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Development and commercial launch of the clinical tool of hemodynamics with non-invasive measurement of the systolic volume variation, integrated into the electrical impedance tomography

Grant number: 17/20223-5
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: August 01, 2018 - February 29, 2020
Field of knowledge:Engineering - Biomedical Engineering
Cooperation agreement: FINEP - PIPE/PAPPE Grant
Principal Investigator:Rafael Holzhacker
Grantee:Rafael Holzhacker
Company:Timpel S/A
City: São Paulo
Assoc. researchers: Luiz Henrique de Moura Teixeira Balloti ; Taciana Tonetto Castelo Branco Trigo

Abstract

The objective of the project is the development and commercial launch of the clinical tool of hemodynamics with a non-invasive measurement of systolic volume variation, approved by ANVISA and CE marked. The electrical impedance tomography performs measurements and has functionalities related to patient ventilation. The project aims to incorporate clinical tools (applications) and hemodynamic measures related to blood circulation in the lungs (variation of systolic volume, which is the volume of blood siphoned by the left ventricle). Volume replacement is a common practice in patients undergoing cardiac surgery; however, only 40% to 70% are able to respond positively to this practice, which aims to improve systolic volume and cardiac output. This wide range shows the gap between responders and non-responders, evidencing the need for predictive tools that can select patients who actually benefit from volume replacement, thus avoiding their ineffective or even harmful use. Early diagnosis of hypovolemia is extremely important in maintaining adequate cardiac output and avoiding organic dysfunction and increased perioperative morbidity and mortality. For this, it is necessary to measure the variation of the systolic volume of the patient. The noninvasive measure of systolic volume variation, as part of a clinical hemodynamic tool, will make the Electrical Impedance Tomography, currently manufactured and marketed by Timpel and used primarily by pulmonologists, be used by all physicians as well, for all patients who require hemodynamic monitoring. This will increase the potential market for the Tomography, as well as its frequency of use within an Intensive Care Unit. For each patient it is necessary to use a "disposable kit", in the business model similar to "Gillette". Without hemodynamic application, we predict an average of 5 times per month. This use must more than double when incorporating the hemodynamic function, bringing direct result by the sale of disposables. In addition to increasing the market potential and increasing its use, the commercial launch of the tool will also allow the sale of upgrades to the installed base of equipment, since the new tool will be fully compatible with the equipment already installed in the customers. The project is organized in the following main activities: 1. Incorporation to the equipment of the algorithm of measurement of variation of systolic volume; 2. Development of the user interface of the clinical tool; 3. Verification and improvements in algorithms; 4. Clinical study, comparing the performance of the measurement performed by the Electrical Impedance Tomography with two other methods; 5. Regulatory approval, involving the preparation of necessary documentation and approval by ANVISA and European certification body (CE); 6. Commercial launching in Brazil and Europe, with elaboration of promotional material, benefits and safety arguments when using the tomography vis a vis conventional methods. The clinical tool of hemodynamics with non-invasive measurement of systolic volume variation is also positive for patients, health care providers and payers, for the potential benefit and safety with the use of non-invasive technologies. (AU)