SAN DIEGO, March 17 /PRNewswire-FirstCall/ -- CardioDynamics , the innovator and leader of impedance cardiography (ICG) technology, today announced publication of the ED-IMPACT trial, which demonstrated that information from its BioZ(R) ICG device resulted in a change in treatment 39% of the time and a change in emergency department (ED) diagnosis 13% of the time in patients presenting with shortness of breath. The results were published online in Academic Emergency Medicine, a leading emergency medicine journal, and will be published in print version of the journal in April 2006.
The ED-IMPACT trial was conducted at the Cleveland Clinic in Cleveland, Ohio, and the University of Mississippi in Jackson, Mississippi. A total of 89 patients presenting with shortness of breath were enrolled, 48% with congestive heart failure and 22% with chronic obstructive pulmonary disease. Without knowledge of BioZ data, ED physicians completed a history and physical exam for each patient and documented initial diagnosis and treatment plan. The ED physician was then shown the BioZ data and any changes in diagnosis and treatment plan were noted. BioZ data changed diagnosis in 13% of patients and changed medications administered in 39% of patients. In comparison, in a study published in Circulation, pulse oximetry, which is considered the de facto fifth vital sign by most clinicians, changed therapy in less than 9% of ED patients.
Frank Peacock, M.D., Vice-Chair of Research in the Emergency Department at the Cleveland Clinic, and principle investigator of the trial, commented, “Given the high morbidity and mortality rates and high cost of re-admissions, it is essential that emergency departments examine new strategies for treatment of older patients with shortness of breath. In this study, the provision of ICG data to treating physicians changed the course of treatment in almost 40% of patients. In addition to the significant therapeutic contributions of ICG technology, it also is very helpful in differentiating heart failure from other conditions associated with shortness of breath.”
In a recent New England Journal of Medicine published study of 17,991 patients visiting the physician office, shortness of breath was a stronger predictor of death than the commonly-known symptom of chest pain. In that study, patients complaining of shortness of breath were more than twice as likely to die of a cardiac cause than those with chest pain. Additionally, shortness of breath is one of the most common complaints for older patients visiting the ED, accounting for approximately three million ED visits annually.
Michael K. Perry, CardioDynamics’ Chief Executive Officer, added, “Our mission is to fundamentally change drug management with ICG. Shortness of breath is a difficult symptom to assess and treat for physicians in the ED or in a physician office setting, so we are pleased to have these impressive study results published, and demonstrating ICG significantly contributes to the care of these patients. In the first half of 2006, we will see the publication and broad medical community distribution of three major studies, ED-IMPACT in shortness of breath, CONTROL in high blood pressure, and PREDICT in heart failure. Together, these studies provide strong rationale for the use of ICG in treating cardiovascular disease, and are the foundation for continued market development and third-party payor acceptance of ICG technology.”
About CardioDynamics:
CardioDynamics , the ICG Company, is the innovator and leader of an important medical technology called impedance cardiography (ICG). The Company develops, manufactures and markets noninvasive ICG products and medical device electrodes. The Company’s ICG Systems are being used by physicians around the world to help battle the number one killer of men and women -- cardiovascular disease. Partners include GE Healthcare and Philips Medical Systems. For additional information, please refer to the company’s Web site at www.cdic.com.
Forward-Looking (Safe Harbor) Statement:
Except for the historical and factual information contained herein, this press release contains forward-looking statements the accuracy of which is necessarily subject to uncertainties and risks including publication and distribution of clinical study results, the Company’s sole dependence on the BioZ product line, market acceptance, and various uncertainties characteristic of early growth companies, as well as other risks detailed in the Company’s filings with the SEC, including its 2005 Form 10-K. The Company does not undertake to update the disclosures contained in this press release.
CardioDynamics
CONTACT: Cindy Presar, Investor Relations of CardioDynamics,+1-800-778-4825, ext. 1031, cpresar@cardiodynamics.com
Web site: http://www.cdic.com//
