Healthcare Industry News:  King Pharmaceuticals 

Devices Cardiology

 News Release - November 9, 2006

Heartscape Enrolls First Patient in OCCULT-MI Clinical Trial Using its PRIME ECG(R) System

COLUMBIA, Md.--(HSMN NewsFeed)--Heartscape Technologies, Inc. has announced enrollment today of the first patient in the OCCULT-MI trial. The Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT-MI) trial will measure the impact of a more complete view of the electrical signals of the heart with the PRIME ECG® System ("PRIME"), compared with the standard ECG, including time to treatment (cardiac catheterization sheath placement) for patients diagnosed using PRIME versus the time to treatment using the standard 12-lead electrocardiogram.

The first patient was enrolled in the trial by clinicians at Baystate Medical Center in Springfield, MA, according to Mitchell W. Krucoff, M.D., Professor of Medicine/Cardiology at Duke University Medical Center and Director of the eECG Core Laboratory at Duke Clinical Research Institute in Durham, NC.

Designed primarily for emergency department use, PRIME is a new diagnostic system that uses 11 easily-applied, self-adhesive plastic strips containing 80 data collection points, or leads, to cover the front and back of the body. The 11 strips allow analysis of the heart's electrical activity with 360 degrees of spatial resolution, which has the potential to detect critical diagnostic information not visible with a traditional electrocardiogram. Data from the 80 leads are processed by an interactive algorithm that suggests findings and can provide important details necessary to achieve an accurate diagnosis.

Data collected in previous studies have demonstrated that PRIME has the potential to offer significant benefits in the early diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) that is not identified by the current 12-lead ECG (Occult STEMI). In published studies completed over 10 years involving more than 2,500 patients, PRIME has been shown to be significantly more sensitive than current standard ECG testing in the immediate detection of such heart attacks. The earlier detection and expanded information provided by the PRIME system empowers physicians with greater diagnostic insight to assess patient risk and evaluate the benefits of early intervention, a central factor in reducing patient death and morbidity.

"The addition of many leads to create a more complete ECG (body surface mapping) has consistently been shown in studies to add important diagnostic information when compared to the standard 12-lead ECG. With PRIME, physicians can easily collect and quickly analyze these data in real-time - even in an emergency room setting," said Mitchell W. Krucoff, M.D., co-principal investigator for OCCULT-MI. "This technology is not only about faster treatment, but about more accurate diagnosis. It has huge ramifications for emergency room triage of patients with chest pain. I look forward to the results of this study, which will allow us not only to measure early detection of STEMI for more patients, but to detect additional benefits for the evaluation of chest pain."

"Heartscape is pleased to be working with some of the nation's leading clinicians and academic clinical research sites to conduct this study of the PRIME technology. The results of this research will not only provide us with new insights into which patients are most likely to benefit from this diagnostic advance; it also provides us with the knowledge to potentially define how hospitals can most effectively apply PRIME capabilities to create efficiencies that save lives and lower patient morbidity," remarked Arthur Hiller, Chief Executive Officer of Heartscape.

The OCCULT-MI study will enroll approximately 1,400 patients in a blinded, multi-center clinical study. The primary endpoint measures door to sheath time (DTST), in minutes, for PRIME-only STEMI patients vs. STEMI patients diagnosed by the standard 12-lead ECG. Time will be assessed from patient presentation to the hospital's emergency department to the time of sheath insertion in the cardiac catheterization laboratory. Secondary endpoints will evaluate the impact of PRIME on various measures including cost of care, clinical diagnosis and outcomes and the role of PRIME in assessing risk in patients with cardiac ischemia. In addition to Baystate Medical Center, there are nine other clinical research centers participating in the trial.

In September 2005, Heartscape acquired the PRIME business and all the related assets from King Pharmaceuticals, Inc. PRIME ECG was developed over 10 years and is the product of a $25 million investment by corporate predecessors.

About Heartscape Technologies, Inc.

Heartscape is engaged in the development and marketing of the PRIME ECG® System, an FDA-cleared medical device that accurately and rapidly diagnoses heart attacks and ischemia in the emergency department setting - enabling earlier intervention, a central factor in reducing patient death and morbidity. Heartscape currently has sales and operations offices located in Columbia, Maryland, and R & D and manufacturing facilities in Bangor, Northern Ireland. Developed in collaboration with the University of Ulster in Northern Ireland, the PRIME technology provides the hospital acute cardiac care team with an 80-electrode, 360-degree view of the heart's electrical activity to more accurately identify abnormal signals that may indicate a heart attack in areas not visible to the current 12-electrode standard electrocardiogram (ECG). The PRIME system consists of a rapidly administered, single-use, disposable plastic vest that connects to a compact, mobile computer workstation allowing users to view the heart's electrical activity using multiple display options that offer traditional ECG tracings or easily-interpreted 3D graphics.

PRIME ECG is a registered trademark of Heartscape Technologies, Inc.


Source: Heartscape Technologies

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