Xpan secures FDA 510(k) clearance for flexible trocar system 

Canada-based company Xpan has received US Food and Drug Administration (FDA) 510(k) clearance for its universal trocar system. 

A trocar is a surgical instrument with a sharp point and tube and is used to withdraw fluid from the body in minimally invasive surgical procedures.  

Xpan’s universal trocar system starts as a 3mm port and can be expanded to 5mm or 12mm during the procedure, offering flexibility to surgeons. The radial dilation minimises tissue disruption compared to cutting. 

In the announcement accompanying the clearance, Xpan CEO Zaid Atto said: “Our goal is to provide patients and the healthcare system with a product that can reduce complications and provide superior post-operative outcomes.  

This technology was developed in collaboration with forward-thinking surgeons who recognize an opportunity and need for innovation in laparoscopic surgical access.” 

Xpan was founded in 2017 and received two US patents for the expandable trocar device in May 2023. In November 2022, the company received $30,000 as a finalist in the Dragon’s Den start-up pitch competition. Following this, an FDA-sponsored grant of $150,000 was awarded to the company from the National Capital Consortium for Pediatric Device Innovation. 

According to a GlobalData report, the US access instruments market is expected to be valued at $1.9bn in 2025, with $1.1bn of that revenue coming from trocar devices. 

Last month, German medical device company KARL STORZ SE was granted a patent for a passive holding device used during surgical operations to handle a trocar.

US-based company Caldera Medical’s trocar secured FDA approval in 2021 for urinary incontinence for women. The trocar, named the Desara TVez introducer, is available in two diameters, 2.7mm and 3mm, to insert the implant into the body. 

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• Source: https://www.medicaldevice-network.com/news/xpan-secures-fda-510k-clearance-for-flexible-trocar-system/