Clinical studies show Boston Scientific WallFlex enteral stents safe
29 February 2012
Boston Scientific Corporation (NYSE: BSX) has announced that
it welcomes positive results from three studies of its WallFlex enteral
stent systems, a family of self-expanding metal stents (SEMS) used to
alleviate obstructive symptoms caused by cancers of the gastrointestinal
The studies, published in peer-reviewed medical journals, determined
the WallFlex Stents to be safe and effective for the treatment of
malignant colorectal and gastroduodenal obstruction.
The first publication appeared in the October 2011 issue of
Gastrointestinal Endoscopy, and reported the short-term safety
and effectiveness of the Boston Scientific WallFlex Enteral Colonic
Stent for relieving malignant colorectal obstruction. This
447-patient study represents the largest prospective, multi-center
series to date of colonic SEMS placement in both palliative and
The WallFlex Enteral Colonic Stent was determined to be safe and
effective for treatment of malignant colorectal obstruction with a
clinical success rate of 90.5 percent. The authors determined that
SEMS allowed most bridge-to-surgery patients to have an elective
surgical procedure without a colostomy and most incurable patients
to receive minimally invasive palliation instead of surgery.
"Based on results from this study, physicians should consider
SEMS as a first-line treatment option for patients with malignant
colorectal obstruction," said Soren Meisner, M.D., Bispebjerg
Hospital, Copenhagen, Denmark and principal author of the study.
"SEMS provide patients with a less-invasive alternative to surgery
and may also improve quality of life."
The second publication, appearing in the December 2011 issue of
The American Journal of Gastroenterology, reports on 182
patients from the WallFlex Colonic Stent registries who received a
WallFlex Colonic Stent as a bridge to surgery. Findings show rates
of 97.8 percent procedural success and 94 percent clinical success,
prompting the authors to conclude that the WallFlex Colonic Stent is
both safe and effective as a bridge-to-surgery treatment in patients
with acute malignant obstruction.
Third, results from the international, multi-center WallFlex
Duodenal Stent registry were published in the January 2012 issue of
Digestive and Liver Disease. The largest prospective study
of its kind assessed the treatment of malignant gastroduodenal
obstruction in 202 patients. Results confirmed the safety and
effectiveness of the WallFlex Enteral Duodenal Stent, which
demonstrated procedural and clinical success rates of 98 and 91
The authors concluded that adoption of duodenal stenting could
result in this minimally invasive procedure becoming standard of
care when managing inoperable patients with advanced cancer
experiencing gastric outlet obstruction.
"Boston Scientific is focused on conducting research that has the
potential to expand treatment options and improve patient care. Our
Endoscopy group has invested millions of dollars over the past five
years to conduct clinical trials involving nearly 1,400 patients at
more than 110 medical centers in 21 countries," said David Pierce,
President of the Endoscopy Division at Boston Scientific. "We are
honored to partner with worldwide experts in gastrointestinal
endoscopy to design and conduct trials with high standards of
quality and scientific rigor."
Source: Boston Scientific