Litron Inc. Selected to Build Implant Device

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 related to the progression of coronary artery disease and thrombotic coronary occlusion caused by vulnerable plaque ruptures.

Litron Inc. is a leading provider of laser welding/sealing services, medical device assembly and laser hermetic sealing systems for the medical device industry. With more than 14 years in business, Litron has built a facility well suited for the development of Class III Implantable Devices; from their Class 10,000 Cleanroom for assembly and final hermetic sealing to the laser services division for initial manufacturing, laser welding and cutting.

“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 company’s 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, Litron Inc.

“This particular device hits close to home,” says Plasse. “Being a recent heart attack survivor, I know what it’s like to not know if it will happen again. The potential for this device to not only get people to the doctor sooner, but give them peace of mind from day to day is invaluable.”

The Collaboration:
Angel Medical is fielding a Phase II Clinical Study of the investigational device in up to 75 hospitals/sites around the US. There are currently 200+ patients implanted in the study and will include upwards of 1,000 patients in the study through 2012.

“AngelMed was looking for a new manufacturer for our device, one with the skills and experience to do the job as well as one capable of meeting our growing needs. After a thorough search, we found Litron and we are confident we’ve chosen the right vendor for the job,” says Steve Johnson, vice president, Research & Development at Angel Medical Systems, Inc..

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. Through a well documented and thorough quality inspection process, Litron is poised to start providing production units as early as January of 2012.

“We’re excited to be moving forward with Angel Medical; knowing we’re working on an investigational device that can go a long way in preventing people from suffering from a massive heart attack,” says Michael Chmura, Medical Device Services Manager at Litron.