To better support engineering teams with regulatory submission, BDC Laboratories recently introduced Statys® GOA, an equipment-agnostic software program that automates and simplifies geometric orifice area (GOA) analysis in prosthetic heart valves.
Statys® GOA is the first purpose-built software for engineers looking for a quantitative comparison of heart valve leaflet opening area between hydrodynamic testing and accelerated wear testing. It’s designed to help engineering teams better comply with ISO 5840, which focuses on heart valve substitutes, and related accessories, designed for implantation. ISO 5840 outlines an approach for design validation that champions risk management to improve clinical outcomes.
Addressing GOA Analysis Challenges with Software Support
GOA analysis presents a multi-dimensional imaging challenge because heart valves aren’t common, standard shapes. Prosthetics are designed with complex geometries and perform articulated movements to mimic the action of the original valve(s).
To manage the complexity of these prosthetic forms and improve the fidelity of test results, Statys® GOA is designed with multiple algorithms that automatically correct image quality ahead of video and still image analysis. These algorithms make it easy to fix less-than-ideal lighting conditions and improve contrast for clear differentiation between leaflet edges and backgrounds. Without contrast, it’s difficult to collect accurate measurements using edge detection. Once images are prepared, Statys® GOA overlays boundaries to determine the GOA of each frame.
Today, it’s common for engineering teams to create their own GOA analysis algorithms in general-purpose software platforms. With Statys® GOA, you can leverage BDC Laboratories’ decades of experience in medical device testing for efficient and insightful GOA analysis.
Statys® GOA adds to our growing suite of medical device testing services and products to aid in the mechanical and functional evaluation of medical device technologies. BDC Laboratories offers comprehensive ISO/IEC 17025:2017 accredited testing services, cardiac and cardiovascular device test systems, certified silicon mock vessels, and custom simulation systems.
For a comprehensive list of software features, visit our Statys® GOA Heart Valve Analysis Software page. If you’re interested in a demonstration, contact us.