Covidien (NYSE: COV), a leading global provider of healthcare products, today announced published data demonstrating that the Company’s first powered surgical stapling system provides deeper access, better visibility and easier placement inside the low pelvis than a competing mechanical stapling device.
The results of the pre-clinical cadaver study1 directly comparing to the CONTOUR(R) Curved Cutter Stapler (Ethicon Endo-Surgery) are available online in the Annals of Surgical Innovation and Research.
“When performing colorectal surgery in the pelvis, it’s important to have the right tools to be able to divide the rectum as low as possible,” said lead author Toyooki Sonoda, MD, Associate Professor of Clinical Surgery at Weill Cornell Medical College and Associate Attending Surgeon at New York-Presbyterian Hospital/Weill Cornell Medical Center. “In some patients, this could potentially mean improved tumor clearance, or even the difference between having a permanent colostomy or not. This male cadaver study showed that we were able to reach deeper into the pelvis with better visualization using Covidien’s iDrive powered handle and RALC when compared to the CONTOUR Curved Cutter Stapler, a commonly used mechanical cutting and stapling device,” he said.
Dr. Sonoda noted, “These are important findings that could have positive implications for patient outcomes following colorectal surgery. We hope that further clinical studies confirm our findings in this study.”
The iDrive powered handle is a battery-powered, multi-patient, reusable handheld stapler and the RALC is a single-use reload, combining stapling and cutting functionality. When fired, the system deploys 32 titanium DST Series(TM) staples in two double-staggered rows and an integrated knife bisects the underlying tissue. With the push of a single button, the handle’s high-speed brushless motor delivers 4 rows of staples and cuts at an angle that is perpendicular to a curved shaft. This study shows that the stapler’s geometry may help gain deeper access to, and better visibility within, the pelvis during low anterior resections.
In the study, four surgeons performed pelvic dissections on 12 male cadavers. Males generally have smaller pelvises than females, which makes navigating surgical staplers more difficult during colorectal surgery.
The surgeons moved the rectum as they would when performing a total mesorectal excision. This technique, widely considered the clinical “gold standard” for treating colorectal cancer, involves removing a length of the bowel surrounding the tumor tissue. Surgeons then performed each dissection, using either the powered or mechanical stapling device, inserting the instruments as deeply as possible in the distal rectum in both the coronal and sagittal positions. The distance of the device from the pelvic floor was measured for each application. Then the surgeons rated the visibility and access of the two stapling devices.
The iDrive powered handle and RALC could be placed lower in the rectum than the Ethicon CONTOUR Curved Cutter Stapler in both the coronal and sagittal positions. The median distance of the stapler from the pelvic floor in the coronal position for the iDrive powered handle and RALC was 1.0 cm, compared to 2.0 cm for the CONTOUR (p=0.003).
In the sagittal position, the median distance from the pelvic floor was 1.6 cm for the iDrive powered handle and RALC and 3.3 cm for the CONTOUR (p<0.0001).
“These promising technical outcomes underscore Covidien’s commitment to developing innovative products that meet surgeons’ evolving needs and deliver improved outcomes for patients,” said Michael Tarnoff, MD, Chief Medical Officer, Covidien. “We believe that the iDrive powered handle and RALC system, our first powered surgical stapler, will continue to be well-received by surgeons and will enhance Covidien’s role in leading the emerging intelligent surgical tools category.”