CCTA

HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

Retrieved on: 
Tuesday, March 26, 2024

The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).

Key Points: 
  • The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).
  • The DECODE study showed that clinicians using the HeartFlow Plaque Analysis changed their management decisions for 66% of patients compared to CCTA alone across various patient presentations and disease stages.
  • “We believe real-world prospective data from the new DECIDE Registry will empower clinicians with enhanced patient insights leveraging HeartFlow Plaque Analysis to improve patient outcomes.
  • The primary endpoint for this registry will highlight change in medical management after HeartFlow Plaque Analysis compared to after CCTA alone.

American College of Cardiology Presentation Highlights Promising Results Showing Potential to Reduce Coronary Inflammation with Abcentra's Orticumab

Retrieved on: 
Monday, April 8, 2024

ATLANTA, April 8, 2024 /PRNewswire/ -- Abcentra LLC, a clinical-stage biopharmaceutical company specializing in coronary artery disease, presented the latest results from a Phase 2a pilot, placebo-controlled, randomized clinical trial of Orticumab, a new drug with a novel mechanism of action to combat coronary inflammation, at the American College of Cardiology (ACC) Annual Scientific Sessions in Atlanta. The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.

Key Points: 
  • The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.
  • Orticumab is a monoclonal antibody against oxidized low-density lipoprotein (oxLDL), a key driver of plaque inflammation and destabilization in coronary artery disease.
  • Abcentra partnered with Caristo Diagnostics to leverage its CaRi-Heart AI technology to measure changes in patients' coronary artery inflammation as result of therapeutic intervention.
  • The results from this trial indicate that targeting oxLDL with Orticumab may reduce residual inflammatory risk and improve outcomes for patients with cardiovascular disease.

American College of Cardiology Presentation Highlights Promising Results Showing Potential to Reduce Coronary Inflammation with Abcentra's Orticumab

Retrieved on: 
Monday, April 8, 2024

ATLANTA, April 8, 2024 /PRNewswire/ -- Abcentra LLC, a clinical-stage biopharmaceutical company specializing in coronary artery disease, presented the latest results from a Phase 2a pilot, placebo-controlled, randomized clinical trial of Orticumab, a new drug with a novel mechanism of action to combat coronary inflammation, at the American College of Cardiology (ACC) Annual Scientific Sessions in Atlanta. The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.

Key Points: 
  • The trial revealed that treatment with Orticumab during a 15-week period significantly reduced coronary inflammation in patients with psoriasis, who have a higher risk of adverse cardiac events, associated with elevated coronary artery inflammation.
  • Orticumab is a monoclonal antibody against oxidized low-density lipoprotein (oxLDL), a key driver of plaque inflammation and destabilization in coronary artery disease.
  • Abcentra partnered with Caristo Diagnostics to leverage its CaRi-Heart AI technology to measure changes in patients' coronary artery inflammation as result of therapeutic intervention.
  • The results from this trial indicate that targeting oxLDL with Orticumab may reduce residual inflammatory risk and improve outcomes for patients with cardiovascular disease.

Cleerly® ISCHEMIA™ Demonstrates Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials

Retrieved on: 
Thursday, March 28, 2024

The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.

Key Points: 
  • The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.
  • For patients with an abnormal Cleerly AI-QCT ISCHEMIA finding, a positive result was associated with an approximately 7-fold increase of adverse cardiovascular events during an 8-year follow-up.
  • Collectively, this study shows that Cleerly AI-QCT ISCHEMIA, when used in conjunction with Cleerly LABS, can provide a 3-in-1 approach for the assessment of atherosclerosis, stenosis and ischemia.
  • These study results come after Cleerly announced that its Cleerly ISCHEMIA software device is billable using the new Category I CPT® code 75580.

Heart & Lung Health selects Caristo Diagnostics AI technology to provide early diagnosis of coronary artery disease UK-wide

Retrieved on: 
Tuesday, March 19, 2024

OXFORD, England, March 19, 2024 /PRNewswire/ -- Heart & Lung Health (HLH), a UK-wide network of over 110 expert cardiothoracic radiologists, has partnered with Caristo Diagnostics, a leading cardiac disease diagnostics company, to offer the novel CaRi-Heart® AI technology to predict patients' risk of developing potentially fatal coronary artery disease.

Key Points: 
  • OXFORD, England, March 19, 2024 /PRNewswire/ -- Heart & Lung Health (HLH) , a UK-wide network of over 110 expert cardiothoracic radiologists, has partnered with Caristo Diagnostics , a leading cardiac disease diagnostics company, to offer the novel CaRi-Heart® AI technology to predict patients' risk of developing potentially fatal coronary artery disease.
  • Many will undergo a coronary computed tomography angiography (CCTA) scan to diagnose coronary artery disease caused by plaques that narrow or block the arteries that supply blood to the heart.
  • "Early diagnosis and interventions have the potential to significantly improve health outcomes for thousands of patients at risk of coronary artery disease.
  • We are pleased to announce our partnership with Heart & Lung Health, aiming to enhance accessibility to CaRi-Heart technology for patients throughout the UK," said Frank Cheng, CEO of Caristo Diagnostics.

Cleerly® ISCHEMIA™ Software Device Billable With AMA Category I CPT® Code for Noninvasive Estimates of Fractional Flow Reserve

Retrieved on: 
Thursday, February 22, 2024

The American Medical Association (AMA) defines this service as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR) to assist healthcare professionals in clinical diagnosis and decision making.

Key Points: 
  • The American Medical Association (AMA) defines this service as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR) to assist healthcare professionals in clinical diagnosis and decision making.
  • The Category I CPT® code is an addition to the Category III CPT® codes (CPT® 0623T, 0624T, 0625T, 0626T) used for reporting Cleerly’s advanced coronary atherosclerosis analysis.
  • “The Cleerly ISCHEMIA software provides noninvasive estimates of FFR values that help healthcare professionals make critical decisions in the management of patients with suspected coronary artery disease,” said James P. Earls, MD, Chief Medical Officer of Cleerly.
  • The application of Cleerly ISCHEMIA supports improvements in physician certainty, guides medical therapy decision making, and reduces unnecessary invasive and non-invasive testing2-6.

Cleerly® Announces CERTAIN Multicenter Clinical Trial Results

Retrieved on: 
Thursday, February 8, 2024

These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.

Key Points: 
  • These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.
  • In all multicenter and single clinical studies performed to date, Cleerly’s products have consistently demonstrated robust clinical utility, including higher diagnostic accuracy and stronger prognostic risk stratification over such historical tests as nuclear SPECT stress testing and FFRCT2-7.
  • Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials.
  • Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway.

Cleerly® Launches Cleerly® ISCHEMIA™ Solution for Heart Disease Analysis

Retrieved on: 
Tuesday, January 9, 2024

Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, intended as a diagnostic aid for patients undergoing coronary computed tomography angiography (CCTA) analysis using Cleerly Labs software.

Key Points: 
  • Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, intended as a diagnostic aid for patients undergoing coronary computed tomography angiography (CCTA) analysis using Cleerly Labs software.
  • When utilized by an interpreting healthcare provider, this software in conjunction with the results of Cleerly Labs provides personalized analysis that may be useful in detecting likely ischemia associated with coronary artery disease (CAD).
  • “Cleerly ISCHEMIA is a true testament to our unwavering commitment to scientific innovation and research-backed solutions,” Dr. Min said.
  • Cleerly ISCHEMIA is a transformative addition poised to reshape the landscape of cardiac care.”
    A Category 1 CPT code is available for the work performed in association with Cleerly ISCHEMIA analysis.

HeartFlow Achieves Landmark Milestone of 250,000 Patients Assessed for Coronary Artery Disease (CAD) with FFRCT Analysis

Retrieved on: 
Wednesday, January 3, 2024

MOUNTAIN VIEW, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary care solutions, today announced that it has surpassed 250,000 patients receiving a HeartFlow FFRCT Analysis.

Key Points: 
  • MOUNTAIN VIEW, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary care solutions, today announced that it has surpassed 250,000 patients receiving a HeartFlow FFRCT Analysis.
  • HeartFlow’s FFRCT provides clear insights into each patient’s condition with a patient-specific visual model of the heart’s blood flow.
  • Since its inception, HeartFlow has been committed to building a new standard of care for people at risk of heart disease.
  • “We've experienced a year of notable accomplishments and growth including the expansion of our product portfolio with Plaque Analysis and RoadMapTM Analysis.

Slow Down, Move Over, And Save Lives – Statewide Call to Action During Crash Responder Safety Week

Retrieved on: 
Monday, November 13, 2023

California’s Move Over law requires drivers to move over a lane down when approaching stopped emergency or maintenance vehicles with flashing amber lights.

Key Points: 
  • California’s Move Over law requires drivers to move over a lane down when approaching stopped emergency or maintenance vehicles with flashing amber lights.
  • Caltrans has partnered with the OTS and CHP to launch the “Move Over” campaign.
  • Traffic-related incidents are the leading cause of death for on-duty law enforcement officers, fire, EMS, maintenance workers, and tow/recovery professionals.
  • In 2021, more than 10,000 work-zone crashes occurred on California roadways, resulting in more than 4,500 injuries and 120 fatalities.