Scottish Equity Partners (SEP), a venture capital firm from the UK, has just invested $17 million in Heartscape Technologies (Columbia, MD), the maker of Prime™ ECG. Described as “the first major advance in non-invasive cardiovascular diagnostic devices for years,” the multi lead ECG technology is actually an old one. What’s new is the modern computing power that can churn large chunks of data, and graphically present it:
Clinical research has shown that the use of large numbers of electrode sites about the front, sides and posterior of the torso provides valuable diagnostic information that can lead to earlier diagnosis for many Acute Coronary Syndrome (ACS) patients. This procedure has traditionally been called body surface mapping (BSM). Many of these investigations were conducted in the 70’s, without benefit of the small size and speed offered by today’s computer technology. In addition, there was no practical or cost effective means to apply electrodes in a timely, convenient or cost-effective manner. As a result, BSM was not successfully commercialized.
The PRIME ECG System employs a unique two-piece electrode array (vest) that results in placement of 80 leads about the torso providing a more complete view of the electrical activity of the heart. The array is screen-printed on a clear plastic substrate. Each electrode is pre-gelled for ease of placement. Because this requires use of only 11 anatomically referenced vertical strips that are joined at their base, patient preparation and recording can be accomplished in only 15 to 20 minutes. The electrode array is attached to the recording and analysis system with two spring clips, eliminating the need for wires. The PRIME ECG system records ten seconds of ECG signals simultaneously from each of 80 electrodes.
Analysis is performed on a computer selected representative beat. ST-segment elevation and depression are translated into colors (red = elevation, blue = depression) and displayed against a 3 dimensional torso image for physician review. These images allow for rapid pattern recognition that identifies problem areas that correlate with regions of ischemia or infarction. This use of graphic imaging allows the physician to quickly focus on specific ECG morphology that contains the most valuable diagnostic information without having to expend time exploring data from all 80 leads.
System software facilitates examination of the actual ECG trace for each of the 80 recordings. The user places a cursor over the suspect area and a pop-up window reveals the underlying electrode tracing and provides the value of elevation or depression at that lead. An integrated algorithm reveals important diagnostic information, which allows interrogation. Again, placement of the cursor over the finding statement identifies the specific ECG morphology that was detected allowing the physician to locate and examine that data to confirm the finding.
Because chest pain or other symptoms of ACS can represent an evolving event, the system allows for serial recordings, which can be compared in order to identify change using colors and patterns, which can reveal worsening or improving conditions.
The device has been 510k’ed by the FDA since 2003.
Technology page: The PRIME ECG System …
Press release: Heartscape Technologies Announces Close of Series B Funding (.pdf) …
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