The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients.
FDA clearance covers broad patient applicability, including growing children, teens and adults (with surgery or other techniques).
Align Technology unveiled the technology at its September Investor Day event. The palatal expander — Align’s first direct 3D-printed orthodontic device — provides a safe, comfortable and clinically effective alternative to metal palatal expanders. Those devices requires manually turning a screw in the device in the mouth daily to achieve expansion.
The expanders feature a series of removable devices staged in small increments of movement to expand a narrow maxilla. Each 3D-printed device is customized to a patient’s unique anatomy based on an iTero intraoral digital scan. Align Technology’s proprietary AI-driven orthodontic software then develops a treatment plan and device design.
Combined with Invisalign First aligners, the expanders give doctors a full early intervention treatment solution for Phase 1 treatment in orthodontics. The company says Phase 1 treatment makes up 20% of orthodontic case starts annually.
Align Technology offers the expander on a limited basis in Canada and the U.S. It expects availability in more markets next year.
“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,” said Dr. Mitra Derakhshan, SVP, global clinical. “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.”
