Vasomedical, Inc. (Nasdaq SmallCap: VASO.S) announced today that its
proprietary EECP(R) enhanced external counterpulsation system has been
granted a 510(k) market clearance from the Food and Drug
Administration (FDA) for a new indication for the treatment of
congestive heart failure.
The 510(k) clearance applies to Vasomedical's Model TS-3 EECP
system that includes the Company's patent-pending congestive heart
failure treatment and oxygen saturation monitoring technologies.
"With this new indication, we estimate that the percentage of
eligible patients within the average medical practice who would likely
benefit from EECP could grow from 2% to upwards of 15% to 20%," said
D. Michael Deignan, President and Chief Executive Officer of
Vasomedical. "These patient volumes would translate into a market
opportunity for our cleared indications of an estimated $2 billion in
sales and services over the next several years in the United States
alone."
Congestive heart failure afflicts more than 5 million people in
the United States alone, with more than 550,000 new patients diagnosed
every year. It is the single most expensive disease state in the
nation, accounting for more than $40 billion in direct and indirect
medical costs.
"This development opens a vast and exciting market opportunity for
us years ahead of our most optimistic projections," said Deignan. "We
believe this non-invasive, cost-effective therapy will provoke a
paradigm shift in the way cardiovascular diseases come to be treated.
We will continue to sponsor scientific research to better demonstrate
external counterpulsation's efficacy and further explain its
mechanisms of action."
Results presented in 2000 of a pilot study involving 26 patients
with heart failure who received EECP treatment showed significant
improvement in exercise capacity, quality of life and improved oxygen
utilization at six months post-treatment. The Company is currently
sponsoring the PEECH(TM) trial (Prospective Evaluation of EECP in
Congestive Heart Failure), a large, multi-center, randomized
controlled clinical study that will evaluate improvements in exercise
capacity and quality of life in heart failure patients. The Company
will also sponsor an educational symposium at the Scientific Sessions
of the Heart Failure Society of America in Boca Raton in September to
review existing clinical data and formally launch the use of EECP for
the treatment of heart failure before a scientific audience.
The Company understands from discussions with the FDA that one
reason for the change in the regulatory status of EECP for the
treatment of congestive heart failure was the result of the agency's
reassessment of the system's safety profile. This latest decision
reverses a June 2000 determination by the FDA that use of the EECP
device for the treatment of congestive heart failure would require an
approved Pre-Market Approval (PMA), a more rigorous and time consuming
testing standard than that required for a 510(k) clearance, before
marketing. |
