- 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 the U.S. Food and Drug
Administration (FDA) has cleared Align’s Invisalign® Palatal
Expander System* for commercial availability in the U.S. The FDA
510(k) clearance is for broad patient applicability, including
growing children, teens, and adults (with surgery or other
techniques).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231218813291/en/
A young patient independently inserting
Invisalign® Palatal Expander- courtesy of Dr. David Walt, Vaughan,
Ontario, Canada
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.
Speaking at the company’s 2023 Investor Day in Las Vegas, Srini
Kaza, Align senior vice president of product research &
development said, “I am very proud to unveil the Invisalign Palatal
Expander System, our latest innovation in digital orthodontics
based on proprietary and patented technology that builds on many
industry firsts designed for treatment of children and teens,
including Invisalign treatment with Mandibular Advancement and
Invisalign First aligners. It is extremely rewarding for our team
of engineers and material scientists to produce Align’s first
directly fabricated orthodontic appliance and pave the way for
future innovation using direct 3D printing technology that enables
more sustainable and efficient solutions.”
The Invisalign Palatal Expanders 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***.
“The Invisalign® Palatal Expander System worked very well
clinically, we had fewer emergencies and less chair time than we
did with traditional expanders,” said Dr. Don Spillers, an
orthodontist in Warner Robins, Georgia and participant in an
Invisalign Palatal Expander clinical trial. “The experience has
definitely been much better for my patients with the Invisalign
Palatal Expander System, as there was no cementing of bands, no
fitting of a metal expander, and no screw to turn. All of the
parents were happy and their kids were cooperative.”
“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 available on a limited
basis in Canada and the U.S. 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, Inc. 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. The Invisalign Palatal
Expander System is indicated for the orthodontic treatment of
malocclusion. The system is used for the rapid expansion and
subsequent holding of skeletal and/or dental narrow maxilla (upper
jaw, dental arch and teeth, palate) with primary, mixed, or
permanent dentition during orthodontic or orthopedic treatment in
children or adolescents. In adults, it is to be used 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 up to
0.25mm/stage, changed daily or as per doctor’s discretion) and
Invisalign Palatal Holders (copies of the last stage of the
expansion phase designed to hold the maxilla post-active expansion
and changed every 2-4 weeks as directed by the treating doctor),
Invisalign Attachment Templates and proprietary 3D shape generation
software.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231218813291/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 11 2024 まで 12 2024
Align Technology (NASDAQ:ALGN)
過去 株価チャート
から 12 2023 まで 12 2024
