MENLO PARK, Calif., Aug. 17 /PRNewswire/ -- Perclose, Inc. (Nasdaq: PERC)
today announced that it successfully conducted initial human clinical testing
of its Heartflo(TM) distal anastomosic device in coronary artery bypass graft
(CABG) procedures.  The Heartflo device automates the surgical connection
(anastomosis) of blood vessels during CABG procedures.
    The most critical part of a CABG procedure is the anastomosis, or the
suturing and connection of bypass vessels to coronary arteries.  This allows
blood to bypass circulatory blockages caused by the build up of
atherosclerotic plaque.  By automating the placement and deployment of sutures
in the bypass vessels and coronary arteries, the Heartflo device provides a
precise, consistent and repeatable suture pattern for cardiac surgeons to use
to complete the anastomosis process.  The introduction of minimally invasive
cardiac surgery has further accentuated the need for an automated suturing
approach due to the challenges of working through small incisions in the
chest, often on a beating heart.  There are approximately 540,000 CABG
procedures performed worldwide each year, with 340,000 of these occurring in
the United States.
    Sam Lichtenstein, M.D., Chief of Cardiovascular Surgery, St. Paul's
Hospital, Vancouver, Canada, said, "The precision of the Heartflo suture
deployment allowed me to replicate the ideal hand sewn pattern for the distal
anastomosis.  The device performed extremely well, automating the delivery of
ten needles and sutures to the coronary artery and saphenous vein in a
straightforward and predictable manner.  I believe that the Heartflo device
will enhance the cardiac surgeon's ability to efficiently perform routine
anastomoses.  In addition, it should enable more consistency in the more
challenging anastomoses associated with the evolving, less invasive approaches
to coronary bypass surgery.  Because the quality of the anastomosis is the
greatest predictor of long term patient outcomes, I think the Heartflo device
will have a significant impact on the results we are able to provide our
coronary bypass patients."
    Hank Plain, Perclose's president and chief executive officer, commented,
"We are excited about reaching this important milestone in the development of
the Heartflo System.  This extends our core competency and intellectual
property base into a second, clinically important cardiovascular product with
a very significant market opportunity."
    U.S. clinical studies of Heartflo cannot commence until the company
receives approval of an investigational device exemption (IDE) from the U.S.
Food and Drug Administration (FDA).  FDA approval of a pre-market approval
(PMA) application will be required for commercial sales in the United States.
    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.  The patented, proprietary
Prostar and Techstar 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.

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