PR Newswire, Thursday, November 13, 1997 at 16:40
BOSTON, Nov. 13 /PRNewswire/ -- Nitinol Medical Technologies, Inc.
(Nasdaq-NNM: NMTI) today announced preliminary clinical results for the
Company's CardioSEAL(TM) Septal Occluder presented by two investigators at the
annual meeting of the American Heart Association held in Orlando, Florida.
Evan M. Zahn, M.D. from Miami Children's Hospital, Miami, Florida,
reported the initial results from a multi-center North American clinical trial
for use of the CardioSEAL for transcatheter closure of isolated secundum
atrial septal defects ("ASD") in patients considered to be candidates for
open heart surgical repair. Of 82 patients implanted with the CardioSEAL, 96%
achieved a clinically successful result. Dr. Zahn concluded that this
preliminary data suggests that the CardioSEAL is a safe and effective device
for transcatheter ASD closure.
Kathy J. Jenkins, M.D. reported on the initial experience with the use of
the CardioSEAL for transcatheter closure of complex cardiac defects in high
risk patients in a study sponsored by Children's Hospital in Boston. Patients
enter the trial following the determination by an independent medical review
committee that they are at high risk of morbidity/mortality if treated
surgically. Dr. Jenkins reported on 117 patients implanted with 162
CardioSEAL devices between May 1996 and August 1997 for a variety of cardiac
defects, including ASD, ventricular septal defects, patent foramen ovale (PFO)
and fenestrated fontan. Dr. Jenkins concluded that the findings suggest that
the CardioSEAL will be an important alternative to surgery for high risk
patients.
Thomas M. Tully, President and Chief Executive Officer of Nitinol Medical
Technologies commented, "We continue to be very encouraged by the worldwide
clinical experience with the CardioSEAL Septal Occluder. The preliminary
findings reported at the American Heart Association meeting suggest both the
effectiveness of the CardioSEAL and the potential versatility of the device
for a variety of clinical applications. Further investigations of the device
are ongoing in North America. The CardioSEAL is commercially available in
most countries elsewhere in the world."
Nitinol Medical Technologies, Inc. designs, develops, and markets
innovative medical devices that utilize advanced technologies and are
delivered by minimally invasive procedures. The Company's products are
designed to offer alternative approaches to existing complex treatments,
thereby reducing patient trauma, shortening procedure, hospitalization and
recovery times, and lowering overall treatment costs. The Company's patented
medical devices include self-expanding stents, vena cava filters and septal
repair devices.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties or
other factors which may cause actual results, performance or achievements
of the Company to be materially different from any future results, performance
or achievements expressed or implied by such forward-looking statements.
Factors that might cause such a difference include, but are not limited to,
those discussed under the heading "Certain Factors That May Affect Future
Results" included in the Management's Discussion and Analysis of Financial
Condition and Results of Operations in the Company's Annual Report on Form 10-
K for the year ended December 31, 1996 and in the Company's 1996 Annual Report
to Stockholders, and in documents subsequently filed by the Company with the
Securities and Exchange Commission.
To receive Nitinol's latest news release and other corporate documents via
FAX -- no cost -- please dial 1-800-PRO-INFO. Enter Nitinol's ticker-NMTI.
SOURCE Nitinol Medical Technologies, Inc.
-0- 11/13/97
/CONTACT: Thomas M. Tully, President & CEO of Nitinol Medical
Technologies, 617-737-0930; General, Paula Schwartz, Analysts, Brian Gill,
Media, Deanne Eagle, 212-661-8030, or Analysts, Kathy Brunson, 312-266-7800,
all of The Financial Relations Board/ |
