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Non-Invasive Advanced Hemodynamic Monitoring

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VitalStream From Caretaker Medical - The New Standard in Wireless Patient Monitoring

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"In a medical emergency, every second and every beat are vital. The VitalStream saves precious time by eliminating wires, simplifying workflow and providing automatic measurement and reporting of key physiological parameters. The VitalStream Cloud enables physicians in the emergency room to remotely access real-time patient data and prepare the treatment plan while the patient is on the way to hospital. Streamline your workflow during admission and triage, stay mobile, and never miss a beat ("Vital Stream", 2022)."

https://caretakermedical.net/

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The Vital Stream is quick and easy to apply, and provides continuous advanced hemodynamic monitoring in a non-invasive manner. Vital stream consists of a comfortable finger sensor that picks up the arterial pulse pressure waveform. The encrypted data is then analyzed using the patented pulse decomposition algorithm (PDA) then sent wirelessly to a secure cloud or bluetooth device. Clinicians have the ability to monitor important vital signs minute by minute and patients have the freedom to move about without restrictions from leads or cables connecting them to a bedside monitor. I believe this device could be especially useful in a pandemic situation where triage and time are of the essence and patient conditions are rapidly changing. With limited resources including staff, Vital Stream could be the answer to help limit potentially risky invasive procedures that involve many resources and staff. Additionally, the Vital Stream could help to reduce the transmission of contagious pathogens by eliminating multiple re-useable wires.

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My Top Five Strengths and how they will help the team:

1. Relator - Caring, honest, and calm demeanor will help to build strong relationships within the team that help meet goals.

2. Empathy - Understanding of others by listening and empathizing will help create trustworthiness within the group.

3. Developer - Recognizing strengths in other team members with the ability to help encourage execution will keep the group in a forward motion towards success.

4. Positivity - Keeping a positive and optimistic attitude will help connect the team and allow for growth.

5. Arranger - Flexibility and ability to make changes when needed will help the group to execute to the fullest.

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William (Woo)- William's ability to influence and hype up the group by breaking the ice and forming connection will help bring the group together to evaluate Vital Stream.

Angelica (Analytical) - Angelica will be a great asset to the team with her ability to strategically analyze the Vital Stream monitoring device. She will be able to think about and share with examples all the ways the device will be useful and/or not useful in the facility.

Abraham (Arranger) - Abraham's flexible attitude and ability to organize and make changes when needed will help keep the evaluation team cohesive.

Pablo (Positivity) - Pablo's enthusiasm and upbeat attitude will influence the group to focus on the positives of potentially bringing new technology into the facility.

Faith (Futuristic) - Faith will be able to inspire the team to think about the potential the Vital Stream could bring and visions for the future care in the facility.

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With the current COVID pandemic filling Emergency Departments (ED) across the the United States (US), the Vital Stream device could be a solution to monitoring patients in real time while they are waiting for a hospital bed. Providers would be able to see trends and triage patients based on the real time data. Because the device is small and wireless, it would provide more comfort than the typical cords and leads used to monitor patients. For healthcare providers, the Vital Stream is quick to apply and easy to use, saving time and providing valuable data needed to best treat patients. I believe this is a device that could be used in all areas of the hospital as well as for first responders.

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FDA approved, non-invasive, wireless, monitoring device, that can be placed quickly on a patient to provide real time advanced hemodynamic monitoring. Beneficial to providers by helping them to triage patients quickly and appropriately with the ability to act at the first sign of decompensation. The vital stream can give data that typically would only be available from an invasive line such as an arterial line. Invasive lines such as arterial lines are inserted not without risk and require many resources as well as time. The Vital Stream provides safe, effective and risk free monitoring that can be used in a variety of patient settings.

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"Caretaker Medical® is a MedTech Innovator founded in Charlottesville, Virginia, in March 2014 to commercialize wearable monitoring devices constructed around our Patented Pulse Decomposition Analysis technology ("Vital Stream", 2022)."

Jeff Pompeo- President & CEO

Medical Advisory Board
Joseph L. Hutchison, M.D.
Dr. Chris Ghaemmaghami, M.D.
Jay H. Sanders, M.D.
Younghoon Kwon, M.D

FDA Approval August 13, 2021 - https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211588.pdf

https://caretakermedical.net/

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Website: Medgadget

Article: Wireless Blood Pressure and Hemodynamic Monitoring: Interview with Jeff Pompeo, CEO, Caretaker Medical

Author: Conn Hastings
Published: NOVEMBER 11TH, 2021

Website: https://www.medgadget.com/2021/11/wireless-blood-pressure-and-hemodynamic-monitoring-interview-with-jeff-pompeo-ceo-caretaker-medical.html

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Caretaker Medical, a company based in Virginia, developed the VitalStream wireless patient monitor, and the company recently announced that the device has received FDA clearance. The technology is intended to improve on traditional blood pressure cuffs that provide only a snap-shot of blood pressure data, while being an alternative, in many cases, over invasive arterial catheters that come with a variety of potential complications, including infections, and difficulties with insertion.

The VitalStream provides continuous, wireless monitoring of a variety of hemodynamic parameters and blood pressure, which is particularly important in patients at risk of dangerous hypotensive events. The device itself is worn on the wrist, and a disposable finger sensor delivers 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 rapid alerts of any abnormalities or dangerous events. Patients can wear the device while in a hospital, and then take it home for additional monitoring, if required. The data are streamed to an app, the cloud, or can be interfaced with hospital computer systems, and the system provides automated reporting.

See a video about the technology below.

Medgadget had the opportunity to speak with Jeff Pompeo, President and CEO at 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, Caretaker Medical: Your blood pressure is changing constantly - rising and falling as needed to circulate oxygenated blood to your organs - and it's greatly influenced by body movement, stress, heart rate changes and hemodynamic instability. Although long-term high blood pressure (hypertension) is associated with increased health risks, a far bigger concern is a sudden drop in blood pressure (hypotension), which can require immediate clinical intervention to avoid organ damage or even death. Studies show that up to 48 percent of non-cardiac surgery patients experience a dangerous hypotensive event 1-4 days after surgery, which is associated with a 183 percent increase in post-op 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, reliance on a typical "spot check" arm cuff blood pressure measurement provides only a single moment in time data point, leaving blind spots between intermittent readings where hemodynamic volatility is undetected. By contrast, continuous beat-by-beat blood pressure measurements eliminate blind spots and provide a real-time view of hypotensive decline so clinicians can make life-saving interventions immediately. Although frequent spot check blood pressure checks with typical arm cuffs are generally fine for healthy and stable patients, it's well-known that continuous BP monitoring for high-risk patients provides a far better picture of true hemodynamic health, and can help clinicians make better treatment decisions.
Medgadget: How is such monitoring conducted at present? How is this suboptimal?
Jeff Pompeo: The gold standard for continuous beat-by-beat blood pressure and hemodynamic monitoring is an invasive arterial catheter (a-line), which is inserted directly into a patient's artery and connected to a manually calibrated machine. But because of insertion difficulties, infection risks, and other challenges, a-lines are typically reserved for only the most critically ill patients under strict supervision in the ICU or OR. Therefore, the vast majority of patients are relegated to manual spot-check vital sign measurements taken every few hours, which of course means dynamic hemodynamic changes may go unnoticed and untreated for hours. Clinicians must therefore make decisions with incomplete and missing data. The COVID-19 pandemic has further stressed clinical staff and health system resources, making frequent manual vital sign checks even more challenging and increasing the risk that adverse events and errors may go unnoticed.

Medgadget: Please give us an overview of the VitalStream system and how it works.

Jeff Pompeo: VitalStream is a completely wireless, non-invasive, patient monitor that provides continuous beat-by-beat blood pressure, hemodynamic and vital signs monitoring, eliminating blind spots with uninterrupted real-time data without invasive a-lines. Using a disposable finger sensor and our Patented Decomposition Analysis (PDA™) technology, VitalStream measures continuous central aortic pressure and hemodynamics, but in a completely wireless platform to enable real-time and remote monitoring from anywhere. Continuous data and waveforms are streamed to our app or our remote secure cloud portal, or can be interfaced with EMRs and other platforms for automated reporting and streamlined workflow. VitalStream can be up and running on a patient in less than one minute and instantly alert clinicians to adverse hemodynamic events as they occur, even as patients move throughout the full continuum of care - even remotely after patient discharge. The VitalStream is FDA-cleared, and we have completed over a dozen clinical studies validating its accuracy. With VitalStream, patients are untethered from clunky cuffs, wires, and poles; clinicians enjoy automated workflow and continuous data for improved decision-making; and health systems can lower costs while improving care.
Medgadget: How does the VitalStream system measure continuous blood pressure, hemodynamics, and vital signs?
Jeff Pompeo: Our patented PDA™ Algorithms utilize a low-pressure finger sensor to analyze reflective waveforms in the aortic tree from each heartbeat. Our AI algorithms then derive changes in central aortic pressure to display waveforms and beat-by-beat values, as well as heart rate, respiration rate, and other parameters continuously. Using additional wireless sensors, VitalStream can also measure SpO2, ECG, body temperature, and ETCO2. All data is seamlessly displayed on our app, remote monitoring cloud portal, or integrated with EMRs and other monitors.
Medgadget: Congratulations on receiving FDA clearance for the system. Is the system already available to clinicians? If so, where is it currently being used?
Jeff Pompeo: Thank you. VitalStream is available for purchase now and more information is available on CaretakerMedical.net. We see a new paradigm where a VitalStream monitor stays with the patient on their journey across the full continuum of care, even going home after discharge, to create an uninterrupted digital record of personalized hemodynamic patient health - ultimately providing a path to predicting adverse events before they happen. Our current customers span a wide range of institutions and use-cases including critical care, trauma, perioperative settings, acute-care clinics, pharma clinical trials, infusion centers, sleep disorder labs, and remote patient monitoring. VitalStream checks every box of healthcare's quadruple aim by creating the opportunity for improved outcomes while being better for the patient, better for the clinician and better for the hospital.

Link: Caretaker Medical homepage...

Flashbacks: FDA Approves CareTaker® Wireless Remote Patient Monitor For Continuous Non-Invasive Blood Pressure ("cNIBP") and Heart Rate Monitoring using patented Finger Cuff Technology; Caretaker Beat-by-Beat Continuous Blood Pressure and Vital Signs Monitor Cleared in EU

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Wireless Blood Pressure and Hemodynamic Monitoring: Interview with Jeff Pompeo, CEO, Caretaker Medical

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Caretaker Medical, a company based in Virginia, developed the VitalStream wireless patient monitor, and the company recently announced that the device has received FDA clearance. The technology is intended to improve on traditional blood pressure cuffs that provide only a snap-shot of blood pressure data, while being an alternative, in many cases, over invasive arterial catheters that come with a variety of potential complications, including infections, and difficulties with insertion.

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Cons of the Vital Stream include motion artifact issues and the possibility that certain vasoactive medications could hinder reading (Kwon et al., 2021). More research is needed to determine accuracy of results when used in combination with vasopressors, intravenous antihypertensives, or in patients with significant pathology such as an aneurysm (Kwon et al., 2021).