and here's another brick in the wall: EECP may help prevent restenosis after angioplasty.
Tuesday July 24, 12:05 pm Eastern Time
Press Release
EECP May Reduce Restenosis Following Angioplasty
New Study Suggests Adjunctive Role for Vasomedical's EECP Therapy
Following Angioplasty to Prevent Restenosis
WESTBURY, N.Y.--(BW HealthWire)--July 24, 2001--Vasomedical, Inc. (Nasdaq:
VASO - news) announced today that a study presented this morning at the Second
International Congress on Heart Disease in Washington, DC suggests that EECP® therapy
following percutaneous coronary interventions (PCI) such as angioplasty and stent placement
may reduce the rate of restenosis.
Restenosis, a re-narrowing of treated arteries, occurs in approximately 30% of patients
undergoing PCI within the first six months, and repeat interventions are frequently performed
to reopen these narrowed vessels. Although a number of factors have emerged in recent
years as predictors of restenosis following PCI, smoking and the presence of diabetes clearly
place patients in a higher risk category. Last month, the company announced the results of a
study which showed EECP therapy to be well tolerated by diabetic patients and to be as
effective in reducing angina in patients with diabetes as it was for those without diabetes. It is
estimate that more than 1 million patients worldwide undergo PCI each year.
The study entitled, ``Safety and Effectiveness of Enhanced External Counterpulsation in
Improving Angioplasty Restenosis'' by lead author Tomascz P. Stys, MD of the State
University of New York at Stony Brook, looked at the rates of major adverse cardiac
events (MACE) and recurrent ischemia among 24 patients who had undergone PCI. Fifteen
of the 24 received a course of EECP® therapy following their procedures, and 9 were
randomized to usual medical care. At six months post-PCI, MACE and recurrence of
ischemia documented by radionuclide stress scintigraphy were observed in 44% of the
control group versus 13% of the group who received EECP therapy.
William E. Lawson, MD, Chief of Invasive Cardiology at Stony Brook and one of the
study's authors, stated ``Restenosis is one of the most challenging issues facing interventional
cardiologists today. Recent data suggest that diminished levels of nitric oxide in mechanically
injured or diseased arteries are linked to restenosis. Research has shown that EECP therapy
generates increased shear stress inside the blood vessel, a stimulus that augments production
of nitric oxide and appears to restore normal endothelial cell function. This, combined with
the results observed in this study, presents a new potential opportunity for affecting restenosis.''
Commenting on the study, Douglas A. Goldman, Vice President of Marketing and Business Development for Vasomedical
stated, ``There is no question that coronary angioplasty was a revolutionary advance and remains a mainstay of the
cardiologist's armamentarium in the treatment of ischemic heart disease. Restenosis, following angioplasty, however, remains a
major limitation. These latest findings suggest the potential for an adjunctive role for EECP therapy in the management of
restenosis post-PCI. We are encouraged by the results of this pilot study and as such the company plans to support future
research in this area. Managing restenosis is one of several clinical applications the company is exploring to expand the role for
EECP therapy in the treatment of coronary artery disease in the years ahead.''
Currently there are no pharmacologic therapies approved by the FDA to manage restenosis. Intracoronary radiation, or
brachytherapy, which involves the delivery of radiation via a catheter placed inside the coronary artery, has proven effective,
but is not without risks and little long-term follow-up data on this approach is available. Antiproliferative-coated stents and
photoangioplasty are also among the methods now being tested to prevent restenosis.
EECP is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system. The therapy serves to
increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function.
EECP is currently indicated for use in patients with stable or unstable angina, acute myocardial infarction and cardiogenic
shock. The company is actively engaged in research to determine potential benefits of EECP therapy in the management of
other major vascular disease states including congestive heart failure and diabetes.
Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting external counter pulsation systems
based on the Company's proprietary technology currently indicated for use in cases of angina, cardiogenic shock and acute
myocardial infarction. EECP® is a registered trademark for Vasomedical's enhanced external counterpulsation system. This
system is now in use at major medical centers, including the Beth Israel Medical Center - New York City, Christ Hospital and
Medical Center, the Cleveland Clinic, Johns Hopkins, JFK Medical Center-Atlantis, FL, Mayo Clinic, the Miami Heart
Institute, the Ochsner Foundation Hospital, the Texas Heart Institute, and University Hospital at UMDNJ/New Jersey Medical
School as well as medical centers affiliated with Columbia University, State University of New York at Stony Brook, the
University of Pittsburgh, the University of California at San Diego, the University of California at San Francisco, University of
Florida at Gainesville, and the University of Virginia. The Company provides hospitals, clinics and private practices with
EECP® equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient
outcomes. Additional information is available on the Company's website at www.vasomedical.com.
Except for historical information contained in this 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. The
Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments. |
