First use of infrared laser imaging system to analyse coronary artery plaque

2 June 2008

The InfraReDx LipiScan coronary imaging systemPhysicians at a hospital in Michigan have successfully used InfraReDx, Inc's LipiScan coronary imaging system in a patient undergoing a cardiac catheterisation. The system is a catheter-based device that uses infrared laser light to detect how much fat and other substances are contained in a plaque.

InfraReDx says the patient is the first in the world in whom it has been possible to assess the chemical composition of coronary artery plaques and utilize such information to assist in the management of coronary artery disease.

Dr Daniel Schultz, Director of the FDA Center for Devices and Radiological Health, has stated, "This is the first device that can help assess the chemical make-up of coronary artery plaques and help physicians identify those plaques with lipid cores, which may be of particular concern."

Physicians at Beaumont Hospital performed the procedure on May 8, 2008 in a 70-year old male patient. The LipiScan System revealed the presence of a lipid core containing plaque not detectable by conventional diagnostic measures.

This fatty plaque was located near a narrowing that required a coronary stent for the usual reasons. Because of the presence of this plaque, the physicians selected a stent that was 50% longer than the one that would have been used to cover the narrowing only.

This longer stent covered the lipid core containing plaque and avoided placing the end of a shorter stent in the fatty plaque. Termination of a stent in a fatty plaque has been associated with clotting of the stent years after placement.

"If doctors can identify these fatty plaques, we can recommend better treatment options to patients," says DrSimon Dixon, director of the cardiac catheterization laboratories and co-director of cardiac research at Beaumont, Royal Oak. "This information tells us immediately what length of stent to use and where to place it in patients with severe narrowings. Based on further research, this novel device may help determine which type of stent — bare metal or drug-eluting — is best for the patient."

"The InfraReDx team is pleased that the LipiScan Coronary Imaging System has been validated in tissue samples and a clinical study and has been cleared by the FDA for use in patients. We understand the great potential of interventional cardiology and anticipate that this novel tool will assist physicians with the complex decisions they face in the management of patients with coronary artery disease," said James  Muller, MD, cardiologist, co- founder, President and CEO of InfraReDx, Inc.

"There is a real unmet medical need to identify lipid core containing plaques of interest in the coronary arteries, which before now we could not do," said James Goldstein MD, an interventional cardiologist and consultant to InfraReDx. "The ability to detect lipid core containing plaques of interest may go a long way in providing information to help prevent heart attacks in the near future."

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