Changing the subject, somewhat, back to biotech day trades...
With news like this, I bought.
Am I right or wrong?
FDA approval is so slow and difficult. Flash. 11 am. Victory.
Where were the troops?
All opinions welcome.
Thanks
========================
Wednesday November 20 11:08 AM EDT
Nitinol Medical Technologies Receives
FDA Approval for Subclavian Implantation of its Simon Nitinol Filter
Company Continues to Offer Largest Number of Delivery Options to a $53 Million Worldwide Market
BOSTON, Nov. 20 /PRNewswire/ -- NITINOL MED today announced
that it has received 510(k) clearance from the Food and Drug
Administration ("FDA") to market its Simon Nitinol Filter
("SNF) for implantation through the subclavian vein in the
shoulder. The patented SNF, which received FDA approval in
1990, is a thermal shape-memory nitinol vena cava filter
designed to prevent pulmonary embolisms. The approval of this
additional access route provides increased opportunity for
physicians to adapt their existing implantation techniques to
individual patient conditions and anatomies. With thisapproval, Nitinol Medical continues to provide the widest
variety of delivery options (leg, neck, arm and shoulder) for
any vena cava filter currently on the market.
A pulmonary embolism occurs when a blood clot lodges in the
vessels supplying blood to the lungs -- a condition which
results in approximately 125,000 to 150,000 deaths annually
in the U.S. and represented a $53 million worldwide market in
1995. Nitinol's SNF is implanted using the Company's
patented, catheter-based delivery systems in a minimally
invasive procedure. The SNF is distributed worldwide by C.R.
Bard, Inc., a leader in sales of minimally invasive medical
devices.
Thomas M. Tully, President & CEO of Nitinol Medical
Technologies, Inc., stated, "The clearance of the SNF for
delivery through the subclavian vein provides our customers
with increased flexibility in adapting the implantation of
the device to each patient. No other currently available vena
cava filter provides such a wide range of access options."
Nitinol Medical Technologies, Inc. designs, develops, and
markets innovative medical devices that utilize advanced
materials 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.
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. |
