Enpath Medical Receives CE Mark Approval for Steerable Sheath
January 06 2006 - 6:00AM
PR Newswire (US)
Approval Clears Pathway for Launch into European Electrophysiology
Market MINNEAPOLIS, Jan. 6 /PRNewswire-FirstCall/ -- Enpath
Medical, Inc. (NASDAQ:NPTH) announced today that it has received CE
Mark approval from the European Union to market its steerable
sheath, a tool that facilitates the placement of interventional
devices in the peripheral, coronary and neurovascular systems. This
approval clears the way for the Company's distribution partner Bard
Electrophysiology, a division of C.R. Bard, to launch the steerable
sheath in Europe for electrophysiology (EP) applications. "With the
U.S. Food and Drug Administration (FDA) clearance received in July,
2005, the European Union's approval positions Enpath's innovative
steerable sheath for distribution in the two largest
electrophysiology markets in the world," said Jim Hartman, Chairman
and Chief Executive Officer of Enpath Medical. Enpath's steerable
sheath features distal tip deflection to aid in the precise
placement of such devices as cardiac ablation catheters and
peripheral stent delivery catheters. "The EP market is the first of
a variety of clinical applications that can benefit from the use of
our steerable sheaths," Mr. Hartman added. "We are particularly
excited by the potential for our proprietary steerable sheath
technology to be used in the delivery of carotid artery stents and
other peripheral vessel interventions, as well as for precision
placement of implantable leads, and we are continuing to develop
the device for these indications." About Enpath Medical Enpath
Medical, Inc., headquartered in Plymouth, Minnesota, is a leader in
the design, development, manufacture and marketing of percutaneous
delivery systems and stimulation leads technologies. Its products
include venous vessel introducers, epicardial and endocardial
stimulation leads, safety needles and other products for use in
pacemaker, defibrillator, catheter and infusion port procedures as
well as neuromodulation and hearing restoration markets. Its
products are sold worldwide through partnering relationships with
other medical device companies. DATASOURCE: Enpath Medical, Inc.
CONTACT: Investors, Doug Sherk, +1-415-896-6820, or Jennifer
Beugelmans, +1-415-896-6820, both of EVC Group Web site:
http://www.enpathmed.com/
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