Enpath Medical Inc. (NASDAQ:NPTH), Minneapolis, has received FDA
marketing clearance for the company's steerable sheath and has
signed an exclusive license and supply agreement with Bard
Electrophysiology, a division of C.R. Bard, Inc. ("Bard") for
distribution of this product in the electrophysiology ("EP")
market. Although terms of the agreement were not disclosed, the company
stated the agreement was subject to the completion of intellectual
property due diligence and Enpath attaining CE mark approval for the
device.
"We are enthusiastic about this new opportunity because we
believe Bard is well positioned in the EP market, in part through its
long-term focus on the therapeutic treatment of cardiac
arrhythmias," said James D. Hartman, chairman and CEO of Enpath.
"Enpath's steerable sheath technology will enhance the
delivery of diagnostic and therapeutic devices in the heart. Therapeutic
EP is a large and rapidly growing market and it fits directly with
Enpath's mission to develop innovative delivery systems that
improve the quality of patient care."
The Food and Drug Administration 510(k) marketing clearance is for
Enpath's steerable sheath as a stand-alone device for a number of
procedural indications including interventional coronary, peripheral
vascular and carotid artery access. The company is in early discussions
with other potential partners regarding distribution of iterations of
the product for other attractive market segments.
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.
For more information, call 763/577-2212 or visit
http://www.enpathmed.com.
COPYRIGHT 2005 Worldwide
Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2005, Gale Group. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.