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Published on: November 15, 2013
The Molteno M-Sphere
D R Jordan1, I Hwang, S Brownstein
1Department of Ophthalmology, University of Ottawa Eye Institute, Ontario, Canada.
Purpose:
To analyze a mammalian hydroxyapatite (HA) implant known as the Molteno M-Sphere, recently approved by the Food and Drug Administration of the United States.
Methods:
The authors examined the implant macroscopically, with chemical analysis (x-ray powder diffraction, x-ray fluorescence spectrophotometry), and microscopically with scanning electron microscopy. Animal implantation of six Molteno M-Spheres was carried out in six adult male New Zealand albino rabbits. Implant vascularization was evaluated by means of magnetic resonance imaging and histopathologic sectioning.
Results:
The M-Sphere was found to have multiple interconnected pores throughout with an average pore size of 300 microm to 600 microm. This implant was very light-weight (0.31 g) and fragile. It was made up of pure HA. Magnetic resonance imaging studies showed implant enhancement to its center by 4 weeks after implantation. Histopathologically, fibrovascularization occurred uniformly throughout the 4, 8, and 12-week rabbit implants.
Conclusions:
The M-Sphere is an alternative type of HA implant that recently has been reintroduced into the United States for use after enucleation, evisceration, or as a secondary implant. It has multiple interconnected pores allowing central fibrovascularization as early as 4 weeks in a rabbit model. Its light weight and fine trabecular framework, however, are associated with increased implant fragility when compared with other available HA implants (BioEye and FCI3 synthetic HA). The implant requires careful handling because routine handling may damage the implant. The implant is currently approved by the United States Food and Drug Administration.
Insights
The Molteno M-Sphere, a hydroxyapatite (HA) implant, offers central fibrovascularization within 4 weeks in rabbits. However, its lightweight nature makes it fragile and requires careful handling.
Area of Science:
- Biomaterials Science
- Ophthalmology
- Surgical Implants
Background:
- Hydroxyapatite (HA) implants are used in ophthalmic reconstructive surgery.
- The Molteno M-Sphere is a recently FDA-approved HA implant.
Purpose of the Study:
- To analyze the physical, chemical, and biological properties of the Molteno M-Sphere HA implant.
- To evaluate its potential for fibrovascularization and compare its characteristics to other HA implants.
Main Methods:
- Macroscopic, chemical (XRD, XRF), and microscopic (SEM) analysis of the implant.
- Animal implantation in New Zealand albino rabbits.
- Evaluation of vascularization using MRI and histopathology.
Main Results:
- The M-Sphere is a lightweight, pure HA implant with interconnected pores (300-600 microm).
- MRI showed central enhancement by 4 weeks; histopathology confirmed uniform fibrovascularization.
- The implant is fragile compared to other HA implants, necessitating careful handling.
Conclusions:
- The M-Sphere is a viable HA implant option for ophthalmic reconstruction, promoting early central vascularization.
- Its porous structure facilitates fibrovascular ingrowth.
- Implant fragility is a key consideration, requiring meticulous handling during surgical procedures.
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