MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
NiTi introduces new closure
device for colorectal surgery
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By AMANDA PEDERSEN
Medical Device Daily Staff Writer
For about the last 30 years, anytime a patient has colorectal
surgery, either for cancer or for inflammatory diseases
like ulcerative colitis, they have to worry about certain
risks associated with the post-operative healing
process due to the use of surgical staples, which can crush
and puncture tissue. Leakage, inflammation, infection, and
bleeding are the primary concerns with this method of
bowel closure.
But a new staple-free closure device recently launched
in the U.S. for colorectal surgery could introduce colorectal
surgeons to a way of joining two segments of bowel that is
very different from what’s been done for the last three
decades. According to NiTi Surgical Solutions (Netanya,
Israel/Chesterfield, Missouri), the ColonRing is designed to
help the patient’s body heal naturally after this type of surgery.
NiTi says the FDA-cleared, CE-marked ColonRing represents
the first major advancement in this area in more than
30 years and could address the major drawbacks of staples.
NiTi CEO Itay Itzhaky told Medical Device Daily that for
the past three decades, two device companies have controlled
the colorectal closure space – US Surgical (now
Covidien; Mansfield, Massachusetts) and Ethicon Endo-
Surgery (Cincinnati), a business of Johnson & Johnson (New
Brunswick, New Jersey). In fact, he said more than 95% of
staplers used worldwide have been sold by one of those
two companies.
There are two types of staplers, Itzhaky noted, circular
staplers, which are commonly used for colon and
esophageal surgery, and linear staplers, which are more
commonly used in the small bowel and gastric applications.
The major problem with using staples for bowel operations
is leakage which Itzhaky said can be quite dangerous
– even life threatening – because spillover from the bowel
can lead to infection. He said the leakage rate can be up to
25% depending on what part of the bowel has been operated
on. Of course there is also the risk of bleeding, he said,
which occurs between 4% and 8% of the time, depending on
what part of the bowel it is – the bleeding rate is much
higher when staples are used in the small bowel, he noted.
“What we are trying to use in our product is actually
BioDynamix technology relying on compression,” Itzhaky
told MDD. Because NiTi’s colon ring is staple-free, there are
no bowel wall punctures, no risk of staple line bleeding,
and no permanent foreign bodies in the bowel as can happen
with surgical staples, Itzhaky said. 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 company
said. The nitinol leaf springs continuously apply force
range of pressure around the full circumference of the
anastomosis (the surgical connection of two parts of a hollow
organ). 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, according to NiTi. Itzhaky said the device is
expelled out of the body between seven and 14 days.
NiTi said the ColonRing is designed for anastomoses
throughout the alimentary tract for the creation of end-toend,
and end-to-side anastomoses in both open and laparoscopic
surgeries. The device is a sterile, single-patient, single-use
device, the company noted.
According to the company, more than 500,000 surgeries
involving GI tract resection are performed in the U.S.
each year. The ColonRing is comprised of nitinol, a metal
alloy that contains nickel and titanium. Nitinol exhibits
“shape memory” the company said. The ColonRing is
placed in cold water prior to surgery – and once implanted,
the patient’s body heat causes the Nitinol to return to its
original shape, which is what encourages the natural surgical
connection of the two parts of the bowel.
Itzhaky said NiTi is taking advantage of one special
quality of nitinol – its ability to force enhancement on tissue
and the ability to be able to control the exact force you
need to help the body to heal itself naturally. That makes
the healing process safer and reduces the leakage rates
and other risks that occur with the stapling method.
Itzhaky told MDD that since the ColonRing has been
available in the U.S., the vast majority of doctors who perform
colorectal surgeries have been willing to try the
device because the concept of compression of anastomosis
is something they were already familiar with; they just didn’t
have the tool to do it until now.
NiTi also has another product in its pipeline, the Hand
Compression Anastomosis Clip (CAC) 30 for side-to-side
and end-to-side anastomeoses. The Hand CAC 30, a palmsized
applier instrument, is designed for colorectal, gastric
and upper GI surgeries, NiTi said. The design and “excellent
maneuvering capability” advances open and hand-assisted
laparoscopic surgery (HALS) techniques, according to the
company. Like the ColonRing, the Hand CAC 30 is also a
sterile, single-patient, single-use device, and is also FDAcleared
and CE-marked.
(This story originally appeared in the July 14, 2009, edition
of Medical Device Daily).
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