Xpan Inc., a leader in advancing minimally invasive surgical solutions, is excited to announce the successful FDA 510(k) clearance for its XpanTM Universal Trocar System and the completion of initial clinical procedures in the United States.
These achievements represent a major milestone in reshaping the standard of care for minimally invasive surgical access. The XpanTM system, featuring a patented radial expansion design, starts as a 3 mm port and can be dynamically dilated to 5 mm and/or 12 mm during the procedure, providing surgeons with adaptable options.
This distinctive technology minimizes tissue disruption and morbidity, enabling the use of state-of-the-art instruments and techniques with minimal invasiveness. With a potential impact on over 5 million abdominal and thoracic minimally invasive procedures in the U.S. alone, the XpanTM Universal Trocar System meets a crucial demand in the medical field. The development of this groundbreaking technology stems from collaborative efforts with visionary surgeons who identified the need for innovation in laparoscopic surgical access.
Source: https://www.businesswire.com/news/home/20231212064812/en/Xpan-secures-FDA-510-k-clearance-and-announces-successful-completion-of-initial-human-clinical-cases-in-the-United-States
