TORONTO & TEMPE, Ariz.– 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.
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.”
