mPulse
March 3, 2024

FDA Updates

Innovative Solution: The Inspire Upper Airway Stimulation System for Obstructive Sleep Apnea

The Inspire Upper Airway Stimulation (UAS) system is a cutting-edge solution for obstructive sleep apnea.

Including an implantable pulse generator, stimulation lead, and sensing lead, alongside external components like the physician programmer and patient remote, the system is designed to provide targeted nerve stimulation, maintaining an open airway during sleep.

The implantable pulse generator (IPG) monitors the patient’s breathing and delivers precise electrical impulses to stimulate the airway nerves. These impulses are customizable by the physician using the external

programmer. Meanwhile, the patient remote offers convenience, allowing individuals to activate or deactivate the treatment as needed.

This advanced system is specifically indicated for individuals aged 22 and older with moderate to severe obstructive sleep apnea who cannot use or tolerate traditional therapies like positive airway pressure (PAP) or bi-level positive airway pressure (BiPAP). It is also suitable for those without complete blockage or collapse of the soft palate.

Revolutionizing Treatment: The Minitouch 3.8 Era System for Heavy Menstrual Bleeding

The Minitouch 3.8 Era System represents a significant advancement in treating heavy menstrual bleeding.

This global endometrial ablation device is specifically designed for the ablation of the endometrial lining of the

uterus, offering a minimally invasive solution for menorrhagia caused by benign conditions in pre-menopausal women who do not desire future pregnancies.

Using the Minitouch 3.8 Era System involves the insertion of the device into the uterus, which may require cervical dilation by the healthcare provider. Once inserted, microwave energy generates heat, which will be applied briefly to destroy the uterine lining. The handpiece will be carefully removed after the heat wave is used, completing the procedure.

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