BURLINGTON, Mass., Oct. 9 There is an unmet need for amethod to identify lipid-core coronary plaques, the structures associated withmost heart attacks and not detectable by conventional coronary angiography.On April 25, 2008 the U. S. FDA granted clearance to InfraReDx, Inc. formarketing of its LipiScan(TM) System to identify lipid core containingcoronary plaques. Dr. Daniel Schultz, Director of the FDA Center for Devicesand Radiological Health, stated in an FDA press release that: "This is thefirst device that can help assess the chemical make-up of coronary arteryplaques and help physicians identify those plaques with lipid cores, which maybe of particular concern." An article describing the scientific validation ofthe device was featured on the cover of the September, 2008 issue of the JACCImaging, an official publication of the American College of Cardiology.
Following this validation and FDA clearance, five leading cardiovascularcenters in the United States adopted the system and used it for routineclinical care in over 50 patients undergoing coronary artery disease stentingprocedures. These physicians will report on their initial experience with thedevice in multiple presentations at the Transcatheter CardiovascularTherapeutics (TCT) Conference to be held in Washington DC from October 12 to16, 2008. The TCT is the world's leading meeting for those performing coronarydiagnostics and stenting.
The system permits the performance of spectroscopy, which is widely usedto determine chemical composition of unknown materials, to be performed insidethe coronary artery of a living patient. Dr. Craig M Gardner, Director ofAlgorithm Development at InfraReDx and lead author of the validationmanuscript explained that: "NIR spectroscopy is sensitive to the chemicalcomposition of tissue, can penetrate through several millimeters of blood, andcan 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. Mullerat the TCT sponsored Vulnerable Plaque Symposium.
In addition to the general presentations, there will be the followingpresentations describing specific features of the LipiScan system:
-- Near-Infrared Spectroscopic Measurement of Lipid-Core Coronary PlaqueLength: Implications for Complete Lesion Coverage in Patients UndergoingStenting - Simon Dixon, Presentation on Monday, October 13 at 12:24PM in Room152A.
-- Relationship of the Near Infrared Lipid Core Burden Index in CoronarySegments with Traditional Risk Factors in Patients Undergoing PCI - JohnPeterson, Poster
-- Lipid rich plaque identified by near infrared spectroscopy isassociated with plaque shift in bifurcation lesions: An observation from theSPECTACL study - J. Goldstein, Case Study, Poster
-- Use of the Block Chemogram to Interpret the Near Infrared SpectroscopicSigns of Lipid Core Containing Coronary Plaques - C. Gardner, InfraReDx, Inc.TCT Poster
The LipiScan(TM) Coronary Imaging system will be displayed in thecompany's TCT 2008 booth (#1414 on level 2).
"The InfraReDx team is pleased that the LipiScan System has been validatedin tissue samples and a clinical study and has been cleared by the FDA for usein patients. We understand the great potential of interventional cardiologyand anticipate that this novel tool will assist physicians with the complexdecisions they face in the management of patients with coronary arterydisease," says James E. Muller, M.D., cardiologist, co-founder and CEO ofInfraReDx, Inc.
About InfraReDx Inc.
InfraReDx Inc. is a privately held medical device company located inBurlington, Massachusetts. InfraReDx is dedicated to improve patient carethrough development of its core optical technologies for the diagnosis andtreatment of cardiovascular disease.
About TCT 2008
Now in its 20th year the Transcatheter Cardiovascular Therapeuticssymposium, sponsored by the Cardiovascular Research Foundation, will takeplace at the Washington Convention Center in Washington, DC from SundayOctober 12 through Friday October 17, 2008.
Additional information can be found by visiting the InfraReDx website atwww.infraredx.com or by calling 1-888-680-REDX.Contact Denis Bonaccolta Tel: 781-221-0053 Ext 344 e-mail: [email protected]
SOURCE InfraReDx Inc.