Surgical Robotics Technology
Global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, Apollo Endosurgery, has announced the publication of a multi-center study of the X-Tack® System in closing challenging gastrointestinal defects.
Removal of gastrointestinal lesions is one of the most common procedures in endoscopy and may result in defects which can lead to perforation or bleeding if not closed properly. Prevailing devices such as through-the-scope (TTS) clips or over-the-scope (OTS) clips often cannot effectively close large, wide, irregular, and difficult to reach defects. This study aimed to assess the feasibility and safety performance of the X-Tack System to address these limitations.
The multicenter study included ninety-three subjects who were treated at eight centers in the United States, including the Mayo Clinic, Johns Hopkins Hospital, Brigham and Women’s Hospital, and New York University, among others. The study focused on large, challenging defects in both the upper and lower GI tract, specifically those that would be difficult or impossible to close with alternative devices. The primary outcomes were feasibility (defined by technical success of the procedure) and safety.
- Mean defect size was 37mm ± 20mm
- Technical success was achieved in 89.2% of patients.
- 68% of defects were closed with a single X-Tack device. 18% of defects were closed with two and 12% were closed with three or four X-Tack devices.
- In 25% of cases X-Tack was used in combination with another closure device. All of these cases were done at just one of the eight centers.
- The investigators indicated that 24.7% of patients had defects that could not have been successfully closed using through-the-scope clips or over-the-scope clips.
- No serious adverse events occurred
Dr. Andrew Storm, co-director of the Mayo Clinic Developmental Endoscopy Unit and an investigator in the study commented, “The outcomes of this study support our ongoing, daily use of X-Tack. It allows us to close challenging resection sites, and it may cut down on costs associated with performing these highest quality, safest possible, polyp removal procedures.”
“We believe X-Tack has the potential to be play a significant role in improving GI defect closure. The findings from this multicenter study demonstrate X-Tack’s capability to reach and close GI defects, underscoring the device’s strong clinical and economic value,” said Chas McKhann, President and CEO of Apollo Endosurgery.
Source: Apollo Endosurgery.
