Transaction Description:
METHOD FOR RAPID NON-INVASIVE ASSESSMENT OF CORONARY STENOSIS - VCARDIO, INC METHOD FOR RAPID NON-INVASIVE ASSESSMENT OF CORONARY STENOSIS PROJECT SUMMARY WE HAVE DEVELOPED A NON-INVASIVE TECHNIQUE FOR QUANTIFYING THE SEVERITY OF STENOSIS (BLOCKAGE) IN CORONARY ARTERIES. ONE MILLION INVASIVE CORONARY ANGIOGRAPHY (ICA) PROCEDURES ARE PERFORMED EVERY YEAR IN PATIENTS WHO PRESENT WITH CHEST PAIN OR ARE KNOWN TO HAVE STABLE CORONARY ARTERY DISEASE (CAD). THE GOAL OF THE PROCEDURE IS TO DETERMINE IF THERE IS ANY SIGNIFICANT STENOSIS THAT LIMITS BLOOD FLOW TO THE HEART MUSCLE IN THE CORONARY ARTERIES. ALMOST HALF OF ICAS CULMINATE IN STENT PLACEMENT IN CORONARY ARTERIES IN ORDER TO RELIEVE THE BLOCKAGE OF BLOOD FLOW. THE CARDIOLOGIST PERFORMING THE PROCEDURE IN THE CATHETERIZATION LAB DETERMINES THE SIGNIFICANCE OF THE STENOSIS BY ONE OF TWO METHODS: EITHER BY VISUALLY ESTIMATING THE DEGREE OF STENOSIS (‘EYEBALLING’ THE STENOSIS), WHICH IS THE ROUTINE PRACTICE AND IS DONE IN THE MAJORITY OF PATIENTS, OR BY INVASIVELY MEASURING FRACTIONAL FLOW RESERVE (PRESSURE-WIRE FFR), WHICH IS THE GOLD STANDARD TEST. HOWEVER, PRESSURE- WIRE FFR IS ONLY PERFORMED IN 10-20% OF PATIENTS BECAUSE IT IS INVASIVE, EXPENSIVE, AND TIME- CONSUMING, AND REQUIRES MORE RADIATION AND CONTRAST EXPOSURE. THE PROPOSED TECHNOLOGY PROVIDES AN ACCURATE, HIGHLY SENSITIVE AND SPECIFIC, NON-INVASIVE METHOD TO ASSESS THE SIGNIFICANCE OF CORONARY STENOSIS THROUGH CORONARY ANGIOGRAPHY WITHOUT PRESSURE-WIRE FFR MEASUREMENT. WHEN PERFORMED IN REAL-TIME, UNDER 2 MINUTES, THIS ALLOWS THE CARDIOLOGIST TO MAKE AN INFORMED DECISION REGARDING STENT PLACEMENT. SUCH A METHOD WOULD DELIVER THE BENEFITS OF PRESSURE-WIRE FFR MEASUREMENT IN TERMS OF COST SAVINGS AND IMPROVEMENT IN PATIENT SYMPTOMS, WHILE AVOIDING DISADVANTAGES SUCH AS EXTRA COST FOR THE PROCEDURE AND TIME BURDEN. IT PERFORMS FAVORABLY COMPARED TO COMPETING TECHNOLOGY IN TERMS OF ACCURACY BUT IS SUPERIOR TO COMPETITION WITH REGARDS TO THE TIME REQUIRED TO RUN THE SOFTWARE. THIS ALLOWS US TO PROVIDE A TRULY REAL-TIME SOLUTION FOR QUANTIFICATION OF CORONARY STENOSIS. OUR APPROACH USES REDUCED ORDER MODELING METHODS TO MODEL CORONARY BLOOD FLOW ACROSS STENOTIC CORONARY LESIONS AND ASSESS THE DEGREE OF STENOSIS SEVERITY BY INCORPORATING RESIDENCE TIME OF BLOOD FLOW THROUGH THE STENOTIC SEGMENTS. THE MAJOR ADVANTAGE OF THIS APPROACH OVER THE COMPETING SOLUTIONS IS ITS POTENTIAL TO DELIVER A REAL-TIME VIRTUAL SOLUTION WITHIN SECONDS. ONCE IMPLEMENTED, THE SOLUTION WOULD MERGE SEAMLESSLY WITH THE CURRENT CATHETERIZATION LAB EQUIPMENT AND PROVIDE A REAL-TIME, OBJECTIVE TOOL FOR ASSESSMENT OF CORONARY LESIONS BY THE TREATING CARDIOLOGISTS. THE OBJECTIVE IS TO SCALE THE STUDY FROM AN INITIAL SUCCESSFUL 54 PATIENT STUDY UP TO 500 PATIENTS (400 PATIENTS IN DERIVATION COHORT AND 100 PATIENTS IN VALIDATION COHORT) BY CONDUCTING A RETROSPECTIVE STUDY IN PATIENTS WITH KNOWN CAD WHO HAVE UNDERGONE CORONARY ANGIOGRAPHY AND PRESSURE-WIRE FFR MEASUREMENT FOR CLINICAL INDICATIONS.
