ColonRing™ with BioDynamix™ Anastomosis Technology
Clinical Results

Company Data from over 8,000 Cases Using a Novel Anastomosis Device

Background

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 sutures and stapling devices. Suturing and stapling hinder the natural structure of the reconnected bowel. Surgical stapling devices may disrupt the anastomosis while being withdrawn through the newly created anastomosis. In addition, surgical staples leave permanent foreign material within the body, and the bowel is often left with a reduced lumen size.

The ColonRing™ with BioDynamix™ Anastomosis technology from NiTi™ Surgical Solutions is a novel device designed to address the major drawbacks of circular staples. Because anastomosis with the ColonRing™ is not performed with staples, there are no through bowel wall punctures, no risk of staple line bleeding, and no permanent foreign body inside the bowel lumen. In pre-clinical trials, ColonRing™ resulted in a time zero anastomotic burst strength up to three times stronger than circular staplers. Anastomosis with ColonRing™ was seamless, with no anastomotic lip and a full circumferential, hemostatic seal.

The ColonRing™ consists of a ring with Nitinol leaf springs and an applier similar to that used with standard surgical circular staples. Nitinol is an advanced metal alloy that exhibits “shape memory,” the ability to return to its original shape after being deformed. Nitinol can be elastically deformed far more (up to 8%) than any regular metal (up to 0.5%), and applies a consistent force range as it returns to its original shape. In the ColonRing™, the Nitinol leaf springs stretch to open the ring for placement in the bowel, then return to their original closed position, applying a consistent force range at all points on the tissue. The ColonRing™ keeps adapting to variations in tissue thickness, causing the tissue to become necrotic. At the same time, the natural healing process generates healthy tissue along the ring’s outer perimeter. The necrotic tissue and the ring are expected to detach within one month, and safely pass through the digestive tract.

The safety and efficacy of the ColonRing™ have been demonstrated in several pre-clinical and clinical trials and in commercial use. The device has been used successfully throughout the colon, from less than 1 cm to more than 50 cm from the anal verge.

The purpose of this document is to compile the data on ColonRing™ to date, and to develop a robust understanding of its performance in varied clinical situations.

Methods

The ColonRing™ data presented here was collected from both clinical studies and commercial use of the device in over 8,000(1) patients by more than 600 surgeons at 375 sites in North America, Europe and Asia.
Sites ranged from major university medical centers to community-based hospitals. There is not data for every data point presented in this document. Averages represent averages of all data received for a given data point.

Patients were 56% female and 44% male. Average age was 62.4 ± 13.5, with a range of 14 to 91. Average BMI was 28.1 ± 6.2, with a range of 16 to 55.

Procedures were 7% right hemicolectomy, 48% left hemicolectomy, and 45% anterior resection. Of these, 50% were performed laparoscopically and 50% were open. Out of over 3,500 AR procedures performed, more than 450 involved chemo-radiated patients.

Results

The parameters presented below are independent of distance from the anal verge, as well as patient characteristics (e.g., age, sex, and BMI).

 

 

In all 7,641 commercial cases covered in this document,  a clinical leakage rate of 3.0% (228 cases) was reported.

Ease of Use

ColonRing™ is deployed with a device very similar to that used for circular staplers, designed to ease the surgeon’s adoption of the technology. The majority of surgeons rated it easy to use in all cases. Unlike stapling devices, the ColonRing™ anvil is not withdrawn through the newly created anastomosis, minimizing the potential for disruption of the anastomotic site.

 

Anastomotic Line

Surgeons performed post-surgical colonoscopies at their discretion. In most cases, surgeons reported a natural and seamless anastomosis with minimal or no visible scarring, and wide and open lumen.

End-to-end (left) and end-to-side (right) anastomoses 3 months post surgery.
Both images show a natural and seamless anastomosis with minimal or no visible scarring, and wide and open lumen.
Images courtesy of Prof. Andr. Jan Louis D’Hoore
Clinical Head of the Department of Abdominal Surgery,
University Clinics Gasthuisberg, Belgium

Discussion

The ColonRing™ with BioDynamix™ Anastomosis technology provides a durable, safe and effective anastomosis. The majority of post-surgical colonoscopies revealed a natural and seamless anastomosis with minimal or no visible scarring, and wide and open lumen. Positive results have been achieved throughout the colon, from less than 1 cm to more than 50 cm from the anal verge. Many successful cases have been performed in low chemo-radiated patients and those requiring pouch procedures. The ColonRing™ does not eliminate the complications associated with the surgery or the anastomosis, which may include leakage, stricture, bleeding, septic complications, extra-colonic complications and others, which are the same as those reported with other methods (e.g. staplers). The company continues to invest in research, utilizing industry-leading technology for capturing, managing and reporting clinical research data.

(1) Data as of March 31st, 2011
(2) Maximum pain recorded during hospitalization

Further information

If you are interested in learning more about the ColonRing™, please contact us.

ColonRing™  (CAR™)