Product Information - AFS Medical

Compression Anastomosis for Low Anterior Resection (LAR)
Recent Data
The Study LAR Patients Leak Rate n (%)
Buchberg et al. 2011 23 1 (4.3%)
Dauser et al. 2011 29 1* (3.4%)
Lee et al. 2011 65 1 (1.5%)
Avgoustou et al. 2012 31 1 (3.2%)
Masoomi et al. 2012 362 7 (1.9%)
D’hoore et al. 2012 98 1* (1.0%)
For Compression Anastomosis
in Colorectal Surgery
*LAR defined as 10 cm from anal verge.
ColonRing - natural healing and excretion
of the Compression Ring
novoGI is committed
to advancing patient care
by providing an expanding range
of device driven solutions
for GI disease management
Clinically proven core technology
• Over 10,000 procedures worldwide
• Over 40 peer-review publications
Patented nitinol-based compression ring
Especially effective in low anterior
resection (LAR) procedures
There are over 40 peer-reviewed publications on novoGI’s
clinically proven compression anastomosis technology.
See Peer-review Library at novoGI.com and learn more.
www.novoGI.com
Catalog No. M025
© 2012 novoGI Inc. All rights reserved.

for Compression Anastamosis in Colorectal Surgery
Deployment
After resection, the Compression Ring
with patented Nitinol Leaf Springs
is deployed to reconnect the colon
after resection.
Withdrawal of Applicator
The Applicator is withdrawn distal
to the anastomosis site, which
helps preserve the integrity
of the anastomosis.
Nitinol at work
During compression anastomosis, the
Compression Ring’s Nitinol Leaf Springs
compress the tissue dynamically
according to tissue thickness, while
exerting a controlled, constant force
along the anastomotic line.
Biological forces at work
Anastomotic tissue compressed
within the Compression Ring sloughs
while new tissue is peripherally
formed.
Natural healing
Healing of the anastomotic tissue
is facilitated by a less prolonged and
intense inflammatory response.
Excretion
Following natural healing,
the Compression Ring is excreted
naturally.
1,180 patients,
362/1180 LAR procedures in
16 countries (167 medical centers)
• Low leakage rate of 3.2 %; 3.2% open
(17/535) and 3.2% laparoscopic procedures
(21/645)
• Very low leakage rate for LAR 1.9% (7/362)
• Compression anastomosis for LAR cases may
lead to decreased anastomotic complications
Masoomi H, Mills S, Carmichael JC, Senagore AJ, Stamos MJ.
Compression anastomosis ring device in colorectal anastomosis:
a review of 1,180 patients. Am J Surg. 2012. In press.
*LAR defined as 10 cm from anal verge. According to the
literature, leakage rates for low anterior resection (LAR)
can range from 8% to approximately 30%. Schmidt O, Merkel
S, Hohenberger W. Eur J Surg Oncol 2003, Taflampas P,
Christodoulakis M, Tsiftsis DD. Surg Today 2009, Lim M, Akhtar
S, Sasapu K, et al. Dis Colon Rectum 2006, 49(10):1611-9, Akyol
AM, McGregor JR, Galloway DJ, et al. Int J Colorectal Dis 1991,
JT, Lai HS, Lee PH. Ann Surg Oncol 2007, Brisinda G, Vanella S,
Cadeddu F, et al. J Surg Onc
266 patients,
98/266 LAR procedures in
13 medical centers
• Low leakage rate for LAR - 4%
(95% C.I. 0.0% - 8.0%) overall including leaks,
abscess, fistula
• 97.4% rated the device very easy to use
• No device-related mortality
• Majority of patients did not notice excretion
D'hoore A, Cohen S, Albert M, Herbst F, Senagore A, Stamos
MJ, Pahlman L, Wexner SD. COMPRES final results: nitinol
compression anastomosis results in a much lower than expected
rate of anastomotic leak in low anterior resection (LAR). Poster
presented at: Annual Scientific Meeting of the American Society
of Colorectal Surgeons (ASCRS); June 2-6, 2012; San Antonio, TX.
“Compression anastomotic
healing was associated with
less inflammation, scarring,
and foreign body reactions
as compared to stapled
anastomoses.”
Berho M, Fleshman JW, Wexner SD, Anug
AM, Pelled D. Histopathological advantages
of compression ring anastomosis healing as
compared to stapled anastomosis in a porcine
model: a blinded comparative study. Poster
presented at: Annual Scientific Meeting of
the American Society of Colorectal Surgeons
(ASCRS); June 2-6, 2012; San Antonio, TX.
Thin Tissue
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.
Thick Tissue
How It Works
novoGI harnesses the unique properties of
nitinol – super elasticity, shape memory, and
constancy of stresses - to deliver true, dynamic
control of the tissue compression process for
compression anastomosis.
novoGI
Compression Anastomosis
• Viable bowel wall layers are
preserved (not punctured)
• Compression Ring is a
temporary implant
• Reduced foreign body reaction
• Preservation of continuity of
bowel wall layers
• Recovery of lumen size