LENSAR® Receives FDA Clearances for Laser Cataract Platform Integration With OCULUS Pentacam® Tomographers
May 05 2017 - 4:31PM
Business Wire
Incorporating Popular Diagnostic Technology
Capabilities Expands LENSAR Laser System Potential Customer
Base
LENSAR, Inc., a global leader in next generation femtosecond
laser technology for refractive cataract surgery, today announced
it received 510(k) clearance for integration of the popular OCULUS
Pentacam® (both Pentacam® HR and Pentacam ®AXL) and ALADDIN
topographer from Topcon to the LENSAR® Laser System with
Streamline™ III. These latest approvals advance the advantages of
the LENSAR Laser System’s industry exclusive open architecture,
expanding the femtosecond refractive cataract platform’s appeal to
the extensive Pentacam user base and continuing to serve the needs
of refractive cataract surgeons and their patients.
“As always, our customers significantly influence the choices we
make about the devices selected for integration into the LENSAR
Laser System and there is simply no denying Pentacam is a strong
technology of choice in advanced cataract surgical planning,” said
Nicholas Curtis, CEO of LENSAR. “Our open architecture platform
allows surgeons to use the diagnostic devices they trust to guide
treatment and manage astigmatism using our laser’s exclusive
features to ultimately deliver the outcomes and experience today’s
patients demand from an advanced cataract procedure.”
Direct transfer of pre-operative evaluation and planning data
from topographers to the LENSAR Laser System via wireless or USB
helps reduce the stackable errors that contribute to suboptimal
outcomes. LENSAR leads the industry in its focus on helping
surgeons with astigmatism management in all cataract procedures
with its intuitive Streamline III features including:
- Integration of complete corneal
measurements, including total corneal refractive power and total
corneal astigmatism
- Iris Registration with automatic
cyclorotation adjustment
- IntelliAxis™ steep axis corneal
marking
- Arcuate incision planning leveraging
pre-programmed and updated surgeon data
- Surgeon tables used to manage
pre-existing and surgically induced astigmatism
“Patients undergoing cataract surgery have very high
expectations. The Pentacam is an effective preoperative diagnostic
technology that allows the clinician to evaluate the cornea and
anterior segment of the eye in high detail,” said William Trattler,
M.D. of the Center for Excellence in Eye Care. “Integrating the
Pentacam capabilities with the LENSAR platform provides a
tremendous advantage to the cataract surgeon who desires to meet
and exceed patient expectations.”
Pentacam and ALADDIN join the Cassini® Corneal Shape Analyzer
(i-Optics) and the Nidek ODP in the stable of topographers capable
of direct integration into the LENSAR Laser System, allowing
surgeons to optimize treatment for each individual patient based
upon complete corneal measurement data.
About the LENSAR Laser System with
Streamline III
The LENSAR Laser System with Streamline III, the third LENSAR
system upgrade in two years, is dedicated to helping surgeons
manage astigmatism with extreme treatment planning insights. The
only femtosecond cataract laser on the market today developed
specifically for refractive cataract surgery, the LENSAR Laser
System features quick and easy patient docking, as well as superior
imaging capabilities including LENSAR’s proprietary Augmented
Reality™ 3-D reconstruction. This technology facilitates enhanced
procedure outcomes by allowing the physician to develop
individualized treatment plans including precise laser delivery and
efficient lens fragmentation that can reduce, and potentially
eliminate, the amount of energy delivered into the eye.
About LENSAR, Inc.
LENSAR, Inc., is a global leader in next generation femtosecond
cataract laser technology for refractive cataract surgery. The
LENSAR Laser System with Streamline III offers cataract surgeons
automation and customization for their astigmatism treatment
planning and other essential steps of the refractive cataract
surgery procedure with the highest levels of precision, accuracy,
and efficiency. These features assist surgeons in managing
astigmatism treatment for optimal overall visual outcomes.
The LENSAR Laser System has been cleared by the U.S. Food and
Drug Administration for anterior capsulotomy, lens fragmentation,
and corneal and arcuate incisions. For other indications, it is an
investigational device limited by U.S. law to investigational use
only. For more information, please visit www.lensar.com.
About PDL BioPharma Inc.
PDL BioPharma (NASDAQ: PDLI) seeks to optimize its return on
investments so as to provide a significant return for its
shareholders by acquiring and managing a portfolio of companies,
products, royalty agreements and debt facilities in the biotech,
pharmaceutical and medical device industries. In late 2012, PDL
began providing alternative sources of capital through royalty
monetization and debt facilities and in 2016, began making equity
investments in commercial stage companies. PDL has committed over
$1.4 billion and funded approximately $1.1 billion in these
investments to date.
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version on businesswire.com: http://www.businesswire.com/news/home/20170505005852/en/
for LENSARLiana Miller,
949-276-8920liana@engagedcommunication.net
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