Esaote’s PMI BV touts non-invasive FFR study
Esaote this week released results from a study of its Pie Medical Imaging BV subsidiary’s CAAS vFFR fractional flow reserve software designed to calculate pressure drops and the vFFR value in the coronary artery non-invasively, touting a high linear correlation to invasive FFR and high diagnostic accuracy.
The company’s CAAS vFFR uses two standard angiograms taken during standard catheterization procedures as input for a coronary physiology assessment, and provides a combination of functional and anatomical lesion assessment for supporting clinical decision making.
Results from the study indicated a strong linear correlation to invasively measured FFRs, which normally use pressure wires and hyperemic agents, and a high diagnostic accuracy in detecting FFR, the company said.
“In the FASTstudy. 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 ≤ 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,” principal study investigator Dr. Joost Daemen said in a press release.
“We are very proud of this technological and clinical achievement. which is the result of 30-year commitment and experience of our company in the field of cardiovascular analysis software and of the successful collaboration withthe most prestigious medical and scientific research centers,” PMI CEO René Guillaume said in a prepared statement.
The company’s CAAS vFFR solution has FDA 510(k) clearance, CE Mark approval in the European Union and is PMDA cleared in Japan.
