Watching to see if it can move on news;
BOSTON, Sept. 28 /PRNewswire/ -- NMT Medical (Nasdaq: NMTI) today
announced that it has received notification from the Food and Drug
Administration ("FDA") of the approval of the CardioSEAL(R) Septal Occluder
under Humanitarian Use Designation ("HUD") regulations. This is the second
such approval the Company has received for the device.
In this case, the CardioSEAL Septal Occluder, a cardiac implant designed
to close holes in the heart, has been approved under HUD for closing
ventricular septal defects which cannot be closed using standard surgical
approaches. Ventricular septal defects ("holes"), located at the rear of the
septum or at the base of the heart, are particularly difficult to close
surgically due to poor visualization by the surgeon. Up to 4,000 patients can
be treated per year for each indication approved under HUD. The regulations
provide for approval of only one device type for each designated indication.
Management believes that up to 2,300 patients with these remotely located
ventricular septal defects could be candidates for the CardioSEAL implant each
year in the U.S.
Under HUD regulations, medical devices that provide safe treatment for
limited populations of patients can be granted approval by the FDA based on
more limited clinical experience than that required for a full Pre-Market
Approval (PMA). NMT Medical has collaborated with Boston Children's Hospital
to utilize clinical data generated in a multi-center trial sponsored by the
hospital for the treatment of different types of septal defects in high-risk
patients.
On September 9, 1999, the Company announced the approval of the CardioSEAL
Septal Occluder under HUD for closing fenestrated Fontan procedures. The
fenestrated Fontan procedure is a surgical procedure utilizing a graft (e.g.,
PTFE material) to redirect blood flow in patients born with seriously
malformed hearts. As a part of this procedure, a fenestration, or hole, is
placed in the graft to allow the patient to adjust over time to the new
hemodynamics created by the surgery, thereby reducing post-operative morbidity
and mortality. After the patient has adjusted, the closure of the
fenestration is desirable. However, re-operation of these patients to close
the fenestration can carry significant risk. The U.S. population for
fenestrated fontan procedures is estimated at approximately 2,300 patients per
year.
Commenting on today's news, Thomas M. Tully, President and Chief Executive
Officer of NMT Medical, said, "We are very pleased with this additional timely
approval action by the FDA. This will allow us to offer the CardioSEAL to an
even broader population of patients most in need of an alternative to surgery.
Once again, we are very grateful to Children's Hospital for their efforts in
generating the clinical data necessary for this approval and for their
collaboration with us on the approval application."
NMT Medical 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 medical devices include self-expanding stents,
vena cava filters and septal repair devices. The NMT Neurosciences division
serves the needs of neurosurgeons with a range of products including cerebral
spinal fluid shunts, the Selector(R) Ultrasonic Aspirator, Ruggles(TM)
Surgical Instruments, the Spetzler(TM) Titanium Aneurysm Clip, and endoscopes
and instrumentation for minimally invasive surgery.
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, 1998.
To receive NMT Medical's latest news release and other corporate documents
via FAX -- at no cost -- please dial 1-800-PRO-INFO. Enter the Company's
symbol NMTI.
SOURCE NMT Medical
-0- 09/28/1999
/CONTACT: Thomas M. Tully, President & CEO of NMT Medical, 617-737-0930;
General Info, Paula Schwartz, Analyst Info, Brian Gill, or Media Info, Deanne
Eagle, all of The Financial Relations Board, 212-661-8030, for NMT Medical/
(NMTI) |
