Quantitative coronary analysis and TIMI evaluation

• Quantitative Coronary Analysis (QCA) is performed on the pre-implantation angiogram to determine the baseline mean vessel diameters and locate the target segment for implantation
• QCA is performed on the post-implantation and follow-up angiograms to calculate the following measurements as per Testing Facility’s software calculation
• Mean Vessel Diameter (Ideal Diameter) of the target segment of the artery (baseline or pre-implant) versus that of post-implantation and follow-up

Optical Coherence Tomography (OCT) is a light-based imaging modality permitting the in-vivo visualization of stent studies upto resolution of 15 microns for stent opposition, tissue coverage, vessel wall structural changes and characterisation of atherosclerosis- scierotic plaque components. MRIDA-Core Lab uses llumien OptisTM Software Version E4.1, used with Abbott's OPTISTM integrated system.

IVUS is a technique providing cross- sectional, high-resolution tomography images of the arterial wall. At MRIDA core labs we perform qualitative and quantitative assessment of arterial atheroscierotic plaque thickness, quantify luminal area of obstruction and quantitative assessment of incomplete stent apposition using POLARIS IVUS software in Boston Scientific IVUS Integrated System.

Clinical evaluation is the assessment and analysis of clinical data pertaining to a particular medical device to verify its clinical safety and performance. The clinical evaluation is based on comprehensive analysis of pre and post-market clinical data relevant to the intended use of the medical device. This includes data specific to the medical device as well as any data relating to medical devices claimed as equivalent by the manufacturer. The whole process is documented in a clinical evaluation report (CER).

Our In-House experienced medical writing department will assist the medical devices manufacturing companies with many aspects of the clinical evaluation process and CER preparation in-line with MEDDEV 2.7.1 Rev 04 and MDD / AIMED / MDR.

OUR EXPERTISE

• End-to-end Clinical Evaluation Report (CER) writing
• Identify, search, analyze the appropriate scientific literature applicable to the manufacturer
• Developing regulatory complaint CER template
• Develop standard operating procedure to compile PMS data to update CERs
• PMS / PMCF data support for existing devices in the market
• Gap analysis and periodic update of existing CER