'Sheathlike' Design Offers Improved Ease of Use and Cuts Procedure Time
MENLO PARK, Calif., Dec. 16 /PRNewswire/ -- Perclose, Inc. (Nasdaq: PERC),
a leading manufacturer and marketer of arterial closure devices, today
announced that it successfully conducted initial human clinical testing of a
new version of its percutaneous vascular surgery (PVS) device at The Heart
Center in Siegburg, Germany. PVS devices surgically close the arterial access
site in the femoral artery following catheterization procedures such as the
six million angioplasty, stenting, atherectomy and diagnostic angiographies
performed annually. The latest generation 6 French Perclose PVS device is
designed to be inserted into the artery as easily as a standard sheath with
improved ease of use, decreased procedure time and no enlargement of the tract
or hole in the artery.
Hank Plain, Perclose's president and chief executive officer, commented,
"The latest generation PVS device represents a significant technology
advancement. We are excited about the improvements in ease of use, procedure
time, training requirements and clinical results that this device offers. We
believe that the new features of this device will allow an even broader group
of medical professionals to take advantage of the benefits of suture-based
arterial access site closure."
Dr. John B Simpson, Ph.D., M.D., Perclose's founder and chairman, stated,
"The fifth generation Perclose device was developed with the direct feedback
from our clinician users. In this market, technology and innovation wins.
Our development team has taken this design from a concept drawing to a very
successful human clinical experience in just over three months. Our engineers
have done a great job of developing a new product platform that addresses ease
of use issues while still giving the security and reliability of a surgical
closure. This latest innovation reinforces Perclose's dedication to product
improvement and commitment to our customers and their patients."
Eberhard Grube, M.D., Chief of Cardiology at The Heart Center in Siegburg,
Germany, commented, "I was very impressed with the ease of use, speed of the
procedure and most importantly, the outstanding results for our patients. It
was remarkable to be able to obtain a reliable surgical closure of the artery
without having to do any enlargement of the skin incision or the tract above
the artery."
U.S. clinical studies of this product cannot commence until the company
receives approval of a regulatory application from the U.S. Food and Drug
Administration (FDA). FDA approval will be required for commercial sales in
the United States.
Perclose, based in Menlo Park, California, 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 Ann Trunko, General Information, or Kate Rajeck, Analyst Contact, 415-986-1591, both 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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