Medical concierge, a Virginia-based company, developed the VitalStream wireless patient monitor, and the company recently announced that the device has received FDA approval. The technology is designed to improve traditional blood pressure cuffs that only provide a snapshot of blood pressure data, while being an alternative, in many cases, to invasive arterial catheters that carry a variety of potential complications, including infections and difficulties. with insertion.
VitalStream provides continuous, wireless monitoring of a variety of hemodynamic parameters and blood pressure, which is especially important in patients at risk for dangerous hypotensive events. The device itself is worn on the wrist and a disposable finger sensor provides blood pressure readings and additional sensors measure ECG, SpO2, body temperature and ETCO2.
Caretaker Medical reports that the system can be set up quickly and provides quick alerts for any anomalies or dangerous events. Patients can carry the device while they are in the hospital and then take it home for additional follow-up, if needed. The data is transmitted to an application, to the cloud, or can be connected to the hospital’s computer systems, and the system provides automated reporting.
Watch a video on the technology below.
Medgadget had the opportunity to speak with Jeff Pompeo, President and CEO of Caretaker Medical, about the technology.
Conn Hastings, Medgadget: Please give us an overview of the health impacts of high or low blood pressure.
Jeff Pompeo, medical caregiver: Your blood pressure changes constantly, rising and falling as needed to circulate oxygenated blood to your organs, and is heavily influenced by body movement, stress, changes in heart rate, and hemodynamic instability. Although long-term high blood pressure (hypertension) is associated with increased health risks, a much larger concern is a sudden drop in blood pressure (hypotension), which may require immediate clinical intervention. to prevent organ damage or even death. Studies show that up to 48 percent of patients with non-cardiac surgery experience a dangerous hypotensive event 1 to 4 days after surgery, which is associated with an 183 percent increase in postoperative myocardial injury and death. .
Medgadget: Please give us a quick summary of blood pressure monitoring and its importance.
Jeff Pompeo: Because blood pressure changes constantly, confidence in a typical arm-to-arm blood pressure measurement provides only a moment in the temporal data point, leaving blind spots between intermittent readings where hemodynamic volatility is not detected. In contrast, continuous rate-by-rate blood pressure measurements eliminate blind spots and provide real-time insight into the decline in hypotension so that physicians can perform life-saving interventions immediately. Although frequent blood pressure checks with typical arm cuffs are generally correct for healthy, stable patients, it is well known that continuous monitoring of BP for high-risk patients provides a much better picture than true hemodynamic health and can help doctors do better treatment. decisions.
Medgadget: How is this tracked currently? How is this suboptimal?
Jeff Pompeo: The gold standard for continuous rate-by-rhythm blood pressure monitoring and hemodynamic control is an invasive arterial catheter (a-line), which is inserted directly into a patient’s artery and connected to a manually calibrated machine. But due to insertion difficulties, infection risks, and other challenges, A-lines are usually reserved only for the most critical patients under strict supervision in the ICU or operating room. Therefore, the vast majority of patients are relegated to manual measurements of vital signs of point control performed every few hours, which means, of course, that dynamic hemodynamic changes can go unnoticed and untreated for hours. Therefore, physicians must make decisions with incomplete and missing data. The COVID-19 pandemic has further stressed clinical staff and healthcare system resources, making frequent manual reviews of vital signs even more difficult and increasing the risk of adverse events and errors going unnoticed.
Medgadget: Give us an overview of the VitalStream system and how it works.
Jeff Pompeo: VitalStream is a completely wireless and non-invasive patient monitor that provides continuous monitoring of blood pressure, hemodynamics and vital signs rhythm by rhythm, eliminating blind spots with uninterrupted real-time data without invasive lines. Using a disposable finger sensor and our patented decomposition analysis (PDA ™) technology, VitalStream measures central aortic pressure and continuous hemodynamics, but on a completely wireless platform to allow remote control and in real time from anywhere. Continuous data and waveforms are transmitted to our application or our remote secure cloud portal, or can be connected to EMR and other platforms for automated reporting and streamlined workflow. VitalStream can be in operation in a patient in less than a minute and instantly alert doctors of adverse hemodynamic events as they occur, even when patients move throughout the continuum of care, even from remotely after patient discharge. VitalStream is FDA approved and we have conducted more than a dozen clinical studies that validate its accuracy. With VitalStream, patients have no clumsy cuff, cord, and stick ties; physicians enjoy an automated workflow and continuous data to improve decision making; and health systems can reduce costs while improving care.
Medgadget: How does the VitalStream system measure continuous blood pressure, hemodynamics, and vital signs?
Jeff Pompeo: Our patented PDA ™ algorithms use a low-pressure finger sensor to analyze reflective waveforms in the aortic shaft from each heartbeat. Our AI algorithms obtain changes in central aortic pressure to display waveforms and rhythm-by-rhythm values, as well as heart rate, respiratory rate, and other parameters continuously. With additional wireless sensors, VitalStream can also measure SpO2, ECG, body temperature and ETCO2. All data is displayed seamlessly in our application, on the remote monitoring cloud portal, or integrated with EMRs and other monitors.
Medgadget: Congratulations on receiving FDA approval for the system. Is the system already available to doctors? If so, where is it currently used?
Jeff Pompeo: Thanks. VitalStream is available for purchase now and more information is available CaretakerMedical.net. We see a new paradigm in which a VitalStream monitor stays with the patient on their journey through the continuous continuum of care, even returning home after discharge, to create an uninterrupted digital record of hemodynamic health personalized treatment of the patient, ultimately providing a way to predict adverse events earlier. passen. Our current clients cover a wide range of institutions and use cases that include critical care, trauma, perioperative environments, acute care clinics, pharmaceutical clinical trials, infusion centers, sleep disorders laboratories, and remote monitoring. patient. VitalStream checks every box of the quadruple healthcare goal creating the opportunity to improve outcomes while being better for the patient, better for the doctor, and better for the hospital.
Flashbacks: FDA Approves CareTaker® Wireless Remote Patient Monitor for Noninvasive Continuous Blood Pressure (“cNIBP”) and Heart Rate Control Using Patented Fingerprint Technology; Continuous blood pressure monitor and vital signs of caregiver rhythmically removed in the EU