The US Food and Drug Administration grants De Novo FDA Clearance for the MATRx plus™ available for sale to the dental community in the United States through Dentsply Sirona, the dental product and technology manufacturer announced. The Simple Sleep Solution combines Dentsply Sirona 3D Imaging, MATRx plus, SICAT Air, and OPTISLEEP for a 3D solution for the analysis and treatment of obstructive sleep apnea (OSA).
The De Novo request for the MATRx plus is reportedly the “first ever at-home” class II medical device to identify patients suitable for oral appliance therapy. Said to be ideally suited for a dental office, the MATRx plus is a multifunction device capable of performing both: i) a standard home sleep test (HST); and ii) an oral appliance trial.
The MATRx plus’s tablet-based design is said to be easy-to-use with instructional videos walking patients through the self-administered test in the comfort of their own homes. Offering real-time, cloud connectivity, the MATRx plus simultaneously brings the patient’s study to the dental professional’s and the sleep physician’s office, and Zephyr’s servers allowing for instant collaboration among health professionals and responsive customer support. The MATRx plus technology uses proprietary algorithms, AI, and machine learning.
Dentsply Sirona 3D Imaging is led by the Orthophos SL 3D Ai and The Simple Sleep Solution rounds out a complete service offering from Dentsply Sirona which already includes digital solutions for implants and endodontics. Now every Orthophos SL 3D Ai system in the US will be bundled with The Simple Sleep Solution.
Using an oral appliance to treat OSA is not new; however, in the past, dental professionals and sleep physicians have been plagued with high treatment failure rates (30-40%) and arduous titration protocols and guesswork to determine a treatment position. This is now all changed. The MATRx plus tells the medical professional IF a patient can be treated (reducing the failure rate) and HOW to treat by offering a therapeutic treatment position. The dental professional uses this information to order and configure the oral appliance efficiently and effectively in a patient-friendly matter.
“Never before has providing a sleep appliance been so easy,” said Dr. Shouresh Charkhandeh, Zephyr’s Chief Dental Officer, an educator, and dental sleep medicine researcher.
Sleep-related breathing disorders, including OSA, affect as many as 25% of North American adults with most (over 85%) remaining undiagnosed and untreated.
“Finally, we are able to confidently prescribe an alternative therapy to CPAP and invasive surgery to treat OSA,” said Dr. John Remmers, Zephyr’s Chief Medical Officer. “Using The Simple Sleep Solution with the MATRx plus to responsibly and confidently select patients for oral appliances is the missing link to effectively treating a broader population.”
Dentsply Sirona and SICAT brought the first 3D solution for the airway analysis and appliance-based therapy for obstructive sleep apnea.
“The FDA clearance for the MATRx plus is a significant achievement for Zephyr Sleep Technologies, our partner in delivering the final piece for the first and only end-to-end 3D-solution for obstructive sleep apnea,” said Walter Petersohn, Dentsply Sirona’s Chief Commercial Officer.
US dentists will be able to learn more about integrating The Simple Sleep Solution for the very first time at Dentsply Sirona World, September 13, 2018, from clinicians who pioneered the technology and are instrumental to introducing this solution in the US.
OPTISLEEP is a two-piece appliance, offering patient comfort due to its slim design. The durable material and connector design are stable and enable both complete sealing of the lips and normal breathing, according to the company’s announcement. The exchangeable connectors come in 10 sizes that allow you to flexibly adjust the grade of protrusion. OPTISLEEP covers all teeth to avoid the elongation of individual teeth, and the continuous covering of the occlusal plane allows for a relaxed jaw position.
“The great visualization options of the software clearly facilitate our communication with the patient,” said Dr. Tarun Agarwal, DDS. “The advantages of an appliance-based treatment can be easily demonstrated. The slim design makes wearing OPTISLEEP very comfortable for patients and motivates them to start treatment.”
The Simple Sleep Solution is exclusively available with the purchase of the Orthophos SL 3D Ai. Visit: www.thesimplesleepsolution.com.