The Invisalign Palatal Expander System has also completed registration with the Medicines and Healthcare Products Regulatory Agency (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). Align said these approvals mark a significant milestone in its efforts to enhance clinical outcomes and efficiency in orthodontics.
The Invisalign Palatal Expander System is a modern direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during the treatment of patients.
Simon Beard, Align Technology executive vice president and managing director for Europe, Middle East and Africa (EMEA), said, “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.
“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 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 clinician. Each direct 3D printed device is customised to the patient’s unique anatomy using an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then developed using Align’s orthodontic software.
According to the company, 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 age six to 10.
Invisalign First clear aligners are designed to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion.
Mitra Derakhshan, executive vice president and chief clinical officer for Align Technology, said, “Phase 1 or early interceptive treatment accounts for 20 per cent of orthodontic case starts each year and is growing.
“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 Invisalign Palatal Expander System is expected to be commercially available in early 2025.