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Invisalign® Palatal Expanders offer doctors a removable, safe and clinically effective alternative to traditional palatal expanders.
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Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with a comprehensive early intervention treatment solution that includes both skeletal (orthopaedic) and dental (orthodontic) arch expansion.
SAN JOSE, Calif. & TEMPE, Ariz., Dec. 18, 2023–(BUSINESS WIRE)–Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures and sells Invisalign® System of clear aligners, iTero™ intraoral scanners and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, announced today that the US Food and Drug Administration (FDA) has approved Align’s Invisalign® Palatal Expander System* for commercial availability in the US FDA 510(k) clearance is intended for broad application to patients, including developing children, adolescents, and adults (by surgery or other techniques).
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A young patient independently inserting the Invisalign® Palatal Expander- courtesy of Dr. David Walt, Vaughan, Ontario, Canada
The Invisalign Palatal Expander System, previously presented at the Align Technology Investor Day in September 2023, is a modern and innovative direct 3D printing device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in the rapid expansion and subsequent retention of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed or permanent dentures during patient treatment. The Invisalign Palatal Expander is Align’s first direct 3D printed orthodontic appliance and provides a safe, comfortable and clinically effective* alternative to traditional palatal expanders that require manual rotation of a screw on the appliance in the mouth daily to achieve expansion .
Speaking at the company’s 2023 Investor Day in Las Vegas, Srini Kaza, Align’s senior vice president of research and product development said, “I am very proud to unveil the Invisalign Palatal Expander System, our latest innovation in digital orthodontics based on our proprietary and patented technology that underpins many industry initiatives designed to treat children and adolescents, including Invisalign treatment with Mandibular Advancement and Invisalign First aligners. It is extremely rewarding for our team of engineers and materials scientists to produce Align’s first directly manufactured orthodontic appliance and pave the way for future innovation using direct 3D printing technology that enables more sustainable and efficient solutions.”
Invisalign Palatal Expanders consist of a series of removable appliances that are placed in small increments of motion to expand a patient’s narrow upper jaw to a position determined by their treating physician. ™ intraoral digital scan. A palatal expansion treatment plan and appliance design is then developed using Align’s proprietary artificial intelligence-based orthodontic software.
Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with a complete early intervention treatment solution for Phase 1 treatment, an early preventive orthodontic treatment for young patients. Phase 1 treatment is traditionally done through arch expanders or partial metal braces, before all permanent teeth have erupted – usually at ages 6 to 10. Invisalign First clear aligners are specifically designed to address a wide range of abnormalities in younger patients, including smaller clinical crowns, management of eruption and predictable expansion of the dental arch***.
“Invisalign® The Palatal Expander System worked very well clinically, we had fewer emergencies and less guidance time than with traditional expanders,” said Dr. Don Spillers, an orthodontist in Warner Robins, Georgia, and an Invisalign Palatal Expander clinical trial participant. “The experience was definitely much better for my patients with the Invisalign Palatal Expander System, as there was no cementing of the bands, no placement of a metal expander, and no screws to turn. All the parents were happy and their children cooperated.”
“Phase 1 or early preventive treatment makes up 20 percent of orthodontic cases started each year and growing,” said Dr. Mitra Derakhshan, Align senior vice president, Global Clinical. “Along with Invisalign First aligners, Invisalign Palatal Expanders provide doctors with a range of solutions to treat the most common skeletal and dental abnormalities in growing children. The addition of mandibular development features to Invisalign aligners also gives doctors more options for treatment of skeletal and dental jaw imbalances and bite correction for their growing patients during their adolescence”.
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 beginning in 2024.
*Based on an August 2023 survey in Canada of 10 Invisalign trained orthodontists who participated in the technical design evaluation of the Invisalign Palatal Expander System and have treated at least 1 patient aged 6-11 years with IPE. Data on file at Align Technology, Inc. from 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 Invisalign extension treatment® Palatal Expanders. Data on file at Align Technology, Inc. from October 30, 2023
***Data on file at Align Technology, Inc. from June 2021.
About Align Technology, Inc.
Align Technology designs and manufactures Invisalign® System, the world’s most advanced clear alignment system, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable improved digital orthodontic and restorative workflows to improve patient outcomes and practice efficiency for approximately 252,000 physician customers and are key to accessing Align’s 600 million consumer market opportunities worldwide. Over the past 26 years, Align has helped doctors treat more than 16.4 million patients with the Invisalign system and is leading the evolution in digital dentistry through the Align Digital Platform™, the comprehensive suite of unique, proprietary technologies and services provided as seamless, end-to-end solution for patients and consumers, orthodontists and general 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, visit www.invisalign.com. For more information on the iTero digital scanning system, visit www.itero.com. For additional information on exocad dental CAD/CAM offerings and a list of exocad reseller partners, 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 exclusive and patented technology. The Invisalign Palatal Expander System is indicated for the orthodontic treatment of the anomaly. The system is used for rapid expansion and subsequent retention of skeletal and/or dental narrow maxilla (maxilla, dental arch and teeth, palate) with primary, mixed or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, it should be used in conjunction with surgery or other interventions when necessary. . The appliances are 3D printed and manufactured based on digital scan data from commercially available iTero® intraoral scanners offered by Align Technology, Ltd. The appliances are removable and more hygienic than traditional appliances. Engineered to custom fit each patient’s anatomy for optimal comfort and aesthetics, the expanders fit comfortably in the patient’s mouth and are changed daily (no screw required).
The system consists of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of up to 0.25mm/stage, changes daily or at the doctor’s discretion) and Invisalign Palatal Holders (replicas of the last stage of the expansion phase Designed to hold the post-operative maxillary extension and changes every 2-4 weeks as directed by the attending physician), Invisalign Attachment Templates and proprietary 3D shape creation software.
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Contacts
Align Technology, Inc.
Madelyn Valente
(909) 833-5839
mvalente@aligntech.com
The Zeno Group
Sarah Johnson
(828) 551-4201
sarah.johnson@zenogroup.com
