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Brochure MaioRegen MDU006003-02-00 2023 EN ST2
Brochure MaioRegen MDU006003-02-00 2023 EN ST2
MaioRegen Slim
MaioRegen Prime
* All products cleared for CE marketing (regulation EU 745/2017)
Not yet FDA approved
A SYSTEM
TAILORED TO YOUR PATIENTS’ NEEDS
MDU 006003-02-00
Fin-Ceramica Faenza Spa
via Granarolo 177/3 - 48018 Faenza RA, Italy
t +39 0546 645411 - f +39 0546 46763
Guarda il video info@finceramica.it - www.finceramica.it
is a joint surface restoration system for the treatment PILOT CLINICAL STUDY Results from a Level of Evidence I international RCT*
of cartilage and osteochondral lesions, with a comprehensive range of
solutions for all the pre-osteoarthritis stages, and supported by the highest •Kon E. et al., AJSM, 2011 - 28 Patients - 2 years follow-up The study has been conducted to assess the benefit provided by MaioRegen Prime (tri-layer) scaffold.
•Kon E. et al., AJSM, 2013 - 27 Patients - 5 years follow-up
level of scientific evidence. •Di Martino et al., AJSM 2021 - 24 Patients - 10 years follow-up IKDC SUBJ. SCORE
Available in three different configurations, each for a specific indication, 2 YEARS FUP
MaioRegen is a biomimetic resorbable device ready to use and easily Demographic and lesions data 90
p < 0.0001
implantable through a straight-forward surgical approach. • 28 Patients: 19 ♂ - 9 ♀
• Mean age (years ± SD): 35.3±10.2
LESIONS SITES 67.5
Statistical significant improvement in IKDC
• Average lesions size: 2.9 ± 1.3 cm2 Subjective Score for patients treated with
LFC; 5
• Lesions aetiology: o 6 OCD MaioRegen from baseline to 2 years follow-up.
45
o 17 Microtraumatic/degenerative Patella; 12
o 5 Traumatic 66.7
2 YEARS FUP
80 8 60
+12.4 points vs Microfracture in change from
3
70 7 77.7
40 baseline of IKDC Subjective score.
Prime Osteo-chondral lesions with severe bone
60
50
6
5
64.3
impairment. 40 4
20
30 3
20 2
0
40.5 77,0 78,6 78,0 MAIOREGEN MICROFRACTURES
10 1 n = 27 n = 30
0 0
0
MAIOREGEN MICROFRACTURES
From Discussion: n = 16 n = 11
“The main finding of this study is that this cell-free biomimetic osteochondral 100
2 YEARS FUP
60
“A significant improvement of the clinical scores was observed at long-term follow- +12.0 points vs Microfracture in change from
76.7 baseline of IKDC Subjective score.
40
up after surgery, regardless of the number of previous or concurrent surgical 61.9
20
procedures. Considering the variety of characteristics of this heterogeneous
1+ 2 3 group of patients, this series can closely represent the real clinical setting of 0
MAIOREGEN
n = 15
MICROFRACTURES
n = 12
middleaged patients presenting with articular surface lesions who can obtain an
Cartilage defects Osteo-chondral defects Advanced OA overall benefit from this technique.” Clear Clinical Indications: RCT analysis in above sub-populations confirms the superiority of MaioRegen compared to microfracture.