The ColonRing is a medical device designed to help a patient's body heal after colon surgery and represents the first major advance in this area in more than 30 years.

Each year, more than 500,000 surgeries involving GI tract resection are performed in the United States. The current surgical standard for reconnecting the resected bowel involves surgical staples and stapling devices, which puncture tissue (more than 100 punctures), while creating an intermittent reconnection, and can also crush it. Hence, stapling hinders the natural healing process and the natural structure of the resected bowel, potentially resulting in adverse effects including bleeding. In addition, surgical staples leave permanent foreign material within the bowel lumen, and the bowel is often left with a reduced lumen size. The ColonRing with BioDynamix™ Anastomosis technology is a novel device intended to address the major drawbacks of circular staples. Because anastomosis (the surgical connection of two parts of a hollow organ) with the ColonRing is staple-free, there are no bowel wall punctures, no risk of staple line bleeding, and no permanent foreign bodies in the bowel.

"Current closure strategies for patients recovering from colon surgery most often involve the use of surgical staples and stapling devices, which can sometimes lead to leakage, inflammation and even infection, all of which negatively impact the healing process," stated Stephen M. Cohen MD, FACS, FASCRS, colon and rectal surgeon, Southern Regional Medical Center in Atlanta. "The staple-free ColonRing is an effective, simple-to-place device that applies gentle pressure to the resected colon until the sections completely and naturally grow back together, and is then expelled from the body. Based on my experience with the device, the ColonRing has the potential to reduce post-operative leaks and strictures while eliminating the staple line bleeding -- clinical benefits which can potentially translate into a shorter hospital stay for the patient, earlier return to natural body function, and overall cost savings to the healthcare system."

The safety and efficacy of the ColonRing device (also known as CAR™ 27) has been established in multiple clinical trials and in commercial use. The device has been used successfully throughout the bowel, from 4 cm to more than 50 cm from the anal verge and in a wide range of surgical procedures. The device received U.S. Food and Drug Administration (FDA) clearance and CE Marking in Europe for use in colorectal and gastrointestinal surgeries. An analysis of clinical data from 1,175 surgeries performed by 192 surgeons across 127 sites in the USA and overseas will be displayed by NiTi at the ASCRS meeting. This supporting analysis, plus case presentations by leading colorectal cancer investigators, will be exhibited at the meeting (Booth #805). NiTi continues to study the use of the ColonRing device in clinical trials, and is planning a Phase IV trial to provide further validation of the compelling results reported to date.

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