SBIR-STTR Award

Magnetic Resonance Imaging Subsystem for Cardiac Ischemia Evaluation
Award last edited on: 8/20/15

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$3,928,212
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Juan M Santos

Company Information

HeartVista Inc

998 Hamilton Avenue
Menlo Park, CA 94025
   (650) 948-2428
   N/A
   www.heartvista.com
Location: Single
Congr. District: 18
County: San Mateo

Phase I

Contract Number: 1R43HL084769-01A2
Start Date: 4/3/06    Completed: 3/31/12
Phase I year
2007
Phase I Amount
$132,355
Cardiac magnetic resonance imaging has been shown to be one of the best technologies for the evaluation of cardiovascular pathologies. The broad application of this promising technology is expected to significantly improve the treatment of patients with heart disease in general and ischemic heart diseases in particular. However, widespread adoption of this beneficial technology has been held back by the lack of both software infrastructure and specific software sequences that take advantage of this infrastructure to provide a complete ischemic examination that can be performed rapidly in the clinical environment. The aim of this application is to develop a commercial robust cardio- vascular subsystem that will enable the broad application of this technology to the clinical realm. Specifically, during Phase I of this proposal, HeartVista will develop and test a cardiovascular software infrastructure that provides an integrated environment for rapid cardiovascular imaging. This package will include real-time evaluation of myocardial function under stress conditions, volumetric perfusion imaging, high-resolution examination of myocardial viability in real-time and high-resolution examination of the proximal coronary anatomy. We further expect to collect 40 patient examinations for feedback and analysis in anticipation of full productization. Under previous NIH grant support through Stanford University, we have established real-time rapid imaging sequences for the assessment of wall motion and perfusion. We have also established the utility and accuracy of rapid coronary imaging sequences for the assessment of proximal coronary anatomy. Our goal in this proposal is to integrate these methods into a robust ischemic heart disease system to realize the clinical potential of cardiac MRI in the evaluation of coronary artery disease. Generally, our methods concern obtaining adequate temporal and resolution, spatial coverage, and contrast production for stress imaging using customized pulse sequences hardware to reduce data acquisition time, developing pulse a underlying real-time imaging platform that allows the seamless real-time integration of receiver coil functions, sequences, and post-processing and display that optimizes the workflow for studying patients with ischemia. This proposal focuses on developing and validating this combined examination to provide the clinician a robust and intuitive complete ischemic evaluation package that can be performed comfortably in less than 1 hour.

Thesaurus Terms:
computer program /software, coronary disorder, diagnosis, ischemia, magnetic resonance imaging arrhythmia, cardiovascular imaging /visualization, image enhancement, image processing, method development clinical research, human subject, time resolved data

Phase II

Contract Number: 2R44HL084769-02
Start Date: 4/3/06    Completed: 3/31/12
Phase II year
2010
(last award dollars: 2015)
Phase II Amount
$3,795,857

Cardiac magnetic resonance imaging has been shown to be one of the best technologies for the evaluation of cardiovascular pathologies. The broad application of this promising technology is expected to significantly improve the treatment of patients with heart disease in general and ischemic heart diseases in particular. However, widespread adoption of this beneficial technology has been held back by the lack of both software infrastructure and specific soft- ware sequences that take advantage of this infrastructure to provide a complete ischemic examination that can be performed rapidly in the clinical environment. The aim of this application is to develop a commercial robust cardiovascular subsystem that will enable the broad application of this technology to the clinical realm. Under previous NIH grant support through Stanford University, we have established real-time rapid imaging sequences for the assessment of wall motion and perfusion. We have also established the utility and accuracy of rapid coronary imaging sequences for the assessment of proximal coronary anatomy. Our goal in this proposal is to integrate these methods into a robust ischemic heart disease system to realize the clinical potential of cardiac MRI in the evaluation of coronary artery disease. During Phase I of this proposal, HeartVista developed and tested the alpha version of the cardiovascular software infrastructure that provides an integrated environment for rapid cardiovascular imaging. This package includes real-time evaluation of myocardial function under stress conditions, volumetric perfusion imaging, high resolution examination of myocardial viability in real-time and high-resolution examination of the proximal coronary anatomy. We installed the system at selected alpha sites and collected patient data. Generally, our methods concern obtaining adequate temporal resolution, spatial coverage, and contrast production for stress imaging using customized pulse sequences and hardware to reduce data acquisition time, 7 developing a underlying real-time imaging platform that allows the seamless real-time integration of receiver coil functions, pulse sequences, and post-processing and display that optimizes the workflow for studying patients with ischemia. This proposal focuses on developing and validating this combined examination to provide the clinician a robust and intuitive complete ischemic evaluation package that can be performed comfortably in less than 1 hour. During Phase II of this proposal, we will continue the development of our product based on the feedback obtained during Phase I and we will conduct a clinical study to demonstrate the non-inferiority of our product compared with conventional cardiovascular MRI examinations in robustness and diagnostic accuracy.

Public Health Relevance:
Ischemic heart disease remains the number one cause of mortality in the United States. Current diagnostic techniques have significant shortcomings that can result in inaccurate diagnoses. The reduced accuracy leads to a large number of unnecessary procedures. Given the enormous number of these procedures, even a modest improvement in diagnostic accuracy will have a large public-health impact. Cardiac magnetic resonance imaging has been shown to be one of the best technologies for the evaluation of cardiovascular pathologies. It is the only imaging modality that could provide all of the important parameters of ischemia evaluation in function, perfusion, viability and coronary anatomy in a single examination. The broad application of this promising technology is expected to significantly improve the treatment of patients with heart disease in general and ischemic heart diseases in particular. However, the adoption of this beneficial technology has been held back by the lack of both a software infrastructure and specific software sequences that take advantage of this infrastructure to provide a complete ischemic examination that can be performed rapidly in the clinical environment. The aim of this application is to develop a robust commercial cardiovascular subsystem that will enable the broad clinical application of this technology.

Thesaurus Terms:
Accuracy Of Diagnosis; Adoption; Anatomic; Anatomical Sciences; Anatomy; Back; Cardiac; Cardiac Diseases; Cardiac Disorders; Cardiovascular; Cardiovascular Body System; Cardiovascular Pathology; Cardiovascular System; Cardiovascular System (All Sites); Clinical; Clinical Research; Clinical Study; Communities; Computer Programs; Computer Software; Coronary; Coronary Arteriosclerosis; Coronary Artery Disease; Coronary Artery Disorder; Coronary Atherosclerosis; Data; Development; Diagnosis; Diagnostic; Diagnostic Method; Diagnostic Procedure; Diagnostic Technique; Dorsum; Environment; Evaluation; Feedback; Goals; Grant; Heart Diseases; Hour; Image; Imaging Technology; Individual; Infrastructure; Ischemia; Ischemic Heart; Ischemic Heart Disease; Ischemic Myocardium; Mr Imaging; Mr Tomography; Mri; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Measures; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Methods; Mortality; Mortality Vital Statistics; Motion; Myocardial; Myocardial Ischemia; Nih; Nmr Imaging; Nmr Tomography; National Institutes Of Health; National Institutes Of Health (U.S.); Nuclear Magnetic Resonance Imaging; Organ System, Cardiovascular; Pathology; Patients; Perfusion; Phase; Physiologic Pulse; Procedures; Process; Production; Public Health; Pulse; Research Infrastructure; Resolution; Sales; Science Of Anatomy; Site; Software; Stress; System; System, Loinc Axis 4; Technology; Testing; Time; Translations; United States; United States National Institutes Of Health; Universities; Unnecessary Procedures; Vascular, Heart; Zeugmatography; Anatomy; Base; Cardiovascular Imaging; Circulatory System; Clinical Applicability; Clinical Application; Clinical Care; Computer Program/Software; Data Acquisition; Design; Designing; Diagnostic Accuracy; Flexibility; Heart Disorder; Heart Ischemia; Imaging; Imaging Modality; Improved; Myocardial Ischemia/Hypoxia; Myocardium Ischemia; Novel; Public Health Medicine (Field); Public Health Relevance