- Invisalign® Palatal Expanders offer doctors a removeable,
safe, and clinically effective alternative to traditional palatal
expanders.
- Combined with Invisalign First™ aligners, Invisalign Palatal
Expanders provide doctors with a full early intervention treatment
solution, including both skeletal (orthopedic) and dental
(orthodontic) arch expansion.
Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global
medical device company that designs, manufactures, and sells the
Invisalign® System of clear aligners, iTero™ intraoral scanners,
and exocad™ CAD/CAM software for digital orthodontics and
restorative dentistry, today announced that Health Canada issued an
updated medical device license to Align for its Invisalign® Palatal
Expander System*. The updated license is for broad patient
applicability, including growing children, teens, and adults (with
surgery or other techniques). The Invisalign Palatal Expander
System is available on a limited basis in Canada.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231213896980/en/
Dr. Sandra Tai’s patient independently
inserting Invisalign® Palatal Expander. (Photo: Business Wire)
Previously introduced at the Align Technology Investor Day in
September 2023, the Invisalign Palatal Expander System is a modern
and innovative direct 3D printed device based on proprietary and
patented technology. Invisalign Palatal Expanders are intended for
use in rapid expansion and subsequent holding of skeletal and/or
dental narrow maxilla (upper jaw) with primary, mixed, or permanent
dentition during treatment of patients. The Invisalign Palatal
Expander is Align’s first direct 3D printed orthodontic device and
provides a safe, comfortable, and clinically effective* alternative
to traditional palatal expanders that require manually turning a
screw in the device in the mouth daily to achieve expansion.
The Invisalign Palatal Expander System consists of a series of
removable devices staged in small increments of movement to expand
a patient’s narrow maxilla to a position determined by their
treating doctor.** Each direct 3D printed device is customized to
the patient’s unique anatomy based on an iTero™ intraoral digital
scan. A palatal expansion treatment plan and device design are then
developed using Align’s proprietary AI-driven orthodontic
software.
Combined with Invisalign First™ aligners, Invisalign Palatal
Expanders provide doctors with a full early intervention treatment
solution for Phase 1 treatment, an early interceptive orthodontic
treatment for young patients. Phase 1 treatment is traditionally
done through arch expanders or partial metal braces, before all
permanent teeth have erupted – typically at ages 6 through 10.
Invisalign First clear aligners are designed specifically to
address a broad range of younger patients’ malocclusions, including
shorter clinical crowns, management of erupting dentition, and
predictable dental arch expansion***.
“Many parents in my practice have found it challenging to
physically turn the screws on traditional palatal expanders,” said
Dr. David Walt, an orthodontist in Vaughan, Ontario and participant
in Align's Invisalign Palatal Expander System limited release
program in Canada. “The Invisalign Palatal Expander removes this
concern and creates a better overall experience for patients and
their parents. Beyond that, there have not been related emergency
visits, something that is more common with traditional palatal
expanders.”
“Phase 1 or early interceptive treatment makes up 20 percent of
orthodontic case starts each year and is growing,” said Dr. Mitra
Derakhshan, Align senior vice president, Global Clinical. “Together
with Invisalign First aligners, Invisalign Palatal Expanders
provide doctors with a solution set to treat the most common
skeletal and dental malocclusions in growing children. The addition
of mandibular advancement features to Invisalign aligners also
provides doctors with more options for treating skeletal and dental
jaw imbalances and bite correction for their growing patients
during their teenage years.”
“The Invisalign Palatal Expander System is a game changer, as it
alleviates the most common challenges with palatal expansion,
including maintaining proper hygiene, emergency appointments,
turning the screw, and the parents’ fear of causing pain to their
child in treatment,” said Dr. Sandra Tai, an orthodontist in
Vancouver and participant in Align's Invisalign Palatal Expander
System limited release program in Canada. “It’s removable and
supports oral hygiene while delivering a clinically effective and
comfortable treatment experience for growing patients that achieves
high satisfaction rates reported by parents.”
The Invisalign Palatal Expander System is pending pre-market
notification 510(k) clearance by the U.S. Food and Drug
Administration and is not yet available in the United States. It is
expected to be available in other markets pending regulatory
approvals starting in 2024.
*Based on a survey in August 2023 in Canada of 10 Invisalign
trained orthodontists who participated in the Invisalign Palatal
Expander System Technical Design Assessment and have treated at
least 1 patient age 6-11 years with IPE. Data on file at Align
Technology, Inc. as of October 30, 2023.
**Based on data from a multi-site US IDE (Investigational Device
Exemption) clinical study (n=29 subjects, ages 7-10 years) of
expansion treatment with Invisalign® Palatal Expanders. Data on
file at Align Technology, Inc. as of October 30, 2023
***Data on File at Align Technology, as of June 2021.
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign®
System, the most advanced clear aligner system in the world, iTero™
intraoral scanners and services, and exocad™ CAD/CAM software.
These technology building blocks enable enhanced digital
orthodontic and restorative workflows to improve patient outcomes
and practice efficiencies for approximately 252 thousand doctor
customers and are key to accessing Align’s 600 million consumer
market opportunity worldwide. Over the past 26 years, Align has
helped doctors treat over 16.4 million patients with the Invisalign
System and is driving the evolution in digital dentistry through
the Align Digital Platform™, our integrated suite of unique,
proprietary technologies and services delivered as a seamless,
end-to-end solution for patients and consumers, orthodontists and
GP dentists, and lab/partners. Visit www.aligntech.com for more
information.
For additional information about the Invisalign System or to
find an Invisalign doctor in your area, please visit
www.invisalign.com. For additional information about the iTero
digital scanning system, please visit www.itero.com. For additional
information about exocad dental CAD/CAM offerings and a list of
exocad reseller partners, please visit www.exocad.com.
Invisalign, iTero, exocad, Align, and Align Digital Platform are
trademarks of Align Technology, Inc.
About The Invisalign Palatal Expander System*
The Invisalign Palatal Expander System* is a modern, innovative
direct 3D printed orthodontic appliance designed based on
proprietary and patented technology. Invisalign Palatal Expanders
are intended for use in rapid expansion and subsequent holding of
skeletal and/or dental narrow maxilla (upper jaw, dental arch,
palate) with primary, mixed (primary and permanent), or permanent
dentition during interceptive treatment such as Phase 1 treatment
and orthodontic or orthopedic treatment in children, adolescents or
adults in conjunction with surgery or other interventions when
necessary. Devices are 3D printed and are manufactured based on
digital scan data from commercially available iTero® intraoral
scanners offered by Align Technology, Ltd. The devices are
removable and more hygienic than traditional appliances;
manufactured to custom fit each patient’s anatomy for optimal
comfort and aesthetics, expanders fit comfortably in the patient’s
mouth and changed daily (no screw required).
The System is comprised of Invisalign Palatal Expanders (active
expansion, each stage comes with a programmed expansion of
0.25mm/day, changed daily or as per doctor’s discretion) and
Invisalign Palatal Holders, (copy of the last stage of the
expansion designed to hold the maxilla post-active expansion phase,
changed every 2-4 weeks as directed by the treating doctor).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231213896980/en/
Align Technology, Inc. Madelyn Valente (909) 833-5839
mvalente@aligntech.com
Zeno Group Sarah Johnson (828) 551-4201
sarah.johnson@zenogroup.com
Align Technology (NASDAQ:ALGN)
過去 株価チャート
から 2 2025 まで 3 2025
Align Technology (NASDAQ:ALGN)
過去 株価チャート
から 3 2024 まで 3 2025
