Align Technology Gains Updated Canadian License for Invisalign Palatal Expander System

Health Canada has issued an updated medical device license to Align Technology Inc. for its Invisalign Palatal Expander System.* The updated license is for broad patient applicability, including growing children, teenagers, and adults (with surgery or other techniques). 
 
Previously introduced last fall, the Invisalign Palatal Expander System is a 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. 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, according to the company.

“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.”
 
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 his or her 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 conducted 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 makes up 20 percent of orthodontic case starts each year and is growing,” stated 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 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. 

The Invisalign Palatal Expander System* is a 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. 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).
 
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 approximately 252,000 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 more than 16.4 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align Digital Platform, its integrated suite of proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. 

* 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 one patient age 6-11 years with IPE. Data on file at Align Technology Inc. as of Oct. 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 Oct. 30, 2023. 
*** Data on File at Align Technology as of June 2021.