Initial Clinical Experience With A Novel Spectroscopy Catheter That Can Identify Lipid-core Coronary Plaques

Main Category: Cardiovascular / Cardiology
Also Included In: Blood / Hematology;  Medical Devices / Diagnostics
Article Date: 10 Oct 2008 - 3:00 PDT

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There is an unmet need for a method to identify lipid-core coronary plaques, the structures associated with most heart attacks and not detectable by conventional coronary angiography. On April 25, 2008 the U. S. FDA granted clearance to InfraReDx, Inc. for marketing of its LipiScan(TM) System to identify lipid core containing coronary plaques. Dr. Daniel Schultz, Director of the FDA Center for Devices and Radiological Health, stated in an FDA press release that: "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." An article describing the scientific validation of the device was featured on the cover of the September, 2008 issue of the JACC Imaging, an official publication of the American College of Cardiology.

Following this validation and FDA clearance, five leading cardiovascular centers in the United States adopted the system and used it for routine clinical care in over 50 patients undergoing coronary artery disease stenting procedures. These physicians will report on their initial experience with the device in multiple presentations at the Transcatheter Cardiovascular Therapeutics (TCT) Conference to be held in Washington DC from October 12 to 16, 2008. The TCT is the world's leading meeting for those performing coronary diagnostics and stenting.

The system permits the performance of spectroscopy, which is widely used to determine chemical composition of unknown materials, to be performed inside the coronary artery of a living patient. Dr. Craig M Gardner, Director of Algorithm Development at InfraReDx and lead author of the validation manuscript explained that: "NIR spectroscopy is sensitive to the chemical composition of tissue, can penetrate through several millimeters of blood, and can collect measurements rapidly through thin and flexible optical fibers."

On Monday, October 13 at 7AM, InfraReDx will sponsor: "Beyond Angiography: Near-Infrared Spectroscopy and Other Methods for Plaque Characterization." This symposium examines the SPECTACL trial, the search for vulnerable plaques, clinical imperatives for plaque characterization, and lesion interrogation.

Also on Monday, October 13, the NIR system will be described by Dr. Muller at the TCT sponsored Vulnerable Plaque Symposium.

In addition to the general presentations, there will be the following presentations describing specific features of the LipiScan system:

-- Near-Infrared Spectroscopic Measurement of Lipid-Core Coronary Plaque Length: Implications for Complete Lesion Coverage in Patients Undergoing Stenting - Simon Dixon, Presentation on Monday, October 13 at 12:24PM in Room 152A.

-- Relationship of the Near Infrared Lipid Core Burden Index in Coronary Segments with Traditional Risk Factors in Patients Undergoing PCI - John Peterson, Poster

-- Lipid rich plaque identified by near infrared spectroscopy is associated with plaque shift in bifurcation lesions: An observation from the SPECTACL study - J. Goldstein, Case Study, Poster

-- Use of the Block Chemogram to Interpret the Near Infrared Spectroscopic Signs of Lipid Core Containing Coronary Plaques - C. Gardner, InfraReDx, Inc. TCT Poster

The LipiScan(TM) Coronary Imaging system will be displayed in the company's TCT 2008 booth (#1414 on level 2).

"The InfraReDx team is pleased that the LipiScan 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," says James E. Muller, M.D., cardiologist, co-founder and CEO of InfraReDx, Inc.

About InfraReDx Inc.

InfraReDx Inc. is a privately held medical device company located in Burlington, Massachusetts. InfraReDx is dedicated to improve patient care through development of its core optical technologies for the diagnosis and treatment of cardiovascular disease.http://www.infraredx.com

About TCT 2008

Now in its 20th year the Transcatheter Cardiovascular Therapeutics symposium, sponsored by the Cardiovascular Research Foundation, will take place at the Washington Convention Center in Washington, DC from Sunday October 12 through Friday October 17, 2008.

InfraReDx Inc.