ESON gets FDA approval
(BSNS WIRE) EndoSonics Receives FDA Approval to Begin Human Clinical Trials
EndoSonics Receives FDA Approval to Begin Human Clinical Trials of Directional
Radiation Device for Diabetics and In-stent Restenosis
Business Editors/Health & Medical Writers
RANCHO CORDOVA, Calif.--(BW HealthWire)--May 4, 2000--EndoSonics
Corporation (Nasdaq:ESON), a leading developer and marketer of
diagnostic assessment and therapeutic treatment devices, today
announced that it has received approval from the U.S. Food and Drug
Administration (FDA) of its Investigational Device Exemption (IDE)
application to begin human clinical trials of its directional
radiation (brachytherapy) device to advance the treatment of
cardiovascular disease.
The device, named BRIGADE(TM) (Beta Radiation with IVUS Guidance
and Directed Energy), was developed in conjunction with the Cleveland
Clinic Foundation (CCF). The principal investigator for Phase I study
is Dr. Patrick Whitlow, Director of Interventional Cardiology at the
Cleveland Clinic. The clinical trial is the first in the world to
target diabetic patients who have shown a 60-70% restenosis rate in
the types of blockages to be investigated.
"We are excited to be getting underway with human clinical trials,
as we believe this device will be of significant benefit to many
cardiovascular disease patients suffering from both new coronary
artery blockage and in-stent restenosis following intervention," said
Reinhard J. Warnking, Chairman and CEO of EndoSonics. "We believe that
exact radiation dosing designed to be provided by BRIGADE will
demonstrate the distinct advantages of IVUS-guided radiation, just as
we have demonstrated the improved long-term outcomes possible through
IVUS-guided stenting."
EndoSonics Corporation, headquartered in Rancho Cordova, is a
leading developer, manufacturer and marketer of intravascular
ultrasound (IVUS) imaging products and functional assessment products
to assist in the diagnosis and treatment of cardiovascular and
peripheral vascular disease. Visit EndoSonics on the Internet at
www.endosonics.com.
Except for the historical information contained herein, the
matters discussed in this press release are forward-looking
statements, the accuracy of which is necessarily subject to risks and
uncertainties. Actual results may differ significantly from the
discussion of such matters in the forward-looking statements. Factors
that may cause such difference include, but are not limited to, delays
by regulatory authorities, scientific advances by the company or third
parties, the timely availability and acceptance of the company's new
products, the impact of competitive products and pricing, dependence
on key personnel, as well as those factors set forth in EndoSonics'
Annual Report on Form 10-K for the year ended December 31, 1999,
Quarterly Report on Form 10-Q for the quarter ending September 30,
1999, and other filings with the Securities and Exchange Commission.
--30--kwp/sf*
CONTACT: EndoSonics Corporation |
