Zephyr Sleep Technologies Inc has been granted 510(k) clearance from the US Food and Drug Administration (FDA) to begin selling the MATRx medical device system. The MATRx system will be used in sleep laboratories to identify patients who will be successful with oral appliance therapy while establishing the protrusive position of the lower mandible for effective therapy.
“The MATRx system changes the way oral appliance therapy is prescribed, bringing the knowledge and expertise of both sleep physicians and dentists into the therapy decision much earlier. This new technology will certainly change how things are done,” says Paul Cataford, Zephyr’s president and CEO.
A MATRx study is performed in a sleep laboratory by a sleep technician in conjunction with a sleep study. Using this new technology, sleep physicians will be able to reliably predict the effectiveness of oral appliance therapy as a treatment for obstructive sleep apnea patients, according to the company. This clears the way for sleep physicians to confidently prescribe oral appliance therapy in advance of patients being fitted with an oral appliance. MATRx also provides sleep dentists with an effective target protrusive position for the lower mandible.
This enables dentists to fit oral appliances with confidence in therapeutic outcome while eliminating the need for an iterative titration process. “Understanding a patient’s airway response to mandibular protrusion is a critical component of confidently prescribing and administering oral appliance therapy. The MATRx study offers many features that are comparable to and commensurate with the traditional CPAP study. In fact, the two studies can now work hand-in-hand to optimize sleep apnea management,” says Zephyr’s Chief Medical Officer, Dr John Remmers.
Zephyr signed an exclusive worldwide distribution agreement with SomnoMed, limited to market and sell this device under the name SomnoMed MATRx. SomnoMed is planning a limited US market release of MATRx to select hospitals and private clinics that will be the first to use the system, after which the MATRx will be available to a broader customer base and introduced in international markets.