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Called ARTSENS®, it is designed such that it can be used in routine medical examination by even non-experts, to assess and predict vascular health. It is powered by a proprietary non-imaging probe and an intelligent computing platform and is developed by the Healthcare Technology Innovation Centre (HTIC) at IIT Madras.
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The device has been assessed on more than 5,000 human subjects. The technology already has five utility patents in the U.S., European Union and India, 10 design patents and awaits awarding of 28 patents in various jurisdictions.
The product is ready for technology transfer and commercialization after extensive testing. The IIT Madras team intends to deploy this to conduct over a million vascular screenings per year.
The technology and field results of this device has already been published in over 100 scientific peer-reviewed publications. The latest research papers were published in the reputed, peer-reviewed Journal of Hypertension (doi: 10.1097/HJH.0000000000003181) and American Journal of Physiology-Heart and Circulatory Physiology (10.1152/ajpheart.00335.2022).
The research was led by Dr. Jayaraj Joseph, Assistant Professor, Department of Electrical Engineering, IIT Madras. The paper in the Journal of Hypertension was co-authored by Dr. P. M. Nabeel, Lead Research Scientist, HTIC-IIT Madras, Mr. V. Raj Kiran, PhD Scholar, Department of Electrical Engineering, IIT Madras, and Dr. Jayaraj Joseph.
Despite tremendous improvements in treatments and procedures, heart and blood vessel-related diseases continue to be the leading cause of death throughout the world. Early detection and timely intervention is the key.
Highlighting the unique features of ARTSENS®, Dr. Jayaraj Joseph, Assistant Professor, Department of Electrical Engineering, IIT Madras, said, "Reliable assessment of vascular health requires a measurement to be performed directly on the blood vessel walls and not on the skin surface. Our ARTSENS device can assess the effect of molecular and protein level changes in the vessel wall caused due to disease and ageing, by measuring the material property in a completely non-invasive and accurate manner."
Dr. Jayaraj Joseph added, "ARTSENS® makes vascular ageing assessment accessible to a large population in both clinical and also non-clinical settings such as in a gym and health centre, among others."
ARTSENS® has been approved for clinical studies in India, US, and Europe. An extensive clinical study is underway at AIIMS New Delhi. Scientists at Radboud University Medical Center, The Netherlands, are using this device to investigate the association between arterial age, physical (in)activity, and cardiovascular events and AIIMS New Delhi researchers are using it to study and understand the physiological underpinnings of arterial ageing in various disease conditions.
Highlighting the clinical utility of this device, Prof. Dick Thijssen, Radboud UMC, The Netherlands, who also collaborated on this project, said, "We have used the latest ARTSENS device in our recent clinical studies on more than 600 subjects. Easy to use, portable devices allow large scale research studies to truly understand vascular ageing. Ultimately, easy to use devices that evaluate vascular health have potential to improve clinical practice and for wide-spread adoption."
"Portable and easy to use devices such as ARTSENS, when indigenously developed and validated, offer a significant cost advantage and can be a game changer in large scale screening and can be used by any stakeholder interested in primary prevention strategies" says Dr. Mohanasankar Sivaprakasam, Faculty-in-Charge, HTIC, IIT Madras
"To the best of our knowledge, this is the first hand-held, easy-to-use, minimally operator-dependent, and cost-effective device that is suited for routine clinical practice and large-scale screening," said the scientists – Dr. P. M. Nabeel, V. Raj Kiran and Dr. Jayaraj Joseph – write in their recent paper in the Journal of Hypertension.
One of the main causes of cardiovascular diseases is the loss of flexibility and suppleness of the blood vessels of the body due to the cellular and molecular changes in the arterial wall, which is often followed deposition of plaque. When the artery becomes stiff and ages prematurely, the risks of cardiovascular events increase. Another marker of cardiovascular diseases is central blood pressure.
Another collaborator in ARTSENS®, Dr. Dinu S Chandran, Department of Physiology, AIIMS New Delhi, said, "The ability of ARTSENS to assess both local and arterial stiffness along with central blood pressure, all in a single test makes it extremely useful in estimating vascular health status as an early marker in multiple disease conditions."
Further, Dr. Dinu S Chandran added, "ARTSENS can open up the window of opportunity to non-invasively monitor the changes in vascular health much before the traditional cardiovascular risk factors are deranged in individuals at risk of developing cardiovascular diseases in the future. This will provide a significant quantum of 'lead time' to intervene and correct the life course trajectory of vascular health in comparison to the conventional cardiovascular screening approaches."
It must be remembered that central BP that is measured using a tonometer is a better predictor of heart health than peripheral BP that is commonly measured with the arm-cuff machine. Assessments of arterial stiffness and central BP are not part of routine clinical tests due to the absence of a convenient and reliable device to measure them, a drawback that the HTIC-IITM team has now overcome.
ARTSENS® simultaneously checks for arterial stiffness and central blood pressure. The device comprises pressure cuffs to be affixed at the upper arm and thighs and a probe applied to the surface of the neck to detect the carotid artery. It measures carotid arterial stiffness, aortic pulse wave velocity and central blood pressure, all three being important markers of cardiovascular health.
The IIT Madras team, not only performed basic scientific research but also engineering and tech development for clinically validated prototypes. Simulation studies and randomized experiments were conducted on animals and human subjects to prove efficacy and meet the standards required of biomedical diagnostic devices.
In their recent publication in Journal of Hypertension, the IIT Madras researchers have described the assessment of the usability, accuracy, and the intra-/inter-operator variabilities of the latest version of the device – ARTSENS® Plus.
They have conducted preclinical studies to verify the device's functionality under ARTERY Society guidelines. They have demonstrated the device's effortless and reliable evaluation of the local and regional vascular stiffness and central BP with an accuracy that meets the clinical standards. Multiple clinical studies using the device is underway both in India and Europe. More information about the ARTSENS device and the research at IIT Madras in vascular ageing may be found at http://artsens.tech
