The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes impair a patient’s ability to breathing through the upper airway and talk normally.
ProTip hopes to solve these problems with their new device. ProTip is a French medical device manufacturer developing an artificial larynx, and they recently reported success with the first human implant. In the procedure, a titanium tracheal ring is implanted. A few months later, a valve-based tube is installed through the patients mouth. This technology mimics the body’s natural functions more closely than tracheostomy tubes, and allows patients to breathe from their mouths and noses.
Clinical trials are now being conducted in Europe, prior to regulatory approvals. This alternative treatment could prove to improve quality of life and better patient outcomes, and I look forward to hearing more about this technology in the future.