Commercial release of Del Mar Medical Systems' Impresario Holter data analyzer is anticipated in March pending completion of beta-site testing and finalization of certain design aspects such as screen layout, the firm says. The device gained 510(k) clearance in November.

The Windows-based Impresario software, which can be used on any standard PC, facilitates the interpretation of ECG data recorded by Holter devices. The system uses visual basic programming instead of conventional C++, facilitating data transmission, multi-tasking and future product enhancements, Del Mar explains. The Impresario also incorporates existing Del Mar analyzer capabilities including an arrhythmiagraph feature for graphic representation of ECG waves; audiovisual super-imposition electronic presentation for visualization of every heart beat in a 24-hour study; and a morphology feature, a confirm mode for prospective analysis.

A 510(k) is pending for Del Mar's Aria Holter recorder, a lightweight (3.5 ounce), four-lead digital system. The "smallest-ever" three-channel device is "so lightweight, patients will barely know they're wearing it," Del Mar claims. The Impresario and Aria are the most recent additions to the Del Mar Holter line. Among the firm's most popular existing systems are the DigiCorder and FlashCorder digital Holter monitors and Electrocardiocorder analog Holter system, as well as AccuPlus and DartScan analyzers. Del Mar also sells ambulatory blood pressure monitors.

The company has a direct sales force of six in the U.S. backed by 15 service reps. Overseas, Del Mar uses distributors in 40 countries and some direct reps in Belgium. The former medical products division of privately held Del Mar Avionics was established as a separate, limited-liability corporation in October 1999, giving the business greater autonomy from the parent's non-medical operating divisions.

Irvine, California-based Del Mar Medical has 120 employees, annual sales in the $15-20 mil. range and is profitable. Annual growth in the mid-single digits has recently accelerated into the double-digit range, Del Mar says, despite the fact that it competes in a relatively mature, flat growth market against larger, more resourceful firms like GE/Marquette. Del Mar estimates it has about 35% of the U.S. market.

Del Mar Medical Impresario Holter Data Analyzer Debut Slated For March

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