REDWOOD CITY, Calif., May 18 /PRNewswire/ -- Perclose, Inc. (Nasdaq: PERC)
today announced that the FDA has approved the use of a labeling claim of
reduced time to discharge for the Techstar(R) 6F and Prostar(R) 8F products
when used after diagnostic catheterization procedures in patients who have no
other medical conditions which require hospital observation. The Perclose
Percutaneous Vascular Surgical products are the only medical products on the
market approved for a labeling claim of reducing the length of stay for
cardiac catheterization patients. Along with the reduced time to discharge
claim, the Techstar 6F product was also granted the labeling claims of reduced
time to hemostasis and reduced time to ambulation, which were previously
granted for the Prostar 8F. These times are important measures of efficiency
and cost savings for hospitals.
The reduced time to discharge claims were granted based on rigorous
clinical studies titled STAND I and STAND II, which were independently managed
by the Cardiovascular Data Analysis Center (CDAC), Harvard Medical School.
These studies showed that diagnostic patients treated with these devices left
the hospital earlier than patients treated with conventional methods.
Hank Plain, Perclose's president and chief executive officer, commented,
"This is an important milestone for Perclose and shows that our technology
offers definitive clinical benefits for patients and an economic benefit for
hospitals. Perclose is the first vascular closure device to show a reduction
in time to discharge. "Hospitals using our technology have been demonstrating
that they can change clinical pathways and lower their overall cost of
treatment. Now hospitals can allow catheterization patients to return home to
their families sooner unless they have other clinical reasons to remain in the
hospital."
Perclose, based in Redwood City 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. The patented,
proprietary Prostar and Techstar products offer more rapid recovery and a more
cost-effective alternative to the standard method of closing arterial access
sites. The Heartflo(TM) System, which is designed to automate the surgical
connection of blood vessels during conventional and minimally invasive
coronary artery bypass surgery, is in development. Perclose common stock is
traded on the Nasdaq National Market under the symbol PERC.
Certain statements in this news release, including statements relating to
the Company's growth, profitability and financial results and the Company's
product development efforts, contain forward looking information. The
Company's actual results may differ from those anticipated by such forward-
looking statements due to risks 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 market products commercially,
market acceptance of the Company's products, risk 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 and other
risks, including those set forth in the Company's periodic filings with the
Securities and Exchange Commission.
For more information on Perclose via fax at no cost, call 800-PRO-INFO,
ticker symbol PERC.
SOURCE Perclose, Inc.
back to top
CONTACT: Ken Ludlum, Chief Financial Officer of Perclose, Inc., 650-473-3100 ext. 278; or general information, Traci McCarty, analysts, Kate Rajeck, or media, Scott Marx, 415-986-1591, all of The Financial Relations Board
|