The Valencia Technologies eCoin® is the first implantable tibial nerve stimulator approved by the FDA
The eCoin® is a minimally invasive coin-sized neurostimulation therapy for urge urinary incontinence.
The Valencia Technologies eCoin® is an FDA-approved, coin-sized implant for the treatment of urge urinary incontinence (UUI). Implanted in the patient’s ankle, this minimally invasive subcutaneous neuromodulation system (SNS) provides automatic stimulation to the tibial nerve, effectively relieving UUI symptoms.
Valencia Technologies approached Ingenuity with the challenge to enhance the eCoin® device with new functional modes and ensure compliance with regulatory standards. With a focus on improving patient safety and comfort during and after the implantation procedure, Ingenuity leveraged their expertise in embedded evaluation, development, and testing to successfully introduce a firmware update. This update incorporated enhanced configuration and power management controls, significantly optimizing the device’s performance. Ingenuity also provided essential software compliance guidance, playing a fundamental role in Valencia Technologies’ FDA submission process.
Ingenuity’s extensive experience in medical device development was vital to meeting the Valencia’s rigorous requirements. Through our robust software development process, we successfully developed the embedded software, meeting the new functional mode requirements. In addition, we meticulously updated and prepared the essential IEC 62304 documentation, covering various crucial aspects such as requirements, architectures, detailed designs, DFMEA, traceability matrix, usability reports, and verification protocols. The collaboration between Valencia Technologies and Ingenuity resulted in an advanced medical device that received FDA and TGA approval, enabling patients to live uninterrupted lives.
