Therapeutic Device Reduces Postoperative Oxygen Desaturations

Peripheral stimulation technology reduces postoperative hypoxemia (oxygen desaturation) in patients at-risk for obstructive sleep apnea (OSA).

The MediPines (Orange County, CA, USA) Oxistimulator is a novel peripheral transcutaneous electrical stimulus (TES) device placed on the wrist that is designed to continuously monitor patient oxygenation levels and to reduce desaturations automatically when deemed necessary. Whenever threshold oxygen saturation (SpO₂) levels are lower than 93%, the Oxistimulator provides an immediate mild electrical stimulation, a therapeutic response that is just strong enough to reverse the deterioration, without harm or discomfort to the patient.

In a double-blind study conducted at the Mayo Clinic (Rochester, MN, USA), 106 post-operative patients undergoing elective surgery who were at medium to high risk for OSA were randomized to either active stimulus (53 patients) with the Oxistimulator, or to an inactive placebo device (53 patients) at the post-anesthesia care unit. The results showed that the Oxistimulator group experienced a shorter duration of SpO₂ lower than 90% than the control group, with no adverse events reported. The study was published in the November 2019 issue of the Canadian Journal of Anesthesia.

“Oxistimulator represents a breakthrough in the way that it empowers clinicians to automate their clinical response; faster response means that patients spend less time in the hypoxemia danger zone,” said Steve Lee, CEO of MediPines. “This is a novel solution to a serious clinical problem, and we are fortunate to be partnering with outstanding clinical partners to prove the clinical safety and efficacy as we bring this technology to market.”

Current pre-operative screening practices have been shown to miss nearly 50% of patients with OSA, who are at-risk for serious postoperative desaturation events that can lead to complications prolonging patient hospitalization, and in some cases, even death. Currently, the burden of catching and reducing hypoxemia after surgery falls on the clinical staff, such as nurses, who manually intervene when they see a desaturation; however, this manual process has been demonstrated to be sub-optimal.

Related Links:
MediPines
Mayo Clinic