Xpan secures FDA 510(k) clearance and announces successful completion of initial human clinical cases in the United States

December 13, 2023 |

2 min read

Xpan Inc., a medical device company focused on minimally invasive surgical innovation, is proud to announce 510(k) clearance from the U.S. Food & Drug Administration for the XpanTM Universal Trocar System, and successful completion of initial clinical procedures in the United States.

The Xpan^TM Universal Trocar System is a first of its kind, radially expanding trocar that can be tailored by surgeons during laparoscopic procedures to accommodate 3 mm up to 12 mm instruments

TORONTO--(BUSINESS WIRE)-- Xpan Inc., a medical device company focused on minimally invasive surgical innovation, is proud to announce 510(k) clearance from the U.S. Food & Drug Administration for the Xpan^TMUniversal Trocar System, and successful completion of initial clinical procedures in the United States.

The FDA clearance and initial cases are significant milestones in the company’s journey to transform the standard of care for minimally invasive surgical access. Xpan is excited to bring its innovative technology to the U.S. market and looks forward to improving the quality of care for patients.

The Xpan^TM Universal Trocar System is a unique, patented radially expandable access device that initially enters the body as a 3 mm port which can subsequently be dilated intra-procedurally to 5 mm and/or 12 mm at the surgeon’s discretion as required by the demands of the procedure. The product allows surgeons to utilize the most minimally invasive instruments and techniques while minimizing patient tissue disruption and morbidity via radial dilation versus cutting of the tissue when surgeons require larger instruments in critical situations. It is estimated there are more than 5 million abdominal and thoracic minimally invasive procedures in the United States alone that can benefit from the Xpan’s Universal Trocar System.

“Our goal is to provide patients and the healthcare system with a product that can reduce complications and provide superior post-operative outcomes,” said Zaid Atto, CEO of Xpan. “This technology was developed in collaboration with forward thinking surgeons who recognize an opportunity and need for innovation in laparoscopic surgical access.”

Over the next few months, Xpan will continue to collect clinician feedback in support of its value proposition, prior to broader commercial release of its technology.

About Xpan Inc.

Xpan Inc. is a privately held company focused on design, manufacture, and marketing of minimally invasive surgical access devices. The Xpan^TM Universal Trocar System has 510(k) clearance from the U.S. Food and Drug Administration.

For more information, visit www.xpanmedical.com