Align Technology Receives US FDA 510(k) Clearance for the Invisalign Palatal Expander System to Address Skeletal and Dental Expansion in Growing Patients, Including Teenage Patients Which Represent the Majority of Orthodontic Case Starts Globally - Seite 2

The Invisalign Palatal Expanders 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 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 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***.

“The Invisalign Palatal Expander System worked very well clinically, we had fewer emergencies and less chair time than we did with traditional expanders,” said Dr. Don Spillers, an orthodontist in Warner Robins, Georgia and participant in an Invisalign Palatal Expander clinical trial. “The experience has definitely been much better for my patients with the Invisalign Palatal Expander System, as there was no cementing of bands, no fitting of a metal expander, and no screw to turn. All of the parents were happy and their kids were cooperative.”

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