Invisalign Palatal Expander System now available in AU and NZ

Align Technology has announced that its Invisalign Palatal Expander System has been included in the Australian Register of Therapeutic Goods (ARTG) and the New Zealand Web Assisted Notification of Devices Database (WAND) and is commercially available in both Australia and New Zealand. Align Technology also shared that the Invisalign Palatal Expander System is expected to be available in other APAC markets pending regulatory approvals starting in 2024.

Invisalign Palatal Expander System
(Image: Business Wire)

The ARTG and WAND entries for Invisalign Palatal Expender System cover broad patient applicability, including growing children, teens and adults, with surgery or other techniques.

The Invisalign Palatal Expander System is a direct 3D printed device based on proprietary and patented technology, intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla with primary, mixed, or permanent dentition during treatment of patients.

“The Invisalign Palatal Expander is an example of our continuous commitment to innovation by advancing digital orthodontics and delivering products with greater efficiency for doctors and provide better treatment experiences for patients and their parents,” said Raj Pudipeddi, Align Technology chief marketing officer, executive vice-president and managing director, Asia Pacific. “We are delighted to introduce the Invisalign Palatal Expander system, Align’s first directly fabricated orthodontic appliance, to the Asia Pacific region.”

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 customised 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*.

“Phase 1 or early interceptive treatment makes up 20 percent of orthodontic case starts each year and is growing,” said Dr Mitra Derakhshan, Align Technology 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.”

“We are excited to present the Invisalign Palatal Expander system, a significant advancement in the field of digital orthodontics, to our doctor customers in Australia and New Zealand,” said Jonathan Primmer, Align Technology vice-president and managing director for Australia and New Zealand. “With the increasing demand for orthodontic treatment among children and teenagers in Australia and New Zealand, the launch of the Invisalign Palatal Expander system allows us to offer a more comprehensive early interceptive treatment solution in conjunction with Invisalign First, alleviating the most complex challenges with palatal expansion while providing an exceptional patient experience that is both comfortable and supports proper oral hygiene.”

*Data on File at Align Technology, as of June 2021.

Related: Align Technology receives US FDA 510(K) clearance for the Invisalign Palatal Expander System