- Invisalign® Palatal Expanders offer doctors a removeable,
safe, and clinically effective alternative to traditional palatal
expanders.
- With Invisalign First™ aligners and Invisalign® Palatal
Expanders, Align Technology now provides doctors with a full early
intervention treatment solution, including both skeletal
(orthopedic) and dental (orthodontic) arch expansion.
- The Invisalign Palatal Expander System has also completed
registration with the United Kingdom Medicines and Healthcare
products Regulatory Agency (MHRA).
- Both approvals are for broad patient applicability,
including growing children, teens, and adults (with surgery or
other techniques).
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 it has received CE Mark
in Europe under the Medical Device Regulation (MDR 2017/745) for
Align’s Invisalign® Palatal Expander System. The Invisalign Palatal
Expander System has also completed registration with MHRA for the
United Kingdom and overseas territories.
Both approvals are for broad patient applicability, including
growing children, teens, and adults (with surgery or other
techniques).
These approvals mark a significant milestone in Align’s efforts
to enhance clinical outcomes and efficiency in orthodontics.
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 an example of Align’s
continuous commitment to innovative digital orthodontics by
delivering products with greater efficiency for doctors and better
treatment experiences for young patients,” said Simon Beard, Align
Technology executive vice president and managing director, Europe,
Middle East and Africa (EMEA). “We are thrilled to extend the
availability of this transformative alternative to traditional
palatal expanders to doctors and their patients across the EMEA
region.”
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 orthodontic software.
With Invisalign First™ aligners and Invisalign Palatal
Expanders, Align Technology can 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.
“Phase 1 or early interceptive treatment accounts for 20 percent
of orthodontic case starts each year and is growing,” said Dr.
Mitra Derakhshan, Align Technology executive vice president, chief
clinical officer. “Together with Invisalign First aligners,
Invisalign Palatal Expanders enables Align Technology to 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 expected to be
commercially available across EMEA in Q1 2025.
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign®
System, 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 over 271 thousand doctor customers
and is key to accessing Align’s 600 million consumer market
opportunity worldwide. Over the past 27 years, Align has helped
doctors treat approximately 18.9 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 intended 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 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 for better oral
hygiene1; manufactured to custom fit each patient’s anatomy for
optimal comfort and aesthetics, expanders fit comfortably in the
patient’s mouth and are 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. These products are not available for purchase by the
general public. However, the products are available for purchase
from Invisalign® trained dentists and orthodontists.
The Invisalign Palatal Expander System is currently available in
the U.S., Canada, Australia, New Zealand, Hong Kong, and Singapore,
and is expected to be available in additional markets, pending
regulatory approvals. The Invisalign Palatal Expander System is
expected to be commercially available across EMEA in Q1 2025.
1Based on the survey in August 2023 in CAN 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, who responded to the
question: “Please indicate your agreement with the following
statement: Patients treated with the Invisalign® Palatal Expander
System experience better oral hygiene than those patients treated
with traditional palatal expanders (such as Schwartz, Hyrax,
etc.)”. Agreement scale is 1-4 with 1 being “strongly disagree” and
4 being “strongly agree”. Data on file at Align Technology, as of
October 30, 2023.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241120527144/en/
Align Technology, Inc. Madelyn Valente (909) 833-5839
mvalente@aligntech.com
Zeno Group Sarah Johnson (828) 551-4201
sarah.johnson@zenogroup.com
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