Vasomedical Receives FDA Approval to Begin Heart Failure Studies
WESTBURY, NY--(BUSINESS WIRE)--April 21, 1998--Vasomedical (NASDAQ:VASO; www.vasomedical.com)
announced today that it has received FDA approval to study the application of EECP(R) in the treatment of congestive heart
failure, a disabling condition affecting nearly five million Americans and the most frequent cause of hospitalization for those over
65. The study, which will begin immediately, will be conducted simultaneously at the University of Pittsburgh and at the
University of California San Francisco and is expected to be completed within 12 months. The study will not require significant
capital investment.
In a joint statement, principal investigators Arthur Feldman MD, PhD, Harry S. Tack professor and Chief, Division of
Cardiology, University of Pittsburgh and William Grossman MD, Professor of Medicine and Chief, Cardiology Division,
University of California San Francisco said, "With the prevelance of heart failure now growing so rapidly, there is a pressing
need to find new and effective methods of helping restore these patients to more functional living. Based on the positive results
of recent studies in patients with myocardial ischemia, we hope to demonstrate that EECP(R) can also benefit patients with
heart failure."
The University of Pittsburgh and the University of California San Francisco were among seven nationally recognized healthcare
institutions participating in the Multicenter Study of Enhanced External Counterpulsation (MUST-EECP) the results of which
were presented at the Annual Scientific Sessions of the American Heart Association in November 1997.
Congestive heart failure occurs when the heart is unable to pump blood well enough to meet the body's needs. The circulatory
system becomes congested when the heart fails to empty its chambers sufficiently, leading to fluid accumulation in the chest and
lower limbs. Usually, congestive heart failure begins after uncontrolled hypertension, a heart attack or heart disease damages
the heart muscle.
According to the American Heart Association, 2.5 million men and 2.4 million women in the U.S. suffer from congestive heart
failure with an estimated annual cost of $20.2 billion. As the population ages and as more people survive heart attacks, the
incidence of congestive heart failure is increasing rapidly. Currently, about 400,000 new cases are diagnosed each year.
Congestive heart failure lead to 872,000 hospital admissions in 1995 (up from 377,000 in 1979).
Vasomedical provides hospitals, clinics and private practices with equipment, EECP(R) treatment guidance and a staff training
and maintenance program to ensure optimal patient outcomes.
Except for historical information contained in this news release, the matters discussed are forward looking statements that
involve risks and uncertainties. When used in this release, words such as "anticipate", "believe", "estimate", "expect" and "intend"
and similar expressions, as they relate to the company or its management, identify forward-looking statements. Such
forward-looking statements are based on the beliefs of the company's management, as well as assumptions made by and
information currently available to the company's management. Among the factors that could cause actual results to differ
materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing;
capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the
regulatory and trade environment; and the risk factors reported from time to time in the company's SEC reports.
CONTACT: Vasomedical Inc., Westbury
Anthony Peacock, 516/997-4600 ext. 120
or
Natalie Karp
Karp Advisory
516/997-4600 ext. 776 or 516/625-9483 |
