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Angel Medical Systems and Litron collaborate in product development.

Shrewsbury, N.J.-based Angel Medical Systems Inc. has tapped Agawam, Mass.-located Litron Inc. to build the Phase II implants for its Guardian implantable device.

Angel Medical Systems previously developed the AngelMed Guardian cardiac monitor and alert system, which detects and warns patients of acute episodes of cardiac ischemia related to the progression of coronary artery disease and thrombotic coronary occlusion caused by vulnerable plaque ruptures.

Angel Medical is running a Phase II clinical study of the investigational device in up to 75 sites throughout the United States. There currently are more than 200 patients participating in the study and will include more than 1,000 patients 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," said Steve Johnson, vice president, research and development at Angel Medical Systems.

"This particular device hits close to home," said Mark Plasse, president of Litron." 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."

Litron will manage the supply chain, develop the processes to systematically control the build, create job-specific tooling and test the investigational devices prior to final packaging and sterilization. Litron is expected to provide production units in January 2012.
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Title Annotation:Industry News
Publication:Medical Product Outsourcing
Date:Jul 1, 2011
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