen the artery before
there is permanent neurologic damage.
Cerebrovascular Disease:
MERCI Retrieval System

Clinical trial outcomes were good in
select patients
National Institutes of Health Stroke Scale score
(NIHSS) greater than or equal to 10
 Treatment performed within 8 hours from
symptoms’ onset
 Occlusion of a major cerebral artery on
the angiogram
 Contraindication to intravenous TPA (clot buster)
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Cerebrovascular Disease:
MERCI Retrieval System
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Further studies in larger patient
populations are needed
No reports of device related complications
Personnel training is needed
Estimated cost of the device is $9,000
Other devices being evaluated for
the treatment of stroke
Prostate Cancer
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Affects 1:6 men
Predominantly a disease of older men
African American men are 61% more likely
to develop prostate cancer
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2.5 times more likely to die of the disease
Family history contributes to risk
Early Stage disease can be cured
Prostate Cancer:
Robotic Prostatectomy
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Minimally invasive surgery
Performed from a computerized
workstation
Robotic arms perform the necessary
movements including:
Hold and position an endoscope
 Grasp, cut, dissect and cauterize
 Suture tissue
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Prostate Cancer:
Robotic Prostatectomy
Prostate Cancer:
Robotic Prostatectomy
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Computer-enhanced system provide:
3-D view of the surgical field, including depth of
field, magnification and high resolution
 Instruments that are designed to mimic the
movement of the human hands, wrists and fingers
 Master controls that allow the surgeon to
manipulate the instruments
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Magnifies the surgical field up to 15 times
Shorter hospital stay and less
postoperative pain
Questions/Comments
Thank you for attending!