INDIVIDUALLY
CUSTOMIZED
Episealer® Femoral Condyle & Epiguide® - a patient-specific approach
UNIQUE
YOU ARE UNIQUE!
THEREFORE WE MAKE INDIVIDUALLY CUSTOMIZED IMPLANTS,
PERFECTLY PERSONALIZED TO EACH PATIENT, FOR THE BEST
RESULT
The Episealer® Femoral Condyle is an individually customized resurfacing implant intended for the knee
condyle for treatment of localized cartilage defects. This treatment is aimed at targeting patients
suffering from pain and reduced mobility due to cartilage damage in the knee. The treatment is
designed to eliminate pain and to enable recovery of the mobility of the joint.
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TO WHOM - a typical patient
Orthopaedic doctors often encounter the problem of providing an effective treatment for patients
between ages of 35 and 65 years, diagnosed with a focal cartilage lesion on the femoral condyle.
This category of patients are often too oldto effectively undergo biological treatments like
micro-fracturing or chondrocyte transplantation. Yet they are too young and active to undergo knee
replacement surgery.The Episurf Team has thus developed the Episealer® Femoral Condyle implant for
this group of underserved patients. It allows treatment of early stage focal cartilage damage by replacing the damaged area only. The ultimate goal of Episurf’s technology is to save patients from years of
pain by restoring the joint function, yet at the same time maintaing the possibility for future treatment
options.
The Episealer® Femoral Condyle implant is designed to offer an alternative for the patients
who might have endured years of pain and loss of knee joint function while waiting to reach
the appropriate age for joint replacement surgery.
Age <35 year
Age 35-65 year
Age >65 year
Characteristics of a typical patient intended for the Episealer Femoral Condyle implant:
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Middle aged
A cartilage defect, ICRs 3-4 only in one compartment
of the knee exposing subchondral bone, fully or partly,
causing pain and/or disability.
Cartilage defect located on the femoral condyle (medial
or lateral), either with primary degenerative etiology or
as a result of trauma.
Cartilage defect < 20 mm in diameter
No symptoms of instability of the knee
Standing X-ray should be normal
Arthroscopic picture of
cartilage defect
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Individually customized implants and surgical tools– enabling high
precision and apredictable surgery for optimal positioning of the
implant
Episurf provides a patient-specific system where the implant and surgical tools are individually
customized to the joint anatomy as well as to the size and position of the lesion. The Epiguide® is
designed to fit onto the condyle surface, allowing for a controlled removal of pathological tissue.
Thus maximum amount of healthy tissue is preserved, keeping options for future surgical choices open.
The Epiguide® matches the unique
curvature of the condyle
The Episealer® matches
the unique curvature of
the condyle
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Episealer® Femoral Condyle
Focal resurfacing implant
The Episealer® implant is customized to each
patient’s injury and joint anatomy, recreating
a smooth continuous weight bearing surface.
The Epiguide®
Surgical drill guide
A major component of the patient-specific
surgical tools is the Epiguide®. The guide is
designed to be attached onto the condyle
surface covering the lesion. This provides a
stable platform and support for which the
cutting and drilling process can be guided
accurately. A precise insertion of the implant at a
correct angle and depth is achieved and the risk
for a misangled or protruding implant is
minimized. The Epiguide® is used incombination
with the other modules of the Femoral Condyle
Tool kit.
Individually customized implants
and surgical drill guides enables:
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Pre-operative planning
An immediate recreation of joint surface
A precise implantation
A prefect matching implant
A controlled implantation
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Areas where it is possible to place the Episealer® implant.
Episealer® – Sizes
The Episealer® is available in four different
diameters: 12, 14, 17 and 20 mm, depending
on the condyle and lesion size.
Implants scale 1:1
A patient-specific approach
The patient–specific designs of the Episurf implants and surgical drill guides are based upon MRI
imaging. By processing the MRI data, a 3-dimensional model of the damaged joint is recreated.
The lesion is identified and the implant and surgical drill guide are designed to enable the replacement
of the damaged area with a perfectly fitting implant.
The use of individually customized tools increases the precision of the surgical
procedure enabling an optimal positioning of the implant.
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The image to implant process
The entire process of producing a patient-specific implant together with surgical instruments is managed
by the μiFidelity® system. μiFidelity® ensures that the correct implant is delivered to the clinic site at
the time of surgery. It is a web-based system that accounts for the entire process from MRI imaging of
the joint to delivery of the patient-specific implant and the
corresponding surgical tools.
μiFidelity®
The process starts by having the patient
undergo an MRI scan. The scanned file is
then uploaded to the μiFidelity® system
through μiClinic®, a web based online
order management system. The MRI-data
are subsequently transferred to Episurf’s
imaging center, where the design of the
patient-specific Episealer® and Epiguide®
is carried out.
μiClinic®
The surgeons will get access to μiClinic®
for transferring of patient-specific MRI
data and finally ordering of patientspecific implants and surgical tools.
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BECAUSE YOU ARE UNIQUE
Stora Skuggansväg 11 | 115 42 Stockholm | [email protected]
1726-5MA006-01