News
(http://www.transcendmedical.com/)
Transcend Medical, Inc., an ophthalmic device company dedicated to
developing minimally invasive glaucoma therapies, announced that the
CyPass Micro-Stent@ will be the subject of four clinical presentations
this week at the American Society of Cataract and Refractive Surgery
(ASCRS) annual meeting.
"These ASCRS abstracts, and in particular the preliminary twelve-month
CyCLE data from our international colleagues, demonstrate the
potential for the CyPass Micro-Stent to safely reduce and stabilize
intraocular pressure over time with minimal side effects," commented
Steve Vold, MD, Steering Committee Chairman for the COMPASS clinical
trial, which is evaluating the CyPass@ device in the United States.
The four scientific abstracts accepted for publication include:
The CyPass Micro-Stent is the first micro-invasive glaucoma stent
designed to drain aqueous fluid toward the suprachoroidal space. It is
designed to reduce intraocular pressure (IOP) by bypassing the
trabecular meshwork and Schlemm's canal -- drainage paths that may be
diseased in glaucomatous eyes -- and by enhancing uveoscleral outflow,
one of the eye's alternative, natural drainage pathways. This device
is currently being studied in combination with cataract surgery in the
COMPASS multicenter clinical trial, one of the largest randomized,
controlled, studies in surgical glaucoma to date.
"We are encouraged by both the clinical data and our overall progress
with the CyPass Micro-Stent technology," said Brian Walsh, President
and Chief Executive Officer of Transcend Medical. "In the U.S., the
COMPASS pivotal trial, which has already achieved 50 percent
enrollment, has set a new standard for surgical device trials in the
mild-to-moderate glaucoma population in that it is designed to
evaluate product risks and benefits through two years of follow-up
while eliminating the confounding factor of glaucoma medication use."
Ike K. Ahmed, MD, FRCSC, Assistant Professor at the University of
Toronto, stated, "To date, the CyPass Micro-Stent is the most studied
minimally invasive device that takes advantage of the high potential,
pressure-lowering physiology of the suprachoroidal drainage path.
Implanting the CyPass device is a very straightforward procedure,
resulting in IOP-lowering and quick recovery."
About the CyPass Micro-Stent@
The CyPass Micro-Stent is the first micro-invasive glaucoma stent
designed to drain aqueous fluid toward the suprachoroidal space. It is
about the size of a grain of rice and is made of polyimide, a highly
biocompatible polymer. Once in place, the CyPass Micro-Stent is
designed to provide 24-hour IOP control, which may reduce the risk of
glaucoma disease progression. While CE mark for the device was granted
in 2008, the CyPass Micro-Stent is for investigational use only.
About the COMPASS Clinical Study
The COMPASS clinical study, which is under way at over 20 study sites
in the U.S., is a large randomized, controlled trial evaluating the
CyPass Micro-Stent in combination with cataract surgery against
cataract surgery alone for the treatment of glaucoma. For more
information about the study, please visit
www.compassclinicalstudy.com(http://ctt.marketwire.com/?release877449&id1512487&type1&urlhttp%3a%2f%2...).
About Transcend Medical, Inc.
Transcend Medical
(www.transcendmedical.com(http://ctt.marketwire.com/?release877449&id1512490&type1&urlhttp%3a%2f%2...))
is focused on the development of minimally invasive medical devices
for the treatment of glaucoma, the leading cause of adult irreversible
blindness. Over 4 million people in the U.S. and roughly 60 million
worldwide are afflicted with the disease today and the numbers are
expected to grow to nearly 6 million in the U.S. and over 70 million
worldwide by the year 2015.
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