Small Device,
Big Impact
Scalable, Non-Invasive Tissue Oximetry Monitoring
Never Miss a Moment
Traditional NIRS-based oximeters are often limited to use in critical patients in ICUs, cath labs, and the OR. Envello Core, initially designed for the American warfighter, is engineered to offer non-invasive continuous tissue oximetry monitoring in a miniaturized, scalable and wireless device for patients across any clinical settings – ranging from the ER to the ICU, to the home and beyond. The ability to perform continuous, real-time tissue oxygen monitoring and identify tissue perfusion trends may help detect declining health earlier, including reduced cardiovascular performance, and lead to earlier treatment and disease management.
These statements have not been evaluated by the U.S. Food and Drug Administration (FDA).
Revolutionary Power and Life-Changing Insights in Less Than 2 Inches
Traditional monitoring devices for cardiovascular health are bulky, complex, invasive, and often require extensive training. Envello is poised to revolutionize the field, with several significant advantages:
Width: 35mm
Height: 13mm
Weight: 41g
- Bluetooth
- Cloud-enabled
- Adhesive applied
- Rechargeable
- IP67 waterproof
- Reusable
Tissue Oximetry is Complimentary to Pulse Oximetry
Not all optical technologies are created equal. Although pulse oximetry (SpO2), a common vital sign, plays an important role in detecting how well lungs are oxygenating blood it provides limited to no information on tissue delivery.
In an induced limb ischemia experiment, we can see that blood oxygen concentration remains consistent as tissue oxygen (StO2) concentration declines. When the occlusion or blockage of the blood vessel is released, tissue oxygenation recovers. A similar effect may be seen in patients with hypovolemic shock, reduced cardiac output, arterial occlusions, and other cardiovascular conditions.
These statements have not been evaluated by the FDA.
Near Infrared Spectroscopy (NIRS)
Uses infrared light to measure continuous optical absorption of oxygen from hemoglobin (oxygen-carrying protein in red blood cells) in capillary, arterial, and venous blood in the area under the sensor.
NIRS may be used to measure:
- Continuous oxy vs deoxy hemoglobin
- Somatic tissue oxygenation (StO2) trends
- Muscle
- Bone
- Cerebral oxygenation (Sc02) trends
Photoplethysmography (PPG)
Uses infrared light to measure alternating absorption changes in arterial blood only.
PPG may be used to measure:
- Arterial blood oxygen saturation (SpO2)
- Pulse rate (PR)
- Respiratory rate (RR)
Envello Core is designed to provide both NIRS and PPG measurements continuously with a single compact sensor.
These statements have not been evaluated by the U.S. Food and Drug Administration (FDA)
IRB-Approved Clinical Research
Validation of Argus Oximetry System to Measure Cerebral, Somatic, and Peripheral Tissue Oxygen Saturation and Pulse Rate in Healthy Volunteers
Objectives:
- Conduct clinical validation study for potential FDA submission of Envello Core (formerly called Argus), designed to measure tissue oximetry, pulse oximetry, and pulse rate
- Assess diverse skin tone population to demonstrate equal robustness including during motion and low perfusion / ischemic states
Clinical Evaluation of NIRSense Total Oximetry Monitoring of Cardiopulmonary Function
Objectives:
- Demonstrate perfusion changes in heart failure patients using easy-to-implement clinical tests
- Use perfusion changes alone to differentiate between New York Heart Association heart failure categories
Feasibility Study of the NIRSense Sensor Devices for Monitoring Blood Oximetry in Patients with an Implanted Impella Perfusion Pump
Objectives:
- Evaluate clinical feasibility of implementing continuous tissue perfusion monitoring in an ICU setting
- Evaluate perfusion changes in patients with mechanical circulatory support made by J&J’s Abiomed
Feasibility Study of the NIRSense Sensor Patch to Monitor Cardiogenic Shock
Objectives:
- Expand clinical feasibility evaluation for implementation in high volume ICU
- Collect a large volume of patient data comparing microvascular perfusion with tissue oximetry from NIRS with sublingual perfusion with videography
Collaborating with Leading Research Partners
We have key partnerships with several of the industry’s leading researchers and institutions to ensure we are building clinically effective, safe, and affordable solutions.
Interested in Research, Collaboration, or Investment?
As Envello enters a phase of rapid growth, we are interested in strategic partners who share our vision and goals to help expand our reach and bring our groundbreaking monitoring solutions to patients worldwide. If you are interested in collaborating, please fill out the below form and our team will get in touch with you soon.