Nine Continets Medical specialzies in implantable product development specifically implantable pacemakers, cardiac defibrillators and neurostimulator devices. In-house, on-staff specialties: include micro-power design, custom integrated circuit design, biomedical telemetry, component engineering, algorithm development, project management, verification and validation, dossier preparation for regulatory submission. The firm recently received Investigational Device Exemption (âIDEâ) from the U.S. Food and Drug Administration (âFDAâ) for this first human study of a novel medical device for patients with drug-resistant overactive bladder (âOABâ). The device is an implantable tibial nerve stimulator (âITNSâ¢â), a miniature, self-powered unit placed in the lower leg under local anesthesia. American Urological Association reports OAB affects approximately 40 million U.S. adults, or nearly one in six, and impacts men and women equally. An estimated 16 million Americans with OAB have no eff