Chinese Regulators OK Invisalign Palatal Expander System for Skeletal, Dental Expansion

Align Technology Inc. has garnered China National Medical Products Administration (NMPA) approval of its Invisalign Palatal Expander System for skeletal and dental malocclusion in primary, mixed and permanent dentition. The product will be commercially available during second half of this year.

The Invisalign Palatal Expander System is a direct 3D-printed device based on proprietary and patented technology. Invisalign Palatal Expanders are used to rapidly expand and subsequently hold skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition in children or adolescents.

“The Invisalign Palatal Expander System exemplifies our commitment to advancing digital orthodontics with innovative solutions that enhance patient treatment experiences,” said David Carr, Align Technology executive vice president and managing director, Asia Pacific. “We are excited to extend the availability of the Invisalign Palatal Expander system, Align’s first direct 3D-printed orthodontic appliance, to even more doctors and their patients markets across the Asia Pacific region. Now with the NMPA approval, soon we will be able to also offer this innovation to our doctor customers in China.”

The Invisalign Palatal Expander System entails 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 customized 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 orthodontic software.

“With the upcoming availability of Invisalign Palatal Expander in China, I will soon be able to offer end-to-end comfortable early intervention solutions to my younger patients. Seeing the great clinical outcomes shared by my peers in other markets only heightens my enthusiasm for what this means for my patient care,” shared Dr. Cheng Hui, leader of Early Orthodontics at Keen Group, Shandong, China.

The Invisalign Palatal Expander System is intended to treat malocclusion. In adults, the system is used in conjunction with surgery or other interventions when necessary. The devices are 3D printed and manufactured based on digital scan data from commercially available iTero intraoral scanners. The expanders are removable for better oral hygiene;¹ and manufactured to custom fit each patient’s anatomy for optimal comfort and aesthetics. The expanders fit comfortably in a patient’s mouth and are changed daily (no screw required).

The System is comprised of Invisalign Palatal Expanders (active expansion, each stage comes with a programmed expansion of up to 0.25mm/stage, changed daily or as per doctor’s discretion) and Invisalign Palatal Holders (copies of the last stage ​of the expansion phase designed to hold the maxilla post-active expansion and changed every two to four weeks as directed by the treating doctor), Invisalign Attachment Templates and proprietary 3D shape generation software. These products are not available for purchase by the general public. However, the products are available for purchase from Invisalign trained dentists and orthodontists.

“With Invisalign Palatal Expander coming to China market soon, I will soon be able to offer complete early intervention solutions that focus on both effectiveness and comfort for children,” stated Dr. Yuan Gongjie of Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, China. “Learning about the great outcomes of this product from my peers in other markets gives me even greater confidence in the benefits this product can bring to my younger patients.”

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 conducted 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 accounts for 20% of orthodontic case starts each year and is growing,” commented Dr. Mitra Derakhshan, Align Technology executive vice president, Chief Clinical Officer, global Treatment Planning and Clinical Services. “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 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.”

Align Technology designs and manufactures the Invisalign System, a clear aligner system, iTero intraoral scanners and services, and exocad CAD/CAM software. Over the past 28 years, Align has helped doctors treat more than 20.1 million patients with the Invisalign System and is driving evolution in digital dentistry through the Align Digital Platform, an integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners.

The Invisalign Palatal Expander System is currently available in the United States, Canada, Brazil, Australia, New Zealand, Hong Kong, Singapore, the European Union, United Kingdom, UAE, Switzerland, Japan, Vietnam, Thailand and Turkey, and is expected to be available in additional markets, pending regulatory approvals.

Reference
¹ Based on the survey in August 2023 in CAN of 10 Invisalign trained orthodontists who participated in the Invisalign Palatal Expander System Technical Design Assessment and have treated at least one patient age 6-11 years with IPE, who responded to the question: “Please indicate your agreement with the following statement: Patients treated with the Invisalign Palatal Expander System experience better oral hygiene than those patients treated with traditional palatal expanders (such as Schwartz, Hyrax, etc.)” Agreement scale is one to four with one being “strongly disagree” and four being “strongly agree”. Data on file at Align Technology, as of Oct. 30, 2023.