SAN JOSE, Calif., US: Align Technology has obtained CE marking in Europe and registration with the Medicines and Healthcare products Regulatory Agency in the UK for its Invisalign Palatal Expander System. Approved for use in young children, teens and adults, the 3D-printed device provides dentists and orthodontists with an innovative solution for treating the most common skeletal and dental malocclusions. Align aims to begin marketing the 3D-printed device in European and UK dental markets in the first quarter of this year.
Align explained in a press release that the system consists of removable 3D-printed devices that are customised to the unique anatomy of the patient and used to incrementally expand the maxilla to the desired position. Beginning with a digital scan using the company’s iTero intra-oral scanner, treatment with the system is planned via Align’s orthodontic software and is intended for both skeletal (orthopaedic) and dental (orthodontic) arch expansion in primary, permanent or mixed dentition.
The 3D-printed device, approved for use in young children, teenagers, and adults, provides dentists and orthodontists with an innovative solution for treating the most common skeletal and dental malocclusions.
Emphasising the advantages of the system in the treatment of young patients, the company said that its use with Invisalign First aligners provides dentists with a full solution for early intervention in Phase 1 orthodontic treatment. “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,” Align explained.
Dr Mitra Derakhshan, the company’s executive vice president and chief clinical officer, said that the use of early interceptive treatment is growing and already accounts for 20% of orthodontic case starts. “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,” Dr Derakhshan commented.
Align CEO Joseph Hogan told investors in the company’s third-quarter 2024 earnings call that the company was excited to extend the commercial availability of its first direct 3D-printed orthodontic appliance. In 2024, the Palatal Expander System was launched in Australia, New Zealand, Hong Kong and Singapore.
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