CardieX Limited, a global health technology company focused on cardiovascular disease, has filed a 510(k) premarket submission with the U.S. FDA for the CONNEQT Pulse, a dual blood pressure and arterial health monitor targeted at the home health, remote patient monitoring, and decentralized clinical trial markets.
Subject to final FDA-clearance, Pulse will incorporate a full suite of patented and trademarked heart and vascular health parameters beyond traditional blood pressure, enabling clinicians, patients, and consumers to gain more advanced insights into cardiovascular health. Pulse will also incorporate “over the air” (OTA) customizable display screens based on specific health parameters and disease conditions.
Pulse is built upon CardieX’s FDA-cleared SphygmoCor central blood pressure technology, developed by CardieX’s subsidiary, ATCOR.
SphygmoCor technology has been in use for over 20 years by researchers, specialist clinicians, and pharmaceutical companies looking to obtain advanced arterial health insights beyond traditional blood pressure.
SphygmoCor non-invasively measures what is known as “central aortic waveforms” and enables insight into multiple clinically relevant arterial health indicators – such as a patient’s arterial stiffness, central blood pressure (the blood pressure at your heart), pulse pressures, and key indicators of the vascular health of major organs (heart, brain, kidneys etc.). Measuring central blood pressure at the heart is considered to be superior to standard measurements of blood pressure at the arm mainly due to the proximity of the heart to the major organs.
SphygmoCor is currently used in over 4,000 clinical sites globally, over 250 current research projects by major medical research institutions, and 49 clinical trials to-date with the likes of Bayer, AstraZeneca, Andwin, GlaxoSmithKline (GSK), Novartis, and others. Currently, SphygmoCor is in use in the world’s largest study by Artery on the impact of COVID-19 on cardiovascular health, as well as existing clinical trials with Yale University, Andwin Scientific and Philip Morris.
The Pulse incorporates SphygmoCor central aortic waveform technology into a blood pressure monitor targeted at the home health, remote patient monitoring, and decentralized clinical trial markets.
Pulse will integrate with the CONNEQT Consumer App to provide medical-grade insights into a complete suite of FDA-cleared arterial diagnostics.
Remote Patient Monitoring
In addition, when connected to the CONNEQT Physician Portal, physicians will be able to remotely manage and monitor patients via a cloud-based, HIPAA-compliant, patient management portal – providing physicians with the ability to significantly enhance practice revenues and patient health outcomes.
Pulse will be unique in the remote patient monitoring market in multiple ways including:
- By providing a full suite of proprietary arterial health parameters for more advanced insights into a patient’s vascular health, beyond traditional blood pressure measurements;
- By enabling physicians to monitor multiple risk factors for hypertension and cardiovascular disease and other health disorders such as Alzheimer’s, kidney disease, preeclampsia, and stroke risk;
- By empowering physicians with new diagnostic insights into a patient’s overall vascular health including arterial stiffness, central blood pressures, and central pulse pressures, to name a few;
- By allowing physicians to bill for remote patient monitoring reimbursement at a level not available with traditional blood pressure monitors due to the unique, additional, CPT reimbursement code payable on the use of Pulse for central arterial waveform analysis;
- By being fully customizable – allowing physicians to remotely set up specific personalized arterial health parameters to monitor for each patient.
In addition, CardieX’s existing clinical trial partners will also be able to use the Pulse and Portal to remotely manage decentralized clinical trials.