Agawam, Mass. – Litron Inc. has been selected by Angel Medical Systems Inc., Shrewsbury, N.J., to build the Phase II implants for its Guardian implantable device.
Litron has built a facility well suited for the development of Class III implantable devices – from its Class 10,000 Cleanroom for assembly and final hermetic sealing to the Laser Services Division for initial manufacturing, laser welding, and cutting.
Litron will be managing the supply chain, developing the processes and procedures to systematically control the build, create job specific tooling and full assembly and testing of the investigational devices prior to final packaging and sterilization. Litron is poised to start providing production units as early as January 2012.
"Over the years, Litron has worked on nearly every aspect of medical devices from developing welding parameters and statistically validating processes to showing companies how to weld their devices and building laser systems for medical companies’ in-house use. Now we’re taking that knowledge and experience and putting it towards the full assembly of medical devices for our customers," says Mark Plasse, president of Litron Inc.
Angel Medical Systems has developed the AngelMed Guardian cardiac monitor and alert system designed to detect and warn patients of acute episodes of cardiac ischemia. The company was looking for a new manufacturer with the skills and experience to build the device. After a thorough search, Angel found Litron, and it is confident the right vendor has been chosen.
Litron is a provider of laser welding/sealing services, medical device assembly and laser hermetic sealing systems for the medical device industry.