Product Information - AFS Medical
Product Information - AFS Medical
Product Information - AFS Medical
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Compression Anastomosis for Low Anterior Resection (LAR)<br />
Recent Data<br />
The Study LAR Patients Leak Rate n (%)<br />
Buchberg et al. 2011 23 1 (4.3%)<br />
Dauser et al. 2011 29 1* (3.4%)<br />
Lee et al. 2011 65 1 (1.5%)<br />
Avgoustou et al. 2012 31 1 (3.2%)<br />
Masoomi et al. 2012 362 7 (1.9%)<br />
D’hoore et al. 2012 98 1* (1.0%)<br />
For Compression Anastomosis<br />
in Colorectal Surgery<br />
*LAR defined as 10 cm from anal verge.<br />
ColonRing - natural healing and excretion<br />
of the Compression Ring<br />
novoGI is committed<br />
to advancing patient care<br />
by providing an expanding range<br />
of device driven solutions<br />
for GI disease management<br />
Clinically proven core technology<br />
• Over 10,000 procedures worldwide<br />
• Over 40 peer-review publications<br />
Patented nitinol-based compression ring<br />
Especially effective in low anterior<br />
resection (LAR) procedures<br />
There are over 40 peer-reviewed publications on novoGI’s<br />
clinically proven compression anastomosis technology.<br />
See Peer-review Library at novoGI.com and learn more.<br />
www.novoGI.com<br />
Catalog No. M025<br />
© 2012 novoGI Inc. All rights reserved.
for Compression Anastamosis in Colorectal Surgery<br />
Deployment<br />
After resection, the Compression Ring<br />
with patented Nitinol Leaf Springs<br />
is deployed to reconnect the colon<br />
after resection.<br />
Withdrawal of Applicator<br />
The Applicator is withdrawn distal<br />
to the anastomosis site, which<br />
helps preserve the integrity<br />
of the anastomosis.<br />
Nitinol at work<br />
During compression anastomosis, the<br />
Compression Ring’s Nitinol Leaf Springs<br />
compress the tissue dynamically<br />
according to tissue thickness, while<br />
exerting a controlled, constant force<br />
along the anastomotic line.<br />
Biological forces at work<br />
Anastomotic tissue compressed<br />
within the Compression Ring sloughs<br />
while new tissue is peripherally<br />
formed.<br />
Natural healing<br />
Healing of the anastomotic tissue<br />
is facilitated by a less prolonged and<br />
intense inflammatory response.<br />
Excretion<br />
Following natural healing,<br />
the Compression Ring is excreted<br />
naturally.<br />
1,180 patients,<br />
362/1180 LAR procedures in<br />
16 countries (167 medical centers)<br />
• Low leakage rate of 3.2 %; 3.2% open<br />
(17/535) and 3.2% laparoscopic procedures<br />
(21/645)<br />
• Very low leakage rate for LAR 1.9% (7/362)<br />
• Compression anastomosis for LAR cases may<br />
lead to decreased anastomotic complications<br />
Masoomi H, Mills S, Carmichael JC, Senagore AJ, Stamos MJ.<br />
Compression anastomosis ring device in colorectal anastomosis:<br />
a review of 1,180 patients. Am J Surg. 2012. In press.<br />
*LAR defined as 10 cm from anal verge. According to the<br />
literature, leakage rates for low anterior resection (LAR)<br />
can range from 8% to approximately 30%. Schmidt O, Merkel<br />
S, Hohenberger W. Eur J Surg Oncol 2003, Taflampas P,<br />
Christodoulakis M, Tsiftsis DD. Surg Today 2009, Lim M, Akhtar<br />
S, Sasapu K, et al. Dis Colon Rectum 2006, 49(10):1611-9, Akyol<br />
AM, McGregor JR, Galloway DJ, et al. Int J Colorectal Dis 1991,<br />
JT, Lai HS, Lee PH. Ann Surg Oncol 2007, Brisinda G, Vanella S,<br />
Cadeddu F, et al. J Surg Onc<br />
266 patients,<br />
98/266 LAR procedures in<br />
13 medical centers<br />
• Low leakage rate for LAR - 4%<br />
(95% C.I. 0.0% - 8.0%) overall including leaks,<br />
abscess, fistula<br />
• 97.4% rated the device very easy to use<br />
• No device-related mortality<br />
• Majority of patients did not notice excretion<br />
D'hoore A, Cohen S, Albert M, Herbst F, Senagore A, Stamos<br />
MJ, Pahlman L, Wexner SD. COMPRES final results: nitinol<br />
compression anastomosis results in a much lower than expected<br />
rate of anastomotic leak in low anterior resection (LAR). Poster<br />
presented at: Annual Scientific Meeting of the American Society<br />
of Colorectal Surgeons (ASCRS); June 2-6, 2012; San Antonio, TX.<br />
“Compression anastomotic<br />
healing was associated with<br />
less inflammation, scarring,<br />
and foreign body reactions<br />
as compared to stapled<br />
anastomoses.”<br />
Berho M, Fleshman JW, Wexner SD, Anug<br />
AM, Pelled D. Histopathological advantages<br />
of compression ring anastomosis healing as<br />
compared to stapled anastomosis in a porcine<br />
model: a blinded comparative study. Poster<br />
presented at: Annual Scientific Meeting of<br />
the American Society of Colorectal Surgeons<br />
(ASCRS); June 2-6, 2012; San Antonio, TX.<br />
Thin Tissue<br />
ColonRing is a surgical device intended for colorectal anastomotic procedures and may be associated with complications such as leakage, stricture, bleeding, sepsis and other extra-colonic complications as occasionally seen with any anastomotic technique.<br />
Thick Tissue<br />
How It Works<br />
novoGI harnesses the unique properties of<br />
nitinol – super elasticity, shape memory, and<br />
constancy of stresses - to deliver true, dynamic<br />
control of the tissue compression process for<br />
compression anastomosis.<br />
novoGI<br />
Compression Anastomosis<br />
• Viable bowel wall layers are<br />
preserved (not punctured)<br />
• Compression Ring is a<br />
temporary implant<br />
• Reduced foreign body reaction<br />
• Preservation of continuity of<br />
bowel wall layers<br />
• Recovery of lumen size