iotaMotion, Inc, an early-stage medical technology startup, announced the successful completion of “the world’s first” two robotics-assisted cochlear implant insertions under an Abbreviated Investigational Device Exemption (IDE) using its iotaSOFT system, an investigational surgical tool currently in clinical evaluation at University of Iowa Hospitals & Clinics. This study is intended to gather confirmatory clinical evidence in support of the safety and performance of the investigational iotaSOFT system when used as a surgical support instrument during cochlear implant surgery with adults. These data will be used to support the company’s de novo premarket submission with the FDA.
The two cochlear implant procedures using the investigational device were performed by Bruce Gantz, MD.
“The precision, control, and consistency of robotics-assistance during insertion of an electrode array into the cochlea is highly desirable. The iotaSOFT system performed as I expected it would. I was able to incorporate the system appropriately with the standard steps of cochlear implant surgery,” said Gantz, professor of otolaryngology-head and neck surgery with University of Iowa Health Care.
The Company has developed technology that is designed to assist surgeons with the electrode array insertion phase of a cochlear implant procedure. The intent is to allow the surgeon to maintain a standard cochlear implant surgical approach and workflow, utilizing the robotic-assistance of the iotaSOFT system during electrode alignment and insertion. Notably, the surgeon controls the precise capabilities of the robotic-assisted insertion, while still using their technical skills, training, and experience.
“These first surgical procedures utilizing the iotaSOFT system are a critical step forward in merging precision robotic tools into the cochlear implant surgical workflow,“ said Christopher Kaufmann, President and CTO of iotaMotion. “We are grateful for Dr Gantz’s participation in the first clinical implementation of the system. We look forward to the continuation of this investigational study, and further development of important surgical assistive technologies in the cochlear implant space.”
Source: iotaMotion, Inc