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CADScor®System: Overview

Use CADScor®System to Determine if Chest Pain is Related to the Heart*

CADScor®System is a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze the patient’s coronary blood flow. The system calculates a patient-specific CAD-score, and couples it with risk factors to rapidly indicate the patient’s risk of significant coronary stenosis for immediate risk stratification, prior to potential secondary evaluation.2 CADScor®System has been used in over 40,000 patient assessments 3 and has CE-marking and FDA De Novo clearance.

CADScor®System Uses Ultra-Sensitive Acoustics and Advanced Computational Processing to Rapidly Rule-Out Significant Coronary Artery Disease in 10 Minutes¹*

Non-invasive and radiation-free assessment for early rule-out of significant CAD.

Can help save costs of more advanced CAD diagnostics in up to 35% of patients.²

Rapid and easy-to-use, with clear results in 10 minutes.

An Individual CAD-score Indicates Low or Elevated Significant CAD Risk in Patients

The CAD-score is based on a phonocardiographic assessment, Advanced Computational Processing powered calculations and risk factors.¹

Low Risk

Significant CAD rule-out in 35% of patients². Seek alternative diagnosis for symptoms.

Elevated Risk

Significant CAD cannot be ruled out. Refer for further diagnostics.

CADScor®System Research, Development and Clinical Studies

CADScor®System is approved in Europe with CE-marking and has received FDA De Novo clearance as a diagnostic aid for symptomatic patients with suspected CAD. Multiple clinical studies have been published to demonstrate CADScor®System’s performance.

Physicians’ Experiences Using CADScor®System

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Schedule a Demo of CADScor®System

Schedule a free demo of CADScor®System and learn how you can rule out significant CAD patients in 10 minutes.*

  1. Winther S, et al. Heart 2018;104:928–935 (Dan-NICAD I)
  2. User manual US-FDA v.12.Y, prevalence 10,7%
  3. Based on commercial patch use since 2017

*Rule-out with at least 96% confidence (NPV)

Important Safety
Information

The intended use of the CADScor®System is to record heart sounds, i.e. murmurs and vibration for calculation of a patient specific score, the CAD-score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.

The CADScor®System is indicated for use as a diagnostic aid in symptomatic patients suspected of stable Coronary Artery Disease/Chronic Coronary Syndrome.

Symptoms of CAD/CCS may manifest as*
Typical angina symptoms;
(all three below)
• Sub-sternal chest discomfort of characteristic quality and duration
• Provoked by exertion or emotional stress;
• Relieved by rest and/or nitrates within minutes.

Atypical angina symptoms;
(Two of the above)

Non-anginal chest pain;
Lacks or meets only one or none of the above characteristics.

Dyspnea/breathlessness
*as defined by ESC Guidelines 2019 &NICE UK Guidelines CG95, 2019

Warnings are alerts described to alert and reduce the risk of death or serious injury from use of the CADScor®System.

Warnings and precautions are labelled with a warning triangle and also refers to the relevant section in the User Manual.

Do not use the CADScor®System without the necessary qualifications, and only after instruction and having read and understood this User-Manual, including, symbols, contra-indications, warnings and precautions, due to risk of death or serious injury.

Do not use the CADScor®System on patients with implanted electronics like ICD, Pacemakers, heart-pumps closer than 50 cm to similar active electronic support equipment, due to risk of equipment failure from CADScor®System electromagnetic RFID impulse.

Do not attempt to re-use a CADScor®Patch. The patch is single use only for hygienic reasons, to prevent possible cross contamination/infection between patients.

The CADScor®System and patches are MRI-unsafe and should not be operated or placed in a Magnetic Resonance Imaging (MRI-) room, due to risk of skin burns and/or magnetic attraction and impact.

Never use other power adaptor than supplied with the CADScor®System, due to risk of electrical shock.

Precautions are alerts to reduce potentially hazardous situations or risks of nonserious injury or reduced effectiveness from use of the CADScor®System.

Incorrect placement of the CADScor® Sensor, outside patient IC4-L, may result in an incorrect CAD-score.

Inform patients who have CAD-score ≤20 to seek medical attention if symptoms persist or worsen after initial evaluation”, due to the risk of a false negative CADScor result.

The CAD-scores from patients in the 30-39-year group are currently outside the intended patient population. A warning triangle indicates the higher uncertainty of their CAD-score.

Do not touch the charge-point terminals on the CADScor®System, due to risk of permanent damage to the electronics inside by electrostatic discharge.

Do not drop or exert excessive force to the CADScor®System since this may

damage the CADScor®System permanently.

Do not expose the CADScor®System to liquids (water, oils, detergents or similar) or dust, since this may damage the CADScor®System permanently.

The CADScor®System cannot be heator radiation sterilized, or machine washed/cleaned, since this may damage the CADScor®System permanently.

Do not modify the CADScor®System or use or repair a defect CADScor®System, due to risk of malfunctioning. The CADScor®System must only be serviced by qualified Acarix personnel.

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