SAN DIEGO--(BUSINESS WIRE)--Sept. 18, 1996-- CardioDynamics International Corp. (CDIC) announced that the article published in today's Journal of the American Medical Association (JAMA), which questions the safety of invasive right heart catheters, has significance for CardioDynamics' noninvasive technology and their BioZ System hemodynamic monitor.
The JAMA article highlights the costs and the risks of complications and death associated with the invasive technology.
Dr. Nicholas Diaco, director of the Cardiac Catheterization Laboratory at St. John's Hospital in Santa Monica, Calif. and a CardioDynamics' board member, said, "the article confirms the numerous risks associated with the invasive procedure and underscores the need for noninvasive alternatives."
Dr. William Maguire, M.D., Ph.D, a critical care specialist at Grossmont Sharp Hospital in San Diego, added that "the problems lie with the right heart catheter." He also stated that "the need for the hemodynamic data exists and that this study makes the pursuit of noninvasive technology, such as CardioDynamics' noninvasive thoracic electrical bioimpedance (TEB), paramount." Dr. Maguire is a member of CardioDynamics' medical advisory board.
CardioDynamics' proprietary noninvasive technology allows for assessment and trending of parameters similar to those provided by the invasive right heart catheters, such as the popular Swan-Ganz catheter.
CardioDynamics has recently filed a 510(k) on its BioZ System which is currently being utilized in clinical studies at Brigham and Women's Hospital, Scripps Clinic and Research Foundation, University of California at San Diego, University of Washington and Mayo Clinic (Rochester). The studies will include analysis of patient outcomes and cost efficiencies realized through the use of the company's noninvasive hemodynamic monitors.
A June 15, 1996, article published in the American Journal of Cardiology comparing CardioDynamics' noninvasive technology with invasive procedures, including the right heart catheter, concluded that there were no significant differences in the stroke volume and cardiac output hemodynamic data obtained by TEB and right heart catheters.
The article stated that TEB is a noninvasive, simple, accurate and reproducible technique. An additional and important advantage of CardioDynamics' noninvasive technology is its substantially lower cost, given that the invasive right heart catheter is associated with approximately $2 billion in medical costs annually in the United States.
CardioDynamics' new system, the BioZ, is a digital signal processor-based noninvasive hemodynamic monitoring system. With the BioZ System, the company expects to expand on its installed base of over 1500 hemodynamic monitors worldwide. The company estimates a potential market of $2 billion for its products.
CardioDynamics International Corp. is a San Diego, Calif.-based developer and marketer of noninvasive cardiac output monitoring systems which use its patented Thoracic Electrical Bioimpedance technology. For further information, contact: Richard E. Otto, chief executive officer or Rhonda F. Pederson, chief operating officer, at (800) 778-4825. |
