A developer of electro-spinning equipment and supplier of related services to the medical device industry, IME Medical Electrospinning (Waalre, Netherlands) announced today the launch of the MediSpin XL platform. The system is designed for the industrial production of reproducible and scalable fiber-based scaffolds for Class I, II and III medical devices. The company describes the technology as a global breakthrough in the controlled, large-scale production of well-defined scaffolds for implants and membranes using fibers in the nanometer to micrometer scale.
IME’s advanced equipment uses specific polymers to create fiber-based medical implants that mimic the natural human extracellular matrix. Human cells recognize the implants as the body’s own tissues and organs, facilitating the repair of damaged tissue in heart valves, blood vessels, nerves, tendons, skin and bone and so forth. Traditional implants and membranes may cause a foreign body response and be rejected or lead to scar tissue.
The electro-spinning process is governed by a number of variables that are crucial for success in research and development as well as large-scale manufacture, notes IME Medical. Parameters such as fiber diameter and structure, porosity, mesh thickness and tensile strength are vital for the functionality of the device in either in vitro or in vivo environments, but they have been challenging to control. In particular, changes in temperature and relative humidity can lead to inconsistencies within one batch as well as between batches.
The MediSpin XL platform eliminates distortions in the electro-spinning process, enabling optimal process set-up and improving stability. Climate control and on-line quality monitoring measurements ensure a consistent end product. Downstream processes such as cutting and blistering can be easily added to the system. Automation minimizes the need for operator intervention, which further adds to a reproducible process and minimizes the potential for product contamination.
The introduction of this platform further strengthens the company’s global standard for the joint development and production of scalable and reproducible nanometer and micrometer scaffolds, said IME. With a recently commissioned high-end laboratory and ISO Class 7 cleanrooms, IME is now able not only to develop and manufacture its proprietary electro-spinning equipment, but also produce scaffolds on a contract basis for medical implants.