Technology | Angiography | May 22, 2018

FAST Study Demonstrates High Diagnostic Accuracy of CAAS vFFR

Software for non-invasively assessing vessel fractional flow reserve achieves FDA 510(k) market clearance

FAST Study Demonstrates High Diagnostic Accuracy of CAAS vFFR

May 22 2018 — Pie Medical Imaging announced that clinical data on its CAAS vFFR (Cardiovascular Angiographic Analysis Systems for vessel Fractional Flow Reserve) software will be presented during EuroPCR 2018, May 22-25 in Paris, France. This software, which has received U.S. Food and Drug Administration (FDA) 510(k) clearance, can calculate the pressure drop and vFFR value in the coronary artery non-invasively, which means there is no need for a pressure wire and hyperemic agent.

FFR is an established technique used in interventional cardiology to measure pressure differences across a coronary stenosis. Based on this, cardiologists may take a decision on whether a coronary stenosis has to be treated with angioplasty or not. This examination is done during a catheterization procedure with the support of costly pressure wires and hyperemic agents.

CAAS vFFR allows clinicians to use two standard angiograms taken during a catheterization procedure as input to get access to coronary physiology assessment. For percutaneous coronary interventions (PCI), within one easy workflow, CAAS vFFR offers a combination of functional and anatomical lesion assessment (such as percentage stenosis) to support the interventional cardiologist in the clinical decision making process.

The FAST study — led by Ken Masdjedi, M.D., and Joost Daemen M.D., Ph.D., from Erasmus Medical Center, Rotterdam, the Netherlands — shows that vFFR as calculated using CAAS vFFR has a high linear correlation to invasively measured FFR.

"In the FAST study, we demonstrated that vFFR as calculated using CAAS vFFR has a high linear correlation to invasively measured FFR and high diagnostic accuracy to detect FFR less than or equal to 0.80. vFFR is a promising, fast and easy to use tool to assess coronary physiology without the need for a costly pressure wire or hyperemic agent,” said Daemen, principal investigator.

CAAS vFFR is CE marked in Europe and PMDA-cleared in Japan.

For more information: www.piemedicalimaging.com

 

Related Content

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve).

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve). Photo by Greg Freiherr

Feature | Cardiac Imaging | March 22, 2019 | By Greg Freiherr
Reflecting a trend toward the increased use of...
HeartFlow Analysis Successfully Stratifies Heart Disease Patients at One Year
News | CT Angiography (CTA) | March 19, 2019
Late-breaking results confirm the HeartFlow FFRct (fractional flow reserve computed tomography) Analysis enables...
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.

SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram. Results from an international study presented at #ACC19 show that pressure readings in coronary arteries may identify locations of stenoses remaining after cardiac cath interventions.

Feature | Cardiac Imaging | March 18, 2019 | By Greg Freiherr
As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the
Jennifer N. A. Silva, M.D., a pediatric cardiologist at Washington University School of Medicine in Saint Louis, Mo., describes “mixed reality” at ACC19 Future Hub.

Jennifer N. A. Silva, M.D., a pediatric cardiologist at Washington University School of Medicine in Saint Louis, Mo., describes “mixed reality” at ACC19 Future Hub.

Feature | Cardiac Imaging | March 17, 2019 | By Greg Freiherr
Virtual reality (VR) and its less immersive kin, augmented reality (AR), are gaining traction in some medical applica
WVU cardiology chief Partho Sengupta, M.D., describes at ACC 2019 how artificial intelligence already helps cardiologists in echocardiography.

WVU cardiology chief Partho Sengupta, M.D., describes at ACC 2019 how artificial intelligence already helps cardiologists in echocardiography. Photo by Greg Freiherr

Feature | Cardiac Imaging | March 16, 2019 | By Greg Freiherr
Machine learning is already having an enormous impact on cardiology, automatically calculating measurements in echoca
Bay Labs Announces New Data on EchoGPS, AutoEF AI Software at ACC.19
News | Cardiovascular Ultrasound | March 15, 2019
Artificial intelligence (AI) company Bay Labs announced the presentation of two studies assessing performance of the...
Podcast | Cardiac Imaging | March 15, 2019
Debate About Coronary Testing Highlights ACC Session
Siemens Healthineers Debuts Cardiovascular Edition of Somatom go.Top CT
News | Computed Tomography (CT) | March 14, 2019
Siemens Healthineers will introduce the Somatom go.Top Cardiovascular Edition, a new version of its established...