Align Technology Inc. Gains CE Mark for Innovative Invisalign Palatal Expander System

Align Technology Expands Innovative Offerings with CE Mark Approval for Palatal Expander System

Align Technology, Inc. continues to enhance its position in the orthodontics market with the recent announcement of receiving the CE Mark in Europe for its Invisalign® Palatal Expander System. This regulatory approval aligns with the company’s aim to innovate within the dental device sector by introducing advanced solutions that cater to a diverse patient base, including children, teens, and adults. The system is also registered with the MHRA for the UK and its overseas territories, broadening its reach and applicability across Europe.

The Invisalign Palatal Expander System represents a significant leap in digital orthodontic technology, utilizing direct 3D printing and iTero™ intraoral digital scans to create customized devices tailored to individual patient anatomies. This innovative approach allows for precise palatal expansion treatment plans developed through Align's proprietary software. Simon Beard, executive vice president and managing director of Align Technology for EMEA, underscores the company's commitment to transforming orthodontic treatment, positioning the Palatal Expander as a modern alternative to conventional methods. By integrating this system with its existing Invisalign First™ aligners, Align Technology offers a comprehensive early intervention treatment solution, particularly beneficial for young patients aged 6 to 10 who require Phase 1 treatment for various malocclusions.

Dr. Mitra Derakhshan highlights the increasing demand for Phase 1 treatments, which include the use of arch expanders and partial metal braces, noting that this segment accounts for 20 percent of annual orthodontic case starts. The introduction of the Invisalign Palatal Expander System not only enhances clinical outcomes but also improves operational efficiency within orthodontic practices. With its innovative capabilities and regulatory approvals, Align Technology is poised to address the growing needs of orthodontic patients effectively.

In addition to its technological advancements, Align Technology remains focused on its mission to provide accessible and effective orthodontic solutions. The CE Mark approval signifies not only compliance with European medical device regulations but also reinforces Align’s reputation as a leader in digital orthodontics. As the company continues to innovate and expand its product offerings, it aims to redefine patient experiences and outcomes in orthodontic care.

Overall, the launch of the Invisalign Palatal Expander System marks a pivotal development for Align Technology, aligning with ongoing trends toward more personalized and efficient orthodontic treatments. With the combination of advanced technology and a commitment to patient-centric solutions, Align is set to influence the future landscape of orthodontics significantly.