InfraReDx reports first patient use of LipiScan Coronary Imaging System

June 2, 2008 -- InfraReDx Inc.'s LipiScan system, recently cleared by the FDA to identify the lipid core (fatty) plaques associated with complications of coronary stenting, was used for the first time by doctors at Beaumont Hospital (Royal Oak, Mich.) to assess the chemical composition of coronary plaques in a patient undergoing cardiac catheterization.

June 2, 2008 -- InfraReDx Inc. says physicians at Beaumont Hospital in Royal Oak, Mich., have successfully used its LipiScan Coronary Imaging System in a patient undergoing a cardiac catheterization. This is the first patient in the world in whom it has been possible to assess the chemical composition of coronary artery plaques and use such information to assist in the management of coronary artery disease.

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 percent 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.

"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," said Dr. Daniel Schultz, Director of the FDA Center for Devices and Radiological Health.

"If doctors can identify these fatty plaques, we can recommend better treatment options to patients," says Simon Dixon, M.D., 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 (tiny mesh "scaffold" to hold an artery open) 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 U.S. Food and Drug Administration approved the LipiScan Coronary Imaging System in late April.

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