MENLO PARK, Calif., Jan. 12 /PRNewswire/ -- Perclose, Inc. (Nasdaq: PERC)
today announced that the United States Food & Drug Administration (FDA) has
approved an expanded range of users for the Perclose Prostar(R) and
Techstar(R) percutaneous vascular surgery (PVS) devices consisting of other
healthcare professionals in addition to physicians. Examples of these
recently approved non-physician users are physician assistants, nurses,
technicians and other qualified healthcare personnel.
Hank Plain, Perclose's president and chief executive officer, commented,
"The recent approval expands the number and type of healthcare professionals
authorized to use Perclose products. With this expanded use, Perclose is
enabling its customers, cardiology and radiology catheterization laboratories,
to more efficiently manage their personnel requirements, staffing schedules,
intensity of nurse monitoring and use of hospital beds. This approval
highlights our focus on R&D and regulatory programs that continually improve
the ease of use of our products and facilitate the rapid adoption of Perclose
technology."
Perclose, based in Menlo Park, Calif., designs, manufactures and markets
less invasive medical devices that automate the surgical closure or connection
of blood vessels. The Prostar(R) and Techstar(R) products, marketed in the
U.S. and internationally, surgically close the arterial access site in the
femoral artery following catheterization procedures such as angioplasty,
stenting, atherectomy and diagnostic angiography. These patented, proprietary
products offer superior clinical treatment, more rapid recovery and a more
cost-effective alternative to the standard method of closing arterial access
sites. The Heartflo(TM) System, which automates the surgical connection of
blood vessels during conventional and minimally invasive coronary artery
bypass surgery, is in human clinical testing. Perclose common stock is traded
on the Nasdaq National Market under the symbol PERC.
Except for the historical information contained herein, the matters
discussed in this news release are forward looking statements that involve
risk and uncertainties, including the risk that new products may not prove to
be safe or effective in clinical trials, risks associated with receipt and
timing of regulatory approvals, including approvals to conduct clinical trials
and to commercially market products, market acceptance of new products, risks
of adverse determinations in litigation relating to patents and intellectual
property rights, risks associated with manufacturing scale-up and increases in
production volumes, risks associated with product recalls and the management
of growth. For further information, refer to the risk factors in the most
recent periodic filings with the Securities and Exchange Commission.
SOURCE Perclose, Inc.
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CONTACT: Ken Ludlum, Chief Financial Officer of Perclose, Inc., 650-473-3100, ext. 278; or general information, Ann Trunko, or analyst contact, Kate Rajeck, 415-986-1591, of The Financial Relations Board
NOTE TO EDITORS: For more information on Perclose via fax at no cost, call 800-PRO-INFO (+732-544-2850 outside the U.S), ticker symbol PERC.
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