Home Industry Align Technology receives FDA approval for the Invisalign Palatal Expander System

Align Technology receives FDA approval for the Invisalign Palatal Expander System

Align Technology, a medical technology company that develops the Invisalign system for transparent aligners, iTero intraoral scanners and exocad CAD/CAM software for digital orthodontics and restorative dentistry, announced that the U. S. Food Drug Administration (FDA) has approved the Invisalign Palatal Expander System for commercial availability in the United States.

Speaking at the company’s 2023 Investor Day in Las Vegas, Srini Kaza, Align senior vice president of product research & development said, “I am very proud to unveil the Invisalign Palatal Expander System, our latest innovation in digital orthodontics based on proprietary and patented technology that builds on many industry firsts designed for treatment of children and teens, including Invisalign treatment with Mandibular Advancement and Invisalign First aligners. It is extremely rewarding for our team of engineers and material scientists to produce Align’s first directly fabricated orthodontic appliance and pave the way for future innovation using direct 3D printing technology that enables more sustainable and efficient solutions.”

The Invisalign Palatal Expander System comprises a series of removable appliances tailored to the patient’s individual anatomy based on an iTero intraoral scan. The treatment and appliance design is developed using Align’s AI-driven orthodontic software.

In combination with the Invisalign First aligners, the system offers comprehensive early intervention treatment for young patients. This represents an advance over traditional methods such as arch expanders or partial metal braces.

“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.”

The system is currently available on a limited scale in Canada and the US and is expected to be available in other markets from 2024, subject to regulatory approvals.

This development highlights the potential of 3D printing in medical technology and its ability to offer more personalized and efficient treatment options.

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