Coherex Medical, Inc., a privately held medical device company,
today announced it has successfully completed the first human cases of
its Coherex FlatStent(TM) PFO Closure System.
Under the direction of Professor Horst Sievert, M.D. (an
internationally renowned interventional cardiologist and Principal
Investigator for the COHEREX-EU Study), Coherex(TM) successfully
conducted procedures in Frankfurt, Germany yesterday to close the
common heart defect known as a Patent Foramen Ovale (PFO). Joining Dr.
Sievert in these cases were:
-- Brian Whisenant, M.D., Coherex founder and chairman, and
Interventional Cardiologist with the Utah Heart Clinic at LDS
Hospital in Salt Lake City;
-- Robert Sommer, M.D., Director of the Adult Invasive Congenital
Heart Services Center at New York-Presbyterian
Hospital/Columbia University Medical Center and Associate
Professor of Clinical Medicine and Pediatrics at Columbia
University; and
-- Jonathan M. Tobis, M.D., Professor of Medicine and Director,
Interventional Cardiology at the David Geffen School of
Medicine at UCLA.
"The Coherex FlatStent PFO Closure System worked flawlessly during
each of our procedures, just as we expected," Dr. Sievert said. "The
device was extremely easy to use and there have been no complications
from its use in any of the cases. The Coherex FlatStent marks the
beginning of a new era of medical device technology and significantly
raises the bar by providing a simple and safe alternative in PFO
closure for physicians and their patients."
"These fantastic results are the product of many years of research
and hard work by Coherex' employees," said Richard J. Linder, Coherex
president and CEO. "Our assertion that the Coherex FlatStent is a new
breed of stent to treat heart defects has now been successfully
validated in patients and confirms the confidence our investors have
had in our vision. We look forward to additional clinical research in
Europe as part of the COHEREX-EU Study."
These initial procedures were performed at Sankt Katharinen
Hospital in Frankfurt as part of the company's COHEREX-EU Study.
Coherex expects to include data from these cases in its application
for CE Mark clearance.
"The FlatStent technology was straightforward and extremely easy
to use and was successfully implanted in all of the patients today,"
Dr. Sommer said. "The device is unique in its construction and is
designed to sit almost entirely within the PFO tunnel, with minimal
mass and minimal left atrial exposure."
"The FlatStent technology is an exciting new advance in PFO
closure since nearly the entire device is embedded within the
inter-atrial tunnel," Dr. Tobis said. "My expectation is that the scar
tissue will remain within the tunnel and effectively close the right
to left shunt. This should have a significant effect in preventing
paradoxical emboli in stroke patients, and hopefully we can
demonstrate in future clinical trials that migraine headaches will
also be reduced with the Coherex FlatStent."
"We are thrilled to have the world's leading interventional
cardiologists participating in the COHEREX-EU Study with the Coherex
FlatStent," Dr. Whisenant said. "I found the device to be intuitive
and simple to use, and believe it may well indeed be one of the most
important advancements in the treatment of structural heart disease.
Yesterday's successful procedures reflect the incredible ingenuity and
commitment of the entire Coherex team."
About Patent Foramen Ovale (PFO) Heart Defects
A foramen ovale is a tunnel-like opening between the upper
chambers of the heart that allows blood to bypass the lungs and is
present in all fetuses. Normally, the foramen ovale closes soon after
an infant is born. However, if this opening fails to close naturally
after birth the opening is said to remain patent and the condition is
called a patent foramen ovale (PFO).
A common heart defect that occurs in roughly 25 percent of the
population, PFOs allow blood to bypass the lungs and shunt directly
from the right side of the heart to the left, thus
-- increasing the likelihood that blood clots in the heart flow
directly to the brain; and
-- preventing the filtration of chemicals out of the blood that
occurs in the lungs.
There are at least two medical conditions that may benefit from
PFO closure: stroke and migraine. According to the Stroke Council of
the American Heart Association, approximately 500,000 strokes each
year worldwide may be attributable to the presence of a PFO, which
represents a potential annual market size of close to USD 2 billion.
Migraine affects approximately 12 percent of adults. Multiple
retrospective studies have demonstrated a marked reduction in migraine
symptoms following PFO closure. As such, the worldwide market
potential for PFO closure to treat migraine patients has been
estimated to be more than USD 15 billion per year.
About the Coherex FlatStent PFO Closure System
The Coherex FlatStent PFO Closure System is similar in use and
function to self-expanding vascular stents which are widely used by
Interventional Cardiologists. However, Coherex' patent-pending
FlatStent Closure System incorporates a unique fusion of PFO closure
mechanisms and accepted medical practices in a design expected to
naturally seal a PFO tunnel.
About Coherex Medical
Formed in 2003 by Brian Whisenant, M.D., Coherex Medical is
focused on addressing structural heart disease and conditions through
medical devices. For more information, please visit www.coherex.com or
call 801-433-9900.
Coherex and FlatStent are trademarks of Coherex Medical, Inc. All
other trademarks are the properties of their respective owners.
