FDA OKs Claria Medical’s Tissue Containment, Removal System for Hysterectomy

Claria Medical has received U.S. Food and Drug Administration (FDA) de novo classification and marketing authorization for its device to facilitate safe, efficient tissue extraction during minimally invasive hysterectomies.

The company said that about 30% of the 600,000 hysterectomy procedures done each year in the U.S. need special techniques and tools to extract the uterus, like a containment barrier to prevent tissue dissemination. The procedure can take up to an hour and a half with risk of bowel injury and containment breach.

Designed to boost hysterectomy speed and safety, the Claria system represents the first combined tissue containment and removal system to win an FDA nod. Claria’s SafeStop tech leverages electronic communication between its tri-layer container and handpiece to prevent safety barrier breaches, and its transvaginal approach allows extraction without a mini-laparotomy.

The system achieved a median extraction time of four minutes for large uteri in a clinical study. Surgeons reported positive feedback with minimal training, and the company expects to release detailed results later this year.

The Claria system was accepted into the Safer Technologies Program (STeP), an FDA program meant to expedite review for devices with the potential to significantly improve on current treatments. The company is backed by private and strategic investors, with several grants awarded from the National Science Foundation (NSF) and the National Institutes of Health (NIH).

“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,” Claria’s CEO Alexey Salamini told the press. “The FDA’s authorization as part of the STeP program 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.”