Collaboration to Develop Cardiac Patch

(Troy, MI, USA) and Performance Medical Devices (PMD, Vancouver, Canada). PMD is a developer of specialized medical products, including cardiac implant devices using bovine pericardium tissue.

PMD will help Somanetics design a new implant called the CorRestore patch, will perform clinical trials, and will manufacture the patch, which is for use in an evolving cardiac procedure called surgical anterior ventricular restoration (SAVR). In this procedure, the surgeon restores or remodels an enlarged, poor-functioning left ventricle to more normal size and function by inserting an implant in most cases or closing the defect.

Currently, surgeons fabricate an implant by hand, using off-the-shelf materials, which can result in an implant of variable quality. The new CorRestore patch is intended to standardize the implant and provide a nonclotting pericardium surface and a better-quality seal to minimize leaking. Somanetics has acquired an exclusive worldwide license to a patent relating to CorRestore. The company also manufactures and markets the Invos cerebral oximeter monitoring system.

PMD's development and manufacturing are done in accordance with ISO 9001 standards and the FDA's quality system regulation requirements for medical devices, assuring a high level of reliability and quality, said Bruce Barrett, president and CEO of Somanetics.