CustomBone
MaioRegen
Osteochondral Substitute
Lesions of the joint surface are a very common clinical challenge, frequently diagnosed also in young people. If untreated, they may degenerate into chronic, disabling conditions that can be addressed only by an invasive approach.
In most cases, an articular cartilage damage implies a simultaneous suffering of the sub-chondral bone structure. To guarantee the successful restoration of an healthy and functional joint, we should go “to the core of the problem”.
MaioRegen is a new therapeutic concept, inspired by nature. It promotes and guides an effective bone and cartilage regeneration, thus restoring the natural joint physiology.
“A system tailored to your patients’ needs”
MaioRegen is available in three different configurations:
- MaioRegen Prime for the treatment of osteochondral lesions with severely compromised subchondral bone
- MaioRegen Slim for the treatment of osteochondral lesions with slightly compromised subchondral bone
- MaioRegen Chondro+ for the treatment of cartilage lesions
MaioRegen
TECHNICAL SPECIFICATIONS
Composition and structure
MaioRegen is a multi-layered matrix, manufactured through a patented process.
The product, composed by collagen and hydroxyapatite enriched with magnesium, mimics the chondral and osteochondral tissues, both in the chemical composition and in the micro-structure.
MaioRegen is available in three different configurations: MaioRegen Prime, MaioRegen Slim and MaioRegen Chondro+ represent specific solutions for the treatment of the different phases of early phases of arthritic pathology.
Biomimetism
- Cartilage layer
- Calcified cartilage and sub-chondral bone layer
- Spongy bone layer
A) The damaged tissue is removed to create a suitable lodging to host the implant and guarantee an adequate blood flow from the subchondral bone
B) Maioregen fits perfectly into lesion site, restoring anatomic continuity
C) The biomimetic porous structure and the chimical composition favour cellular migration. The bone marrow-derived cells selectively adhere to the collagen fibres, colonizing the entire scaffold
D) Cells proliferate, differentiate and synthesize matrix according to scaffold layer composition. The progressive resorption of MaioRegen and the simultaneous cell mediated remodeling favour the complete regeneration of the tissue
MaioRegen
INDICATIONS
MaioRegen chondral and osteochondral substitutes are resorbable implantable medical devices indicated for the treatment of cartilage and osteocartilage lesions of the joint surfaces.
Lesions may be of traumatic, post-traumatic or degenerative origin, or resulting from osteochondritis dissecans.
MaioRegen Prime is indicated for the treatment of osteochondral lesions with severe subchondral tissue impairment, such as:
- traumatic, post-traumatic, degenerative lesions of grade IVa and IVb according to the ICRS classification;
- grade IV lesions according to the Outerbridge classification;
- early osteoarthrosis stage lesions (early OA as defined by Luyten, Knee Surg Sports Traumatol Arthrosc., 2012) and grade I and II lesions according to the Kellgren and Lawrence classification, in the absence of osteophytes;
- lesions resulting from osteochondritis dissecans.
MaioRegen Slim is indicated for the treatment of osteochondral lesions with moderate subchondral tissue impairment, such as:
- traumatic, post-traumatic, degenerative lesions of grade IVa according to the ICRS classification;
- grade IV lesions according to the Outerbridge classification;
- early osteoarthrosis stage lesions (early OA as defined by Luyten, Knee Surg Sports Traumatol Arthrosc., 2012) and grade I and II lesions according to the Kellgren and Lawrence classification, in the absence of osteophytes.
MaioRegen Chondro+ is indicated for the treatment of cartilage lesions with no or mild alteration of the subchondral tissue, such as:
- grade III traumatic and post-traumatic lesions according to the ICRS classification and grades III-IV ones according to the Outerbridge classification.
MaioRegen
SHAPES AND SIZES
Ready-to-use and easy to apply through a “one-step” procedure.
MaioRegen osteo-chondral substitute is available in single sterile packages.
| MaioRegen Chondro+ | |||||||
| Code | Description | Quantity | |||||
|---|---|---|---|---|---|---|---|
| 01600401 | 2,0 x 3,0 x 0,2cm | 1 | |||||
| 01600400 | 3,0 x 4,0 x 0,2cm | 1 | |||||
| 01600403 | Ø = 1,2cm H = 0,2cm | 1 | |||||
| 01600405 | Ø = 1,5cm H = 0,2cm | 1 | |||||
| 01600404 | Ø = 1,8cm H = 0,2cm | 1 | |||||
| MaioRegen Slim | |||||||
| Code | Description | Quantity | |||||
|---|---|---|---|---|---|---|---|
| 01600289 | 2,0 x 3,0 x 0,4cm | 1 | |||||
| 01600287 | 3,0 x 4,0 x 0,4cm | 1 | |||||
| 01600290 | Ø = 1,2cm H = 0,4cm | 1 | |||||
| 01600282 | Ø = 1,5cm H = 0,4cm | 1 | |||||
| 01600292 | Ø = 1,8cm H = 0,4cm | 1 | |||||
| MaioRegen Prime | |||||||
| Code | Description | Quantity | |||||
|---|---|---|---|---|---|---|---|
| 01600288 | 2,0 x 3,0 x 0,6cm | 1 | |||||
| 01600286 | 3,0 x 4,0 x 0,6cm | 1 | |||||
| 01600285 | Ø = 1,2cm H = 0,6cm | 1 | |||||
| 01600275 | Ø = 1,5cm H = 0,6cm | 1 | |||||
| 01600291 | Ø = 1,8cm H = 0,6cm | 1 | |||||
| MaioRegen Mini-Arthro Kit | |||
| Code | Description | Quantity | |
|---|---|---|---|
| 33109 | MaioRegen Mini-Arthro Kit | 1 | |
MaioRegen
CLINICAL EVIDENCE
To date, more than 7.000 patients have been treated with MaioRegen, which is considered an effective and safe treatment.
A randomized controlled clinical trial (RCT) vs. microfracture (Level of Evidence 1) shows a statistical significant improvement in the clinical scores (IKDC Subjective, Tegner, KOOS, VAS) at 2 years follow-up.
MaioRegen has proven to be superior to microfracture in the following indications: deep osteochondral lesions, osteochondritis dissecans (OCD) and in the population of sport active patients.
Deep Osteochondral Lesions (Outerbridge Grade IV)
Statistically significant superiority of MaioRegen vs. Microfracture (+12.4 points in change from baseline for IKDC subjective score).
Osteochondritis Dissecans (OCD)
Superiority of 12 points in change from baseline of MaioRegen vs. Microfracture in IKDC Subjective score.
Sport Active Patients
Statistically significant superiority of MaioRegen vs. Microfracture (+16 points in change from baseline for IKDC subjective score).
Superiority of MaioRegen treatment in these populations provides clear indications for the treatment of osteochondral lesions with MaioRegen Prime.
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CLINICAL STUDIES
