MORRISVILLE, N.C.--(
BUSINESS
WIRE)--
TearScience, Inc., a privately-held medical device company,
today announced that it has received U.S. Food and Drug Administration (FDA)
clearance for its next generation product of its LipiFlow® Thermal Pulsation
System, a medical device that treats evaporative dry eye by liquefying and
evacuating obstructions in meibomian glands located in the eyelids. The second
generation product includes a more robust graphical user interface and provides
the ability for physicians to treat both of a patient’s eyes simultaneously.
The new LipiFlow® console incorporates an enhanced graphical user
interface by controlling pressure and displaying the treatment temperature,
pressure sequence and treatment time remaining. The new LipiFlow® also allows
physicians to store a record of the treatment on the device and on electronic
medical record servers, eliminating the need to manually document the treatment
in patient records. LipiFlow®’s second generation product also allows
physicians to treat two eyes simultaneously. Time savings achieved by
performing a bilateral treatment is beneficial for both busy physicians and
patients alike.
“We are pleased to have received FDA clearance for the
second generation LipiFlow® to offer to our current and future customers,” said
Tim Willis, chief executive officer and co-founder of
TearScience. “The improvements in this next generation LipiFlow® reflect
TearScience’s commitment to innovation. TearScience expects to provide many
more enhancements that will assist physicians in treating dry eye sufferers
efficiently, effectively and profitably.”
TearScience’s second generation LipiFlow® product will be
commercially available in March 2012. Physicians currently using TearScience’s
first generation LipiFlow® will be upgraded to the new system.
TearScience sells its LipiFlow® and LipiView® Ocular Surface Interferometer devices as a system
for eye care practices. The LipiView® enables physicians to visualize the eye’s
tear film. LipiView® won the 2011 Medical Design Excellence Award.
About TearScience, Inc.
Headquartered in Morrisville,
North Carolina, TearScience has
pioneered devices that provide significant clinical improvement in the
treatment of evaporative dry eye. Of the more than 100 million dry eye
sufferers worldwide, approximately 80 percent have evaporative dry eye, which
is caused by meibomian gland dysfunction (MGD) and a lipid deficiency of the
eye’s natural tear film. The Tear Film and Ocular Surface Society (TFOS) workshop, involving two years of work by 50 leading
experts from around the world, concluded that MGD is an under-estimated
condition and is very likely the most frequent cause of dry eye disease. Common
symptoms of the disease include eye irritation, dryness,
redness, tiredness, and visual disturbances. TearScience’s integrated,
in-office system enables eye care professionals to effectively address a root
cause of evaporative dry eye, obstructed meibomian glands. For additional
information, visit www.tearscience.com.
Posted by Sean Fenske, Editor-in-Chief, MDT