MaioRegen (EN)
Osteochondral Substitutes
INSTRUCTIONS for USE
DESCRIPTION
MaioRegen is a reabsorbable, implantable medical device indicated for the
treatment of cartilage injuries involving the subchondral bone structure. This
osteochondral substitute is composed of type I collagen fibre (of equine origin)
containing hydroxyapatite (HA) crystals, materials that are physiologically present
in the organism and hence do not alter the articular biochemical balance.
MaioRegen comes in the form of a composite matrix whose gradient mimics the
entire anatomic osteocartilaginous compartment: the surface part reproduces the
cartilage, while the deeper layer reproduces the subchondral bone structure.
Thanks to its unique configuration and biomimetical properties, MaioRegen can
promote the regenerative processes of damaged osteocartilaginous tissue.
AVAILABLE FORMATS
The device is available in different shapes and sizes and in the following
configurations:
-
MaioRegen (three layers)
MaioRegen Slim (two layers)
INDICATIONS for USE
MaioRegen is indicated for the treatment of single or multiple grade III or IV
(Outerbridge classification) osteochondral defects with severely compromised
bone, caused by:
o
trauma
o
post-trauma
o
degenerative processes
o
osteochondritis dissecans
or injuries from early osteoarthrosis (as defined by Luyten et al., Knee Surg Sports
Traumatol Arthrosc. 2012) classified grade I and II (absence of osteophytes)
according to the Kellgren and Lawrence classification.
MaioRegen Slim is indicated for the treatment of single or multiple grade III or IV
(Outerbridge classification) chondral and osteochondral defects with slightly
compromised bone, caused by:
o
trauma
o
post-trauma
o
degenerative processes.
The device must be used for osteocartilaginous defects smaller than 10 cm 2.
The device acts as an osteochondral graft that is reabsorbed during the
remodelling process of the newly-formed osteocartilaginous tissue.
Because of its high porosity and hydrophilicity, MaioRegen encourages rapid
absorption of the biological fluids with which it comes into contact and its
adaptation to the implant site.
It is recommended to apply some fibrin glue to increase the mechanical stability of
the device, especially if using MaioRegen Slim.
INSTRUCTIONS for USE
Below are the instructions for surgical use of MaioRegen and MaioRegen Slim.
Apply the device using the arthrotomy technique.
Preoperative treatment.
It is advisable to perform pre-operative X-ray and MRI examinations for
appropriate evaluation of the injury characteristics (location, size, subchondral
bone and cartilage quality) and the joint involved.
The patient must undergo prophylactic antibiotic therapy prior to surgery.
In patients allergic to specific antibiotics, a substitutive prophylaxis should be
considered.
Intraoperative aspects.
The device is intended exclusively for surgical use under sterile conditions.
Apply a tourniquet to the proximal region of the patient’s thigh.
Open the device package only in a sterile field after checking that it is intact.
Expose the area of the osteochondral injury by arthrotomy incision.
In order to ensure the mechanical stability and effectiveness of the device,
prepare a housing with regular contours using an appropriate surgical instrument.
Where necessary, shape the device based on the geometry of the prepared
housing using a surgical scalpel for the cartilaginous layer and surgical scissors
for the remaining part or only surgical scissors.
Handle the device with care while shaping it.
Make sure that you shape the device so that it is not larger than the housing.
Place the device in the prepared housing making sure that its rough surface is in
contact with the bone part and that the smooth cartilaginous surface faces
upwards. Exercise light pressure by hand.
Make sure that the edges of the device are in contact with the receiving tissues
and that they perfectly adapt to the housing. Release the tourniquet. Device
stabilization is facilitated by bleeding of the subchondral bone. It is recommended
to further stabilize the device by applying fibrin glue on the following parts:
- the edges of the device before the housing and at the interface between the
device and the articular cartilage after the implant (if using MaioRegen in threelayer configuration).
- at the interface between the device and the articular cartilage after the implant (if
using MaioRegen Slim in two-layer configuration).
Instructions for use(EN____________) - Code MPA 000620-41-02
MaioRegen Osteochondral substitutes – MaioRegen Slim
Release the tourniquet.
Check the stability of the device by flexing and extending the joint repeatedly.
Close the surgical site according to standard procedures.
Postoperative treatment.
In accordance with surgical procedures, the patient must undergo a suitable
postoperative antibiotic therapy. In patients allergic to specific antibiotics, a
substitutive prophylaxis should be considered.
Inform the patient of the rehabilitation treatments and therapies necessary for a
proper post-operative course.
Do not immobilize the limb after surgery.
It is advisable to periodically check the treated site by means of NMR.
CONTRAINDICATIONS
Do not use the device in case of:
systemic or localised infection;
inflammatory or autoimmune disease;
hypercalcemia;
degenerative bone disease;
coagulation disorders;
metabolic disorders;
ongoing antineoplastic chemotherapy;
diabetes;
obesity (Body Mass Index, BMI  30);
osteochondral defects exceeding 10 cm2;
coinciding injuries;
age under 15 years and over 60 years;
alterations or complications of thyroid function;
systemic conditions affecting wound healing;
known allergy to equine collagen and calcium phosphate salts
USE IN SPECIFIC SUBJECTS
MaioRegen effects are unknown in case of:
renal disease;
pregnancy;
breastfeeding;
ongoing radiotherapy;
neoplasia;
cardiovascular diseases.
WARNINGS
MaioRegen is intended to be used by qualified orthopaedic surgeons only.
In the event of allergic reaction, remove the device and perform an appropriate
therapeutic treatment.
It is unadvisable to apply the device by means of mosaicplasty technique.
Avoid arthroscopic procedures at the implant site during the month following the
operation.
Do not use the product if the packaging is damaged. Open the package carefully
to prevent damaging the device. Do not use the product after its expiry date. The
device cannot be re-sterilized.
Should the device be removed during the intra-operative stage, do not reuse it.
Use a new device.
Avoid the dispersion of device particles outside the implantation site.
MaioRegen is a single-use device. Do not use any remains for other operations
but dispose of it as contaminated hospital waste according to the regulations in
force at the hospital facility.
The package contains some labels bearing the traceability data of the product;
these should be applied on the patient’s clinical record.
The factors listed below should be considered when selecting the device and/or
the therapeutic approach:
 patient age;
 quality of the bone and cartilaginous tissues;
 defect location;
 load conditions;
 joint alignment.
Repair of the defect treated with the device may lead to an unsatisfactory result in
terms of regeneration of new osteochondral connective tissue. The result depends
on the patient’s individual response to the treatment and on patient’s compliance
with the postoperative rehabilitation protocol.
PRECAUTIONS
When placing the device in the housing prepared in the osteochondral tissue,
make sure that its rough surface is in contact with the bone part and that the
smooth cartilaginous surface faces upwards.
In order not to compromise the porosity of the device, do not use an excessive
amount of product and do not overcompress the device once positioned in the
defect area. MaioRegen does not guarantee post-implantation mechanical
support, therefore an adequate ambulatory device is recommended.
POSSIBLE COMPLICATIONS
During the post-operative phase, some complications related to the type of
intervention may occur, such as prolonged swelling of the treated area,
hyperthermia, joint adherences and/or fibrosis.
STERILIZATION
All MaioRegen formats are supplied sterile (sterilized by 25 kGy gamma rays).
This product is intended for single use and must not be re-sterilized.
Its reuse, in whole or in part, may involve the risk of cross-contamination and the
risk of infection at the implant site.
STORAGE
Store the product in a cool and dry place away from light and heat sources (+10
°C / + 30 °C).
Ed./Rev.: 03/0 dated 03/03/2015
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Manufacturer:
FIN-CERAMICA FAENZA S.p.A.
48018 Faenza (RA) - ITALY
Administrative office:
Via Granarolo, 177/3
Manufacturing site:
Via Ravegnana, 186
info@finceramica.it
Do not resterilize
Manufacturer
Batch code
Do not reuse
Catalogue number
Do not use if the package is damaged
Number of pieces
Sterile, including the method of sterilization
(ionizing radiations)
Use by
Warning: see the instructions for
use
Consult the operating instructions
CE marking
Instructions for use(EN____________) - Code MPA 000620-41-02
MaioRegen Osteochondral substitutes – MaioRegen Slim
Ed./Rev.: 03/0 dated 03/03/2015
Page 2/2