LapBox POWER, a revolutionary tissue containment system (TCS) designed for use with power morcellators in minimally invasive gynaecologic surgery, has been approved by the FDA 510(k) for use by Ark Surgical, a medical device pioneer focused on women’s health. With this additional indication, LapBox® becomes the first and only FDA-approved dual-wall containment device for both manual and power tissue extraction, building on the company’s 2023 certification for manual morcellation.
LapBox®, which was created in partnership with top OB/GYNs, has an easy-to-use “bag-in-a-bag” design that creates a spill-proof barrier, preventing the spread of endometrial cells, undetected cancer, and other potentially dangerous tissues during laparoscopic procedures. The TCS system doesn’t take more time or add complexity to surgical workflows.
“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.”
In gynaecologic surgery, morcellation is a commonly used method that involves making tiny incisions to remove big tissue masses, such as fibroids or the uterus. However, there are hazards associated with uncontained morcellation, such as the growth of undetected cancers or endometrial cells that could exacerbate diseases like endometriosis or persistent pelvic pain. The FDA responded by issuing many safety communications starting in 2014 and has since encouraged surgeons to employ containment devices that have received FDA clearance.
There has never been a greater demand for efficient, surgeon-friendly solutions, since the laparoscopic GYN industry is expected to reach $61 billion by 2034 and over 2.5 million gynaecologic procedures are performed annually worldwide.
LapBox® responds to that demand by facilitating safer, more intelligent procedures that are advantageous to both patients and healthcare professionals.
About Ark Surgical
Ark Surgical is a women’s health-focused medtech company developing advanced tissue containment solutions for minimally invasive gynecologic surgery. Its flagship product, LapBox®, is the first and only FDA-cleared dual-wall system for both manual and power morcellation.
