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The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and other patient test results. including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has been clinically validated in males only. Use of the device in females has not been investigated. Certain patient conditions should be considered as a basis for excluding individual patients for testing based on a possible risk to them of the Valsalva maneuver, such as the following:. - Weight <88 pounds (40 kilograms)* 1. - Atrial flutter or atrial fibrillation with irregular ventricular response - Significant atrial or ventricular ectopy 3 - Hypertrophic obstructive cardiomyopathy 4. - History of paradoxical emboli 5. - Known intracardiac shunt 6. - Significant aortic valvular disease 7. - 8. Unstable angina - History of embolic CVA - 10. Myocardial infarction within one week of intended VeriCor testing - 11. Uncontrolled hypertension (systolic BP > 160mmHg or diastolic BP > 100mmHg) - 12. Hypotension (systolic BP<90mmHg) - 13. Symptomatic bradycardia - 14. Known cholesterol emboli - 15. Poor LV function with LV thrombus *Colin tonometer recommendation

The VeriCor device is intended to be used as one of several tools that will assist the cardiologist in assessment of the volume status of a patient, i.e., when the questions of either volume overload or volume depletion arises. A principal measure of intravascular volume status is the filling pressure in the left ventricle as best reflected by the left ventricular enddiastolic pressure (LVEDP). Measurement of the left ventricular enddiastolic pressure requires the placement of a catheter in the left ventricle of the heart to measure the pressures directly. This procedure involves a moderate risk to the patient but could result in arterial hemorrhage, stroke and death. Accordingly, it cannot be used as a routine procedure for patient assessment or for monitoring over time. An estimate of LVEDP may be obtained with somewhat less risk to the patient by catheterization of the pulmonary artery as described above. The resulting measurement, called the Pulmonary Capillary Wedge Pressure (PCWP), correlates well with LVEDP. PCWP is widely used as an alternative to direct measurement of LVEDP, even though it has potential for complications and limitations in accuracy that are recognized. The proposed device, the VeriCor, is intended to provide another point on the risk/benefit curve for assessment tools. The VeriCor is non-invasive, so it involves much less risk than catheterization of either the left ventricle or the pulmonary artery. The VeriCor device provides measurements that are well correlated with PCWP measurements. The Colin CBM7000 Pulse Tonometer and the W. E. Collins Airway Pressure Monitor each have an interface connection for a computer to read data from the devices. In the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure. The digital manometer is used to measure the airway strain of the patient blowing into the mouthpiece. The pulse tonometer provides an instantaneous and continuous measure of non-invasive blood pressure before, during and after the Valsalva manuever. Data are recorded from both devices so as to provide a baseline followed by a minimum of eight and a maximum of 15 seconds of modest expiratory strain which is followed by 15 to 20 seconds of post-strain recording. The computer controller acquires the data from the devices and provides a dialog with the health-professional user. The user coaches the patient to perform the necessary actions, and one or more practice sessions are used to ensure that the patient can perform those actions correctly.