AutoPress

Solve Blood Pressure Volatility

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AutoPress

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Perioperative Blood Pressure Control

  • Set Target Blood Pressure
  • Device Captures & Maintains Target
  • Simple, Compact, Portable, Practical
  • Patent Pending Technology
  • First to Market Solution
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The Problem

The current standard of care for perioperative blood pressure control often results in extreme spikes and dips in patient BP.  Research indicates that blood pressure volatility often results in microtissue damage and increases in morbidity and mortality.
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The Cause

Perioperative blood pressure control has remained relatively unchanged for decades. Clinicians use medication to control blood pressure with a ‘best guess’ dosage response to alarms and blood pressure extremes.  This manual process lacks strict vigilance and is susceptible to mistakes and distractions.
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The Solution

The AutoPress is a medical technology that will transform critical perioperative blood pressure control. The AutoPress regulates arterial blood pressure with an easy-to-use, low cost, solution that should decrease volatility thereby decreasing morbidity and mortality.
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Research & Clinical Studies

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Journal Anesthesia & Analgesia

Study: Anesthetic Management and One-Year Mortality After Noncardiac Surgery

Brief:
Intraoperative hypotension is a significant independent predictor of increased mortality. When systolic blood pressure falls below 80 mm Hg. for one minute, mortality increases at the rate of 3.6% per minute.

Heart

Study: Perioperative myocardial necrosis in patients at high cardiovascular risk undergoing elective non-cardiac surgery.

Conclusion: Age and intraoperative hypotension are independent predictors of perioperative myocardial damage.

Anesthesiology

Study: Relationship between Intraoperative Mean Arterial Pressure and Clinical Outcomes after Noncardiac Surgery Toward an Empirical Definition of Hypotension

Brief: Postoperative Acute Kidney Injury is associated with sustained intraoperative periods of mean arterial pressure less than 55 mm Hg

Journal of Cardiothoracic and Vascular Anesthesia

Study: High Post-Operative Blood Pressure following Cardiac Surgery Is Associated with Acute Kidney Injury and Death

Brief: Postoperative hypertension is associated with compromised outcomes as reflected by higher mortality, longer length of stay, and higher incidence of renal dysfunction.

Clinical Anesthesiology

Multicenter Study: Myocardial Injury Within Month of Surgery Is Third Leading Cause of Death

Conclusion: The threshold for injury seems to be an intraoperative mean arterial pressure less than about 65 mm Hg. The worse the hypotension, the worse the outcome.

Anesthesiology

Study: Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery

Conclusion: Mean arterial pressure below absolute thresholds of 65 mmHg or relative thresholds of 20% were progressively related to both myocardial and kidney injury.

Journal of the American Medical Association

Study: Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery - A Randomized Clinical Trial

Conclusion: In this randomized clinical trial involving 292 patients, an individualized management strategy of targeting a systolic blood pressure within 10% of the patient’s normal resting value, compared with standard practice, resulted in significantly lower rates of postoperative organ dysfunction.

Journal Anesthesia & Analgesia

Study: Development and Evaluation of a Risk-Adjusted Measure of Intraoperative Hypotension in Patients Having Nonemergent, Noncardiac Surgery

Conclusion: Intraoperative hypotension was common and was associated with acute kidney injury and in-hospital mortality. There were substantial variations in clinician-level scores, and the measure score distribution suggests that there may be opportunity to reduce hypotension which may improve patient safety and outcomes. 

Possible Clinical Applications

General Surgery

Head Trauma

Spinal Cord Injury

Stroke/CVA

Preeclampsia /PIH

Open Heart Surgery

Carotid Endarterectomy

Ortho/Spine Surgery

General Surgery

The Challenge – Cumulative Micro-tissue Damage:
Patient blood pressure volatility during general surgery can be unexpected and varied. Extremes of blood pressure even for short periods of time may result in increased morbidity and mortality.  

Evidence – Journal Anesthesia & Analgesia study by Monk, et al., “Anesthetic Management and One-Year Mortality After Noncardiac Surgery” concluded that when systolic blood pressure falls to below 80 mm Hg. for 1 minute, mortality increases by 3.6%. The damage appears to be cumulative.  A systolic pressure under 80 mm Hg. for 3 min results in an increased mortality over 10%.

Our Solution – Targeted Bi-Directional Blood Pressure Control:
The AutoPress is intended to reduce the occurrences of bi-directional blood pressure volatility during general surgery by responding to changes in the slope of BP and providing micro-doses of the appropriate medication required to return BP to the desired target level.

Head Trauma/Brain Surgery

The Challenge – Maintaining Delicate Cerebral Blood Flow:
Autoregulation of cerebral blood flow is impaired and becomes pressure passive with any injury to the brain.  It is critical to maintain stable blood pressure to preserve cerebral blood flow in the presence of neurological injury, tumor, trauma and surgery.

The Evidence – Journal of Neurosurgery study by E. C. Jünger, et al. “Cerebral autoregulation following minor head injury” indicates that a significant number of patients with minor head injury may have impaired cerebral autoregulation and may be at increased risk for secondary ischemic neuronal damage.

Our Solution – Precise Blood Pressure Control:
AutoPress operators can set a target blood pressure and thus help to maintain cerebral perfusion and help to compensate for poorly functioning or absent cerebral autoregulation in head-injured patients.

Stroke/CVA

The Challenge – Timely blood pressure management is essential for ischemic stroke patients: There is a demonstrated U-shaped relationship between blood pressure and death in stroke patients. Optimal initial systolic BP is in the range of 140 to 160 mm Hg.  Results support the need for higher BP immediately after stroke. 

The Evidence – Journal of the American Medical Association randomized controlled trial led by Jiang He,  et al. “Effects of immediate blood pressure reduction on death and major disability in patients with acute ischemic stroke: the CATIS randomized clinical trial.”

Our Solution – Rapid, Measured, Stable Blood Pressure Control: It is very difficult to control systolic blood pressure so accurately, in the study listed mortality increased with systolic pressures over 160 and below 140. The AutoPress is able to deliver precise vasoactive medications that can help perform this difficult task.

Spinal Cord Injury

The Challenge – Spinal cord injury guidelines recommend mean arterial pressures above 85 mm Hg:
There is a positive correlation between mean arterial pressure values and neurological recovery from traumatic spinal cord injury.  

Evidence – Journal of World Neurosurgery study by Joshua Stephen Catapano, MD, et al. “Higher Mean Arterial Pressure Values Correlate With Neurological Improvement in Patients With Initially Complete Spinal Cord Injuries.”

Our Solution – Targeted Mean Arterial Pressure:
The AutoPress precisely delivers vasopressor doses in response to decreases in mean arterial blood pressure in order to maintain spinal cord perfusion pressures.

Preeclampsia /PIH

The Challenge – Preeclampsia/eclampsia markedly elevates the risk for intracranial hemorrhage: A paradigm shift is needed toward aggressive antihypertensive therapy for this patient population. 

The Evidence – Journal of Obstetrics & Gynecology study by James N. Martin, Jr.,  et al. “Stroke and severe preeclampsia and eclampsia: a paradigm shift focusing on systolic blood pressure” concludes that the focus of treatment should be the urgent control of systolic blood pressure less than 150mm Hg.

Our Solution – Control of High Blood Pressure Extremes:The AutoPress monitors and reacts to keep systolic blood pressure below dangerous levels.

Open Heart Surgery

The Challenge – Hypotension and hypertension in cardiac surgery patients are associated with adverse clinical outcomes: Postoperative hypertension is strongly associated with adverse outcomes, including acute kidney injury as well as death, in patients following cardiac surgery. Hypotension is a frequent complication in the intensive care unit after adult cardiac surgery.

The Evidence – Journal of Cardiothoracic and Vascular Anesthesia study by Felix Balzer, MD, MSc, et al. “High Postoperative Blood Pressure After Cardiac Surgery Is Associated With Acute Kidney Injury and Death” concludes that tight hypertension control reduces serious adverse outcomes in cardiac surgery patients.  Also, World Journal of Critical Care Medicine found, “Hypotension after intensive care unit drop-off in adult cardiac surgery patients”

Our Solution – Perioperative Blood Pressure Control:
The AutoPress is transportable through the perioperative continuum of care where it can be used to control the frequent hypotensive and hypertensive episodes experienced by cardiac surgical patients.

Carotid Endarterectomy

The Challenge – Treatment of hemodynamic instability for patients after carotid endarterectomy: Significant postoperative hypotension is associated with increased perioperative mortality, cardiac, or stroke complications, as well as increased 1-year death or stroke following carotid endarterectomy.

The Evidence – Journal of Vascular Surgery study by Tze-Woei Tan, MD,  et al. “The need for treatment of hemodynamic instability following carotid endarterectomy is associated with increased perioperative and 1-year morbidity and mortality” 

Our Solution – Control of Blood Pressure Extremes: The AutoPress monitors and reacts and intervenes to minimize the potential for hypertension or hypotension.

Ortho/Spine Surgery

The Challenge – Perioperative myocardial damage in orthopedic surgery: Analysis shows that risk for elevation of troponin increased with orthopedic surgery or intraoperative hypotension; increasing duration of hypotension strongly predictive of myocardial necrosis.

The Evidence – Journal Heart study by Richard F. Alcock,  et al. “Perioperative myocardial necrosis in patients at high cardiovascular risk undergoing elective non-cardiac surgery.”

Our Solution – Targeted Blood Pressure Control: The AutoPress is intended to reduce the occurrence of blood pressure volatility risk associated with myocardial necrosis and troponin leak.

Potential Benefits

Benefit
AutoPress
Standard
Blood Pressure Volatility
Delays in Therapy
Accident Prone
Trial and Error Response Method
Strict Vigilance of Patient B.P.
Targeted B.P. Control
Immediate Response to B.P. Changes
Continuous B.P. Regulation
Calculated Drug Response
Precise Medication Microtitration
Ease of Use
Uniform Care Across Patient Populations
Reduced Cumulative Microtissue Damage
Data Capture
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Milestones

2014

Provisional Patent Application, pending docket #276US01PCT

2015

Proof of Concept Bench Prototype

2016 – 2024

Responsive Blood Pressure Controller Algorithm Development

2019

Institutional Review Boards (IRB) Study, Live Patient Data Controller Testing

2021

FDA Pre Sub Meeting

2022

Validation Animal Study

2024

Breakthrough Medical Device
FDA (CDRH) Breakthrough Device Designation Granted June 7, 2024.

Frequently Asked Questions

About Us

Automedicus Corporation, Inc. is a medical device firm that has invented, and is developing, a transformative blood pressure management device called AutoPress. AutoPress is a low-cost solution for a high-cost problem in a large market.
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Contact Us

P: (123) 456-7890
F: (123) 456-7890
E: info@automedicus.com
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