Healthcare Industry News: NiTi Surgical Solutions
News Release - May 4, 2009
NiTi Surgical Solutions Announces U.S. Launch of Revolutionary ColonRing Surgical Device at ASCRS Annual MeetingFirst Major Advance in Closure Technology for Colon Surgery Patients in More Than 30 Years
HOLLYWOOD, Fla. & CHESTERFIELD, Mo.--(HSMN NewsFeed)--NiTi Surgical Solutions, an innovative surgical device company, today announced the U.S. commercial launch of ColonRing(TM) - its revolutionary closure technology for colorectal surgery - at the Annual Scientific Meeting of the American Society of Colorectal Surgeons (ASCRS) this week in Hollywood, Florida. 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 leakage, inflammation, infection, and 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(TM) 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(TM) 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.
“The launch of ColonRing in the United States is an exciting and important milestone for NiTi,” said Itay Itzhaky, chief executive officer of NiTi Surgical Solutions. “With our global reach, fully-integrated operations, and commitment to innovation, we have a unique opportunity to be the technology leader in bowel anastomosis as we continue to develop a broad portfolio of CE-marked and FDA-cleared surgical devices for tissue reconnection. We are committed to advancing BioDynamix Anastomosis to provide surgeons with a safer, more effective, and easier method of addressing the challenges of gastrointestinal surgery.”
About ColonRing(TM) with BioDynamix(TM) Anastomosis Technology
NiTi Surgical Solutions has leveraged the features of Nitinol in the ColonRing technology. 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.
In human trials and clinical practice, BioDynamix Anastomosis technology has shown the potential to provide durable anastomosis with encouraging results in the rate of complications, particularly in low cases. Colonoscopic examination at six months demonstrated a satisfactory and seamless anastomosis. In animal 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.
About NiTi(TM) Surgical Solutions
NiTi Surgical Solutions is focused on the BioDynamix(TM) of natural healing, offering state-of-the-art medical devices to optimize surgical outcomes for patients and physicians. NiTi Surgical Solutions currently markets its novel ColonRing(TM) device - the next generation of closure technology for colorectal resection - providing surgeons with a potentially safer and more effective alternative to standard staple-dependent closure techniques. NiTi continues to expand its core competencies and innovative technology to a variety of advanced surgical products, techniques, and procedures. NiTi Surgical Solutions is a privately held, venture backed company with headquarters in Israel and the U.S. The company’s investors include Alice Ventures, Evergreen Venture Partners, Israel Healthcare Ventures, MMT Funds and SCP Vitalife. For more information, please visit www.nitisurgical.com.
Source: NiTi Surgical Solutions
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