Quantitative angio device applied to echocardiography

CMS-Echo to provide image edge analysis

A three-year old Dutch company has applied to the Food and DrugAdministration for 510(k) clearance of an off-line workstationfor quantitative angiography edge-detection analysis. This contourdetection technology will be applied next to the field of quantitativeechocardiography.

Medical Imaging Systems (Medis) has sold over 30 of its angiographyCardiovascular Measurement Systems (CMS) worldwide, mostly inEurope, according to Douglas F. Orr, president of Medis' U.S.company of the same name, based in Ridgefield, CT.

CMS is currently used by core research cardiac cath labs todevelop scientific image analysis in support of applications formarket certification of drugs and interventional devices, Orrsaid. Since there are only a half-dozen of these research labsin the U.S., however, the device's real market potential liesin clinical cardiac cath applications, such as determining stenosissize and guiding interventional therapy.

Medis is also seeking to expand into echocardiography withCMS-Echo, an echo version of the workstation. To adapt its CMStechnology to cardiac ultrasound, Medis has enlisted the helpof market leader Hewlett-Packard, which has provided its scannerprotocols to Medis. This will allow HP image and Acoustic Quantificationdata to be transferred directly into the CMS-Echo workstationfor further quantitative cardiac analysis.

Medis anticipates filing a 510(k) application for CMS-Echoin September, Orr said. This ultrasound analysis system has notyet been placed in clinical sites, either in the U.S. or internationally.

CMS incorporates advanced edge analysis programming, specificallyan algorithm known as minimum-cost contour tracking, Orr said.Medis then applied this technology to ultrasound image analysisin the CMS-Echo workstation, which will be priced at $50,000 orless.

Image data will be imported into CMS-Echo either through frame-grabbingscanner video output or direct digital links. As with the angiographyCMS system, initial applications of the echo system will focuson research until the clinical utility of the quantitative datais clarified.

Eventually, CMS-Echo quantitative data should provide clinicalstress-echo information, such as ejection fractions and wall-motionanalysis, Orr said. It may also become a way to provide reproduciblemonitoring over time of cardiac treatments.

Medis is currently developing a real-time contour detectionboard that will enable real-time, frame-to-frame wall motion analysis.