vascuCAP Now Cleared for all ArteriesJanuary 25, 2019
vascuCAP® software is now cleared for clinical use in all arterial beds for US and European markets see https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183012.pdf. Extended labeling that describes the analytic performance was also cleared. Measurement performance not only for structural measurements of the vessel wall, lumen, stenosis and wall thickness but also tissue types comprising plaque composition measurements of lipid rich necrotic core, calcification, and plaque matrix are included.
These enhancements to vascuCAP’s indication and labeling expand support of clinical care decisions from carotid and peripheral vascular disease to the vital area of coronary artery disease. The labeling for plaque structure and component measurement performance is the first of its kind and represents a new benchmark in the industry.
The performance labeling captures vascuCAP®’s effectiveness at mitigating the calcium artifacts that have previously limited capabilities of earlier quantitative CT methods, now opening up the ability to not only better discriminate calcium from lumen but provide an unprecedented level of accuracy for what had been previously referred to as soft or low attenuation plaque for lack of objective validation, but may now properly be called lipid rich necrotic core (LRNC). This development is an important step towards the use of plaque composition in both determining optimal treatment across revascularization and intensive medical therapy, as well as assessing treatment effects for atherosclerosis patients longitudinally.
This clearance directly follows Elucid’s large and unique investment in histology validation methods. Now that the measurement performance is cleared across all arteries of significance to atherosclerosis, the next R&D priority will be to continue the drive in applying AI and deep learning methods leveraging validated plaque morphology to provide insights into each patient’s condition in terms of validated phenotypes optimizing the study and treatment of this most dangerous disease category.
Contact: Samantha St. Pierre firstname.lastname@example.org