Claria Medical has secured De Novo classification and marketing authorisation from the US Food and Drug Administration (FDA) for its Claria system, which is designed to support tissue extraction during minimally invasive hysterectomy procedures.
The FDA reviewed the device under its Safer Technologies Program (STeP), which aims to accelerate assessment of medical technologies that are anticipated to improve safety compared to existing options.
This device features a uterine containment and extraction system designed for enhancing the speed and safety of hysterectomy procedures for surgeons and patients.
It employs SafeStop technology, which uses electronic communication between a tri-layer tissue container and handpiece to help manage and prevent unintended breaches of the safety barrier.
The system is intended to allow for a transvaginal approach to tissue extraction, which avoids mini-laparotomy, and features an ergonomic design for surgeons.
Regulatory submission for the device was supported by a multinational, prospective, controlled clinical study that showed positive safety and performance outcomes.
In this study, the median extraction time for large uteri was reported at four minutes.
Claria Medical said that surgeons in the trial achieved these results with minimal device training, and all participating surgeons gave favourable feedback.
Detailed clinical results are expected to be presented by Claria Medical later this year.
Claria Medical CEO Alexey Salamini said: “The safety risks associated with today’s standard of care are simply too high; women everywhere deserve a better, safer method for these vital surgical procedures.
“The FDA’s authorisation as part of the STeP programme supports the Claria System’s expected clinical benefit over currently available treatments and provides surgeons with a valuable new tool to address an urgent clinical need.
“Clearing this hurdle allows us to expedite our efforts to make this improved technology available to health systems, surgeons, and patients around the country.”
Claria Medical is supported by private and strategic investors and has received grants from the National Institutes of Health and the National Science Foundation.
The company has indicated its intention to establish commercial pilot sites with prominent healthcare systems in the US following FDA authorisation.
