KIRKLAND, WA -- 09/05/08 --
Pathway Medical
Technologies, Inc., an innovator of endovascular treatments for
peripheral arterial disease (PAD), today announced that the U.S. Food &
Drug Administration (FDA) has given the company clearance to market
Jetstream(TM), a peripheral atherectomy catheter designed for use in the
treatment of PAD in the lower limbs. The clearance marks the company's
second 510(k) clearance and the first device on the market capable of
treating an entire spectrum of disease found in the PAD patient, including
hard and soft plaque, calcium, thrombus and fibrotic lesions with
consistent clinical results.
Pathway Medical Technologies President and CEO Tom Clement commented, "The
market introduction of Jetstream(TM) represents a major business milestone
for our organization and a dramatic new treatment option for the
endovascular community in fighting PAD. We expect the device to provide
interventionalists with the clinical versatility they seek, while providing
patients suffering from peripheral arterial disease with more predictable
outcomes. Jetstream(TM) is truly the next logical evolution in
atherectomy."
Approximately 12 million Americans suffer from the effects of PAD and many
in this rapidly expanding patient population go undiagnosed. Commonly
associated with high blood pressure, diabetes, heart disease, stroke and
aging, PAD causes a build-up of plaque within the arteries that limits
blood flow to the extremities. PAD can lead to severe limb pain,
non-healing ulcers and critical limb ischemia and, if left untreated, can
lead to gangrene, amputation and even death. The most common intervention
for PAD has historically included highly-invasive procedures, including
bypass surgery. Unfortunately, many patients are poor surgical candidates
for whom surgery can be life threatening.
Jetstream(TM) represents an innovative and minimally invasive solution to
clear blockages in the peripheral vasculature, restoring blood flow and
effectively treating PAD. Jetstream(TM) consists of a sterile, single-use
catheter and control pod and a reusable, compact console that mounts to a
standard I.V. stand. The catheter has an expandable cutting tip with
rotating blades that safely debulk and preemptively remove both hard and
soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised
tissue and thrombus are continually aspirated from the peripheral treatment
site through ports in the catheter tip to a collection bag located on the
console. The distal portion of the catheter also possesses infusion ports
that provide continuous infusion of sterile saline during the atherectomy
procedure. Active aspiration is a safety feature that minimizes the risk of
distal embolization.
According to William A. Gray, M.D., director of endovascular services,
Center for Interventional Vascular Therapy, New York-Presbyterian Hospital,
"Clinical data suggests that Jetstream(TM) is quite effective at debulking
and treating vascular disease in the peripheral vasculature. I have seen
the efficacy of the Pathway technology first hand in several cases in
Germany and look forward to treating future atherectomy candidates."
With simple set up and an ergonomic design for easy operation by trained
clinicians, Jetstream(TM) maximizes treatment effectiveness with an average
device activation time of about three and a half minutes during atherectomy
treatment. For patients, Jetstream(TM) offers renewed hope for non-surgical
candidates and the benefits of a minimally invasive treatment option,
including faster recovery and decreased systemic complications.
Jetstream(TM) delivers several cosmetic and user interface improvements
from the company's first-generation product, the Pathway PV(TM) Atherectomy
System, which was used in the company's Pathway PVD Study, a pivotal 172
patient European multi-center clinical trial completed in Germany at three
primary centers: Abteilung Angiologie in Bad Krozingen, Germany, Hamburg
University Cardiovascular Center in Hamburg, Germany, Clinical and
Interventional Angiology, Heart Center-University of Leipzig in Leipzig,
Germany.
About Pathway Medical Technologies, Inc.
Pathway Medical Technologies, Inc. was founded to design, market and
manufacture medical devices for the treatment of arterial disease. The
company's initial focus is treating peripheral arterial disease (PAD) more
quickly and effectively than existing technologies. An estimated 12 million
people are afflicted by PAD in the U.S. and that number is projected to
grow to over 20 million during the next 10 years. The company's
Jetstream(TM) device allows for a minimally invasive procedure designed to
restore circulation in the peripheral arteries by removing both hard and
soft diseased tissue. For further information, visit the company's Web site
at www.pathwaymedical.com.
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Media Contact:
Marisa Borgasano
Schwartz Communications for Pathway Medical Technologies
Tel: (415) 512-0770
PathwayMedical@schwartz-pr.com
