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Completion of 500 Procedures With NiTi Surgical Solutions' Compression Anastomosis Ring Positions Device as Viable Alternative to Surgical Stapling
SAN FRANCISCO, Oct. 10, 2008 (GLOBE NEWSWIRE) -- NiTi(tm) Surgical Solutions, a privately-held company focused on advancing medical technologies for gastrointestinal (GI) surgery, today announced that the NiTi Compression Anastomosis Ring, a new device that reconnects tissues naturally after colorectal surgery, has been used in 500 colorectal surgical procedures. The device, which represents a revolutionary advancement in tissue reconnection, a process known as anastomosis, has shown promising results in accelerating recovery time, in promoting faster, natural healing and in reducing post-surgical complications over mechanical stapling, the surgical standard for more than 30 years.
NiTi Surgical Solutions will display its revolutionary technology and discuss preliminary outcomes of its use at the American College of Surgeons (ACS) 94th Clinical Congress, taking place October 12th-16th in San Francisco.
Each year, more than 500,000 surgeries involving GI tract resection are performed in the United States after removing sections of the colon damaged by colon cancer, inflammatory bowel disease, diverticulitis and other GI conditions. Some of these patients have suffered from post-surgical complications including leakage, inflammation, infection and bleeding around the punctured connection site when tissues are reconnected by mechanical stapling or hand sewing. Related scar tissue from circular staples, which are left permanently in the body, may further hinder the healing process and cause obstruction that can reduce the intestinal passages.
The new alternative is the NiTi Compression Anastomosis Ring, also known as CAR(tm) 27, which has been cleared by the U.S. Food and Drug Administration for colorectal and gastrointestinal surgeries and is also CE marked for marketing in Europe. The completion of 500 procedures using the NiTi ring brings surgeons around the world a safe, viable way to reconnect tissue after surgeries and new hope to their patients.
The Compression Anastomosis Ring reconnects tissue using a sophisticated ring with parts made of advanced Nitinol, a strong but pliable nickel titanium that has "shape memory." During placement, elasticity of the Nitinol leaf springs enables the ring to adapt to differences in tissue thickness, uniformly bringing together tissues while applying consistent, controlled pressure for natural healing to occur. When the tissue connection is healed, within weeks, the ring passes out of the body, leaving behind healthy tissue that shows minimal signs of the surgery performance and leaving no foreign material in the body unlike staples which are left permanently behind.
The ring is placed using an applicator similar to that used with standard circular staples. Unlike stapling devices, due to its unique design, the CAR(tm) 27 applier is not withdrawn through the newly created reconnected tissue, eliminating the potential for trauma.
NiTi Surgical Solutions to Discuss Preliminary Outcomes at ACS Clinical Congress
To date, 83 surgeons at 60 sites, including major academic medical centers and community-based hospitals throughout North America, Europe, and Israel, have used the device in 500 procedures involving men and women ranging in age from 25 to 90. Patients were approximately 62 percent female and 38 percent male, and their average age was 62 years.
In the cases in which results were given, surgeons generally reported a natural and seamless anastomosis with minimal or no visible scarring, and wide and patent lumen, which is the space within the intestines. The average time taken to reconnect tissue was eight minutes and the average incidence of leaks reduced considerably as the number of procedures increased.
According to the surgeons employing the device, the patients' recovery time and length of stay in a hospital seemed to be reduced, and in the vast majority of the cases the device was expelled unnoticeably from the body within weeks after surgery, as intended. In general, the surgeons found the NiTi Compression Anastomosis Ring to be safe, effective, and easy to use, mainly because the device applicator operation is nearly identical to that of current devices. Not a single surgeon using the device reported that it was difficult to operate.
"Our initial procedures prove that NiTi's reconnection device has the potential to replace the current standard of surgical stapling for closure following colorectal surgery," said Dr. Stephen M. Cohen, a colorectal surgeon at Southern Regional Medical Center in Atlanta who has used the compression ring in more than 40 procedures. "Our patients benefited immensely from this new technique, experienced minimal complications associated with traditional stapling methods, and recovered faster than patients with surgical staples. The NiTi compression ring is a true medical breakthrough that will allow surgeons to minimize discomfort for patients for many years to come."
Further information is available at http://www.nitisurgical.com/
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