Align Technology, Inc. (NASDAQ: ALGN), a leading global medical device company focused on the development and sale of digital orthodontic and restorative dental products, announced that its revolutionary Invisalign? Palatal Expander System has been officially approved by the Malaysian Medical Device Authority as a Class B medical device.
This marks the full availability of the product in Malaysia for a wide range of patient populations, including children, adolescents and select adults who require surgical treatment.
Based on Align’s proprietary and patented technology, the Palatal Expander System uses modern 3D printing technology and is designed to expand the maxillary (i.e., upper jaw) structure during orthodontic treatment and provide fixed support when needed.
The device is suitable for patients in primary, mixed and permanent dentition and is Align’s first directly 3D printed orthodontic device.
“This innovation demonstrates our continued commitment to advancing digital orthodontic solutions,” said David Carr, Executive Vice President and Managing Director of Asia Pacific at Align Technology.
We are excited to bring this groundbreaking Invisalign Palatal Expander System to more markets in Asia Pacific, bringing a better treatment experience to doctors and patients.”
The Invisalign Palatal Expander System consists of a series of removable custom devices, each designed based on the patient’s oral structure captured by iTero? intraoral scans, combined with Align’s proprietary AI-driven orthodontic software to develop a treatment plan to gradually expand the patient’s maxilla to the doctor’s preset position.
The system can be used in conjunction with Align’s Invisalign First? aligners to provide doctors with a more complete Phase I early interceptive orthodontic treatment solution. Phase I treatment is mainly for young patients, by expanding the dental arches or correcting malocclusion before the permanent teeth are fully erupted (usually between 6 and 10 years old).
Invisalign First clear aligners are designed to address the specific needs of younger patients, such as shorter crowns, tooth eruption management, and predictable arch expansion.
Dr. Mitra Derakhshan, Executive Vice President and Chief Clinical Officer of Global Treatment Planning and Clinical Services at Align Technology, said: “Currently, Phase I treatment accounts for approximately 20% of orthodontic cases worldwide and continues to grow.
By combining Invisalign First clear aligners with the new palatal expander system, doctors can more effectively address common skeletal and dental misalignments that occur as children grow. At the same time, the addition of mandibular advancement also provides more treatment options for adolescent bite issues.”
Currently, the Invisalign palatal expander system has been successfully launched in multiple Asia Pacific markets, including Australia, New Zealand, Hong Kong, Singapore, Vietnam, Japan, Thailand, India and Malaysia, marking another major advancement in Align’s digital orthodontics.