UTHealth Receives FDA Approval for Coronary Flow Reserve Quantification Software
August 21, 2012 — The U.S. Food and Drug Administration (FDA) granted marketing approval for cfrQuant, coronary flow reserve (CFR) quantification software from the University of Texas Health Science Center at Houston (UTHealth). The software was developed under the guidance of K. Lance Gould, M.D., and the Weatherhead PET Imaging Center of the UTHealth Medical School, with contributions of software segments from Positron Corp.
Positron will distribute and support cfrQuant to its current and future U.S.-based cardiac PET (positron emission tomography) customers, under a licensing agreement with UTHealth. The cfrQuant software has been approved for use with 82Rb-chloride and 13N-ammonia. Gould has recused himself of receiving royalties in support of academic programs.
“The introduction of CFR, as a routine noninvasive measurement used in conjunction with cardiac PET imaging, provides a clear differentiator when compared to competing technologies; justifying the expansion of patient indication selection and approval for reimbursement,” said Joseph Oliverio, chief technology officer of Positron. “We believe cfrQuant will revolutionize the methodology of diagnosis and subsequent treatment of coronary disease, resulting in improved patient outcomes and cost savings within our heathcare system.”
“The capacity of noninvasive PET for quantitative myocardial perfusion using cfrQuant parallels the use of invasive, pressure-based fractional flow reserve (FFR) for assessing physiologic stenosis severity as a guide to management and revascularization procedures,” said Gould. “Sophisticated cardiac PET uniquely quantifies diffuse coronary artery disease (CAD) and/or the combination of diffuse and segmental disease that is not routinely feasible with other technologies.”
For more information: www.positron.com