NiTi Surgical Solutions Introduces Investigational Bowel Anastomosis Device At American College Of Surgeons Annual Meeting

Main Category: Medical Devices / Diagnostics
Also Included In: Colorectal Cancer;  GastroIntestinal / Gastroenterology
Article Date: 14 Oct 2009 - 0:00 PDT

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NiTi™ Surgical Solutions, an innovative surgical device company, announced that it will showcase its new, investigational bowel anastomosis device this week at the American College of Surgeons (ACS) 95th Annual Clinical Congress in Chicago, Illinois. The device, which will be marketed as BowelRing™, represents the company's next advancement in its innovative BioDynamix™ Anastomosis Technology platform.

NiTi's unique line of products utilizes Nitinol-based elements to press together the ends of resected tissue, enabling natural reconnection and healing after removing a section as part of a surgery. The company's first marketed product launched earlier this year, ColonRing™, provides physicians with a revolutionary reconnection technology for surgeries such as colon cancer surgery, and represents the first of several Nitinol devices NiTi expects to bring to market as part of its innovative platform. The BowelRing with BioDynamix Anastomosis Technology is currently being evaluated for side-to-side anastomosis, most often utilized in small bowel and right colon procedures.

"NiTi's innovative BioDynamix Anastomosis Technology offers surgeons a revolutionary approach to anastomosis that may improve the surgical experience for surgeons and physicians, and most importantly, the healing process for patients," said Itay Itzhaky, chief executive officer of NiTi Surgical Solutions. "Following the successful launch of our first marketed product, the ColonRing, we look forward to further expanding our commercial presence in the U.S. and globally in the coming months as we broaden our portfolio of innovative surgical devices."

NiTi Surgical Solutions' shape memory surgical rings, clips, and appliers represent the next generation in internal tissue anastomosis devices. These advanced devices are designed for treatment of colorectal, small bowel, gastric and upper gastrointestinal disease requiring surgical anastomosis. Based on the unique properties of BioDynamix Anastomosis, BowelRing may provide physicians with a staple-free anastomosis technology for bowel and certain colon surgeries, potentially eliminating bleeding at the anastomosis site and minimizing complications following surgery.

NiTi plans initiation of clinical trials of the new device and submission to the U.S. FDA during 2010.

About ColonRing™ with BioDynamix™ Anastomosis Technology

NiTi Surgical Solutions has leveraged the features of Nitinol in the ColonRing, NiTi's Compression Anastomosis Ring device recently launched in the United States. ColonRing represents a revolutionary anastomosis technology for surgeries such as colon cancer surgery and has been successfully applied in thousands of patients. In the ColonRing, the Nitinol leaf springs stretch to open the ring for placement in the bowel, and then gradually return to their original closed position, adapting to variations in tissue thickness and accommodating compressed tissue. The Nitinol leaf springs continuously apply constant force range of pressure around the full circumference of the anastomosis. As the compression progresses over several days, the tissue trapped within the ring becomes necrotic, while healthy tissue is generated along the ring's outer perimeter.

ColonRing represents the first major advancement in colorectal surgery in more than 30 years and addresses the significant drawbacks of traditional staples. Colonoscopic examination at six months demonstrated an effective, seamless anastomosis with excellent wound healing. In animal pre-clinical trials, ColonRing resulted in a time zero anastomotic burst strength up to three times stronger than circular staplers. In addition, histologic examination of resected anastomoses showed complete reepithelialization of the mucosa and a uniform anastomosis showing full recovery to the natural multi-layer tissue structure.

Source
NiTi™ Surgical Solutions