First Excimer Platform Approved in Nearly
Two Decades Offers Accuracy, Efficiency and Usability
Advantages
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye
health company dedicated to helping people see better to live
better, today announced the U.S. Food and Drug Administration (FDA)
has approved the TENEO Excimer Laser Platform for laser-assisted in
situ keratomileusis (LASIK) vision correction surgery for myopia
and myopic astigmatism (nearsightedness and nearsightedness with
astigmatism)*.
“TENEO has been well received and is widely adopted in more than
50 countries around the world, and now U.S. ophthalmologists will
benefit from this versatile laser," said Luc Bonnefoy, president,
Global Surgical, Bausch + Lomb. “The precise engineering of this
platform delivers a fast, small, technologically advanced machine
that provides an exceptional experience for both surgeons and
patients.”
TENEO offers several unique features not offered by previous
excimer laser platforms.
Accuracy
The advanced eye-tracker operates at 1,740Hz, which is more than
three times the speed of the laser’s repetition. This feature helps
to ensure the laser ablation pattern is not negatively impacted by
a patient's eye movement and helps achieve outstanding
post-operative outcomes.
The platform’s high-speed laser operates at 500Hz, the fastest
ablation time of all excimer lasers available in the United States
at approximately 1.2 seconds per diopter.
Efficiency
The platform’s customizable graphical user interface touchscreen
simplifies set up and allows surgeons to access to the patient data
they choose without flipping through screens.
The cutting edge TENEO software treats the manifest refraction
and does not require a nomogram therefore streamlining surgical
planning by eliminating several steps prior to treatment. The
logical, intuitive process requires three steps: select patient;
choose and confirm treatment; treat.
In addition to these time saving advantages, the compact design
of the TENEO (0.6m2 (6.8 sq. ft)) makes it the smallest excimer
laser unit available in the United States, freeing up limited
clinical space, which is a critical concern for many surgeons.
Usability
TENEO has been specifically engineered for the comfort of both
surgeons and patients. It features a 360o swivelling microscope
that adapts to surgeon height and posture, aiding in surgeon
comfort.
The treatment bed comfortably accommodates patients of all
sizes, swings out for easier access, and can be customized for
optimal head positioning. The bed can be swivelled to be positioned
for a second treatment device† so that patients do not have to get
up and move, enhancing comfort and simplifying the surgical
process.
“FDA approval of TENEO represents a major milestone for the
advancement of laser vision correction technology in the United
States,” said George Waring IV, M.D., ophthalmologist and founder
and medical director, Waring Vision Institute, Mt. Pleasant, S.C.
“In addition to the technological advantages TENEO offers, the open
air feeling around the laser and quiet performance contribute to a
comfortable experience for the patient.”
For more information, visit
https://www.bauschsurgical.com/refractive/teneo/.
Indications and Important Safety Information for Technolas
Teneo 317 Model 2 System
Indications for Use. The Technolas Teneo 317 Model 2 is
indicated for laser-assisted in situ keratomileusis (LASIK) in: (1)
Patients for the reduction or elimination of myopic astigmatism up
to -10.00 D MRSE, with sphere between -1.00 D and cylinder between
0.00 and -3.00 D; (2) Patients who are 22 years of age or older;
(3) Patients must have a stable refraction in the last 12 months,
as documented by previous clinical recordings, i.e., the spherical
and cylindrical portions of the manifest distance refraction have
not progressed at a rate of more than 0.50 D per year prior to the
baseline examination in the eye(s) to be treated.
WARNING. Danger of injury due to failure to observe
the patient selection criteria! Failure to observe the
contraindications and potential adverse effects may result in
serious permanent patient injury. The usage of the laser system is
limited to a specific field of applications. Observe the
contraindications and potential adverse effects listed in the User
Manual before selecting a patient and starting any
treatment.
Contraindications. Contraindications of the Technolas
Teneo 317 Model 2 include patients: (1) with any type of active
connective tissue disease or autoimmune disease; (2) with signs of
keratoconus, abnormal corneal topography, and degenerations of the
structure of the cornea (including but not limited to pellucid
marginal degeneration); (3) with significant dry eyes (severe Dry
Eye Syndrome). If patients have severely dry eyes, LASIK may
increase the dryness. This may or may not go away. Severe eye
dryness may delay healing of the flap or interfere with the surface
of the eye after surgery. It may result in poor vision after LASIK;
(4) for whom the combination of their baseline corneal thickness
and the planned operative parameters for the LASIK procedure would
result in less than 250µ of residual corneal thickness from corneal
endothelium; (5) with uncontrolled diabetes; (6) with uncontrolled
glaucoma; (7) with active eye infections or active inflammation:
(8) with recent herpes eye infection or problems resulting from
past infections; (9) with known sensitivity to medications used for
standard LASIK surgery.
Potential Risks and Side Effects: (1) Miscreated flap;
(2) Subconjunctival hemorrhage or bleeding; (3) Wrinkles in flap
that may require a flap lift; (4) Corneal erosion/abrasion,
epithelia defect; (5) Elevated IOP; (6) Debris or foreign body
under flap; (7) Epithelial ingrowth under flap; (8) Debilitating
visual symptoms, especially at night; (9) Decreased or fluctuating
visual acuity; (10) Decreased ability to see in low-light
conditions; (11) Light sensitivity; (12) Dry Eye syndrome; (13)
Inadequate treatment result; (14) Regression; (15) Corneal damage;
(16) Posterior vitreous detachment or retinal detachment, floaters
or vascular accidents; (17) Foreign body sensation or pain (initial
postoperative days); also, potentially including chronic eye pain
that is resistant to therapy referred to as neuropathic pain; (19)
Infection/inflammation; (20) CTK (Central Toxic Keratopathy); (21)
Medication intolerance; (22) Ptosis; (23) Cataract; (24) Ocular
penetration; (25) Potential risk of psychological harm.
This is not all you need to know. Please see the User Manual
for a complete list of safety information, including a full list of
contraindications, warnings, precautions and risks.
Caution: Federal (U.S.) law restricts this device to sale, by
or on the order of a physician.
About LASIK Surgery
LASIK surgery is a common vision correction procedure for people
with myopia (nearsightedness), hyperopia (farsightedness) or
astigmatism.1 An alternative to wearing glasses or contact lenses,
the procedure involves using a special type of laser to change the
shape of the cornea.1 Around 10 million Americans have had LASIK
surgery since its approval in 1999 according to Marketscope.2
Approximately 550,000 LASIK surgeries are performed each year.2
About Myopia and Myopic Astigmatism
Myopia or nearsightedness is a common type of refractive error
where close objects appear clearly, but distant objects appear
blurry. According to the National Eye Institute, nearsightedness
affects about 25% Americans and is often diagnosed in children
between eight and 12 years of age and can worsen during the teen
years. Little change may occur between ages 20 to 40, but sometimes
nearsightedness can worsen with age. People whose parents are
nearsighted may be more likely to have the condition.3
Astigmatism happens when the cornea or lens has a different
shape than normal, making vision blurry.4 Astigmatism is common,
with about one in three people having some degree of the condition,
which happens along with myopia and hyperopia.5
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift
of sight for millions of people around the world – from the moment
of birth through every phase of life. Its comprehensive portfolio
of more than 400 products includes contact lenses, lens care
products, eye care products, ophthalmic pharmaceuticals,
over-the-counter products and ophthalmic surgical devices and
instruments. Founded in 1853, Bausch + Lomb has a significant
global research and development, manufacturing and commercial
footprint with approximately 13,000 employees and a presence in
nearly 100 countries. Bausch + Lomb is headquartered in Vaughan,
Ontario with corporate offices in Bridgewater, New Jersey. For more
information, visit www.bausch.com and connect with us on X,
LinkedIn, Facebook and Instagram.
Forward-looking Statements
This news release may contain forward-looking statements, which
may generally be identified by the use of the words “anticipates,”
“hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,”
“will,” “may,” “believes,” “estimates,” “potential,” “target,” or
“continue” and variations or similar expressions. These statements
are based upon the current expectations and beliefs of management
and are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risks and uncertainties discussed in
Bausch + Lomb’s filings with the U.S. Securities and Exchange
Commission and the Canadian Securities Administrators, which
factors are incorporated herein by reference. Readers are cautioned
not to place undue reliance on any of these forward-looking
statements. These forward-looking statements speak only as of the
date hereof. Bausch + Lomb undertakes no obligation to update any
of these forward-looking statements to reflect events or
circumstances after the date of this news release or to reflect
actual outcomes, unless required by law.
*Nearsightedness (myopia) between -1 and -10 diopters (D) with
astigmatism between 0 and -3 D.
† Depending on the bed design of the second device.
References
- Mayo Clinic Web site, About LASIK Surgery. Accessed Jan. 3,
2024.
https://www.mayoclinic.org/tests-procedures/lasik-eye-surgery/about/pac-20384774.
- WebMD: LASIK Surgery: Know the Rewards and Risks. Accessed Jan.
3, 2024.
https://www.webmd.com/eye-health/news/20180727/lasik-know-the-rewards-and-the-risks.
- National Eye Institute fact sheet on nearsightedness. Accessed
Jan. 3, 2024. Nearsightedness Fact Sheet (nih.gov).
- National Eye Institute: Astigmatism: At a Glance. Accessed Jan.
3, 2024.
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/astigmatism.
- Cleveland Clinic: Astigmatism. Accessed Jan. 3, 2024.
https://my.clevelandclinic.org/health/diseases/8576-astigmatism#:~:text=How%20common%20is%20astigmatism%3F,along%20with%20nearsightedness%20or%20farsightedness.
© 2024 Bausch + Lomb.
TEN.0016.USA.23
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240108249683/en/
Media: Kristy Marks kristy.marks@bausch.com (908)
927-0683
Investor: George Gadkowski george.gadkowski@bausch.com
(877) 354-3705 (toll free) (908) 927-0735
Bausch plus Lomb (NYSE:BLCO)
過去 株価チャート
から 12 2024 まで 1 2025
Bausch plus Lomb (NYSE:BLCO)
過去 株価チャート
から 1 2024 まで 1 2025
