Ark Surgical has secured FDA 510(k) clearance for LapBox POWER, positioning the company in the gynecologic surgical safety market. The tissue containment system is now FDA-cleared for use with both manual and power morcellation procedures.
Morcellation – a technique used to remove large tissue masses through small incisions during laparoscopic procedures – has presented safety challenges for gynecologic surgeons. This procedure is commonly performed during hysterectomies and myomectomies to remove the uterus or uterine fibroids through minimally invasive incisions rather than open surgery. Since 2014, the FDA has issued safety communications about the risks of uncontained morcellation, which can spread undiagnosed cancer cells or endometrial tissue.
“This new clearance validates what surgeons have already come to appreciate about LapBox – a reliable, intuitive system that raises the bar for safety without complicating the procedure,” said Stav Tori, CEO of Ark Surgical. “We are proud to deliver the only tissue containment solution cleared for both manual and power morcellation.”
The LapBox POWER features a “bag-in-a-bag” design. This dual-wall structure creates a barrier that helps prevent the dissemination of tissues during laparoscopic procedures. The system integrates into existing surgical workflows without adding complexity or extending procedure time.
Ark Surgical received initial FDA approval for the LapBox system for manual morcellation in 2023. The new clearance for power morcellation expands the technology’s applications, allowing surgeons to use the dual-wall system across more procedures. The development of LapBox involved collaboration with OB/GYNs to meet surgical needs while maintaining safety standards. This approach has resulted in a solution that addresses both safety and procedural efficiency.
According to the company, over 2.5 million gynecologic procedures are performed annually worldwide. Industry projections indicate the laparoscopic gynecology market will reach approximately $61 billion by 2034.
The LapBox POWER system aims to reduce the risk of complications associated with tissue dissemination during morcellation, including the spread of undiagnosed malignancies or the worsening of conditions like endometriosis or chronic pelvic pain. For healthcare facilities, the system provides an approach to containment that aligns with FDA recommendations. The design allows for integration into existing protocols.
