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FDA clears Evolution duodenal stent for treatment of gastric outlet obstructions

The Food and Drug Administration has granted 510(k) clearance to Cook Medical for
its Evolution Duodenal Controlled-Release stent. This new stent expands palliative
care options for patients experiencing issues associated with malignant gastric outlet
obstruction, a late stage complication of a variety of gastrointestinal related cancers with
pancreatic cancer being the most common cause.


Studies indicate that as many as 50% of the malignancies involving the small intestine,
including pancreatic, gastric, duodenal and cholangiocarcinoma, occur in the duodenum. The
stent offers these patients a minimally invasive alternative to relieve the symptoms and
potentially life-threatening complications resulting from duodenal obstruction, such as
abdominal pain, vomiting, malnutrition and aspiration. The Evolution Duodenal Controlled-
Release stent, the only duodenal stent delivery system that allows for controlled release and
recapturability, is designed to provide physicians with precise control and maneuverability to
ensure proper placement and potentially reduce complications such as migration and
perforation. This stent is uniquely designed with 18 crowns at both the distal and proximal
ends, which allow the stent to adapt to the natural curvature of the anatomy. The proximal and
distal flanges are designed to reduce the risk of stent migration, while the patented Flexor

catheter with kink-resistant technology provides trackability and maneuverability for
deployment in the difficult anatomy of the duodenum. “The Evolution duodenal stent
includes several product features that are designed to make stent placement easier and more
precise for the physician,” said John G Lee, professor of clinical medicine at the HH Chao
Comprehensive Digestive Disease Center at University of California Irvine Medical
Center. “These features of the stent allow for better wall apposition and potentially reduce the
risk of migration, both of which are essential when treating patients with gastric outlet
obstructions.”
In a prospective multicentre European study of 23 patients, 21 had significant improvement
of symptoms. No early or late complications were recorded after a median follow-up of 8.8
weeks. Twenty-one patients (91.3%) were able to tolerate oral intake with a significant
improvement of GOOSS (gastric outlet obstruction scoring system) score. Preliminary
conclusions from researchers stated that the Evolution duodenal stent provided effective
palliation for malignant gastric outlet obstruction. Additionally, physicians have now
completed enrolment of 110 patients in a separate ongoing prospective multicentre study and
final analysis of data is presently underway. “The design of the stent and delivery system with
recapturability make it easier to deploy in hard-to-reach areas such as the distal duodenum,”
said Willis Parsons, medical director of the Northwest Community Hospital Gastroenterology
Center. “The stent platform is designed for optimal trackability and maneuverability in
difficult angulations, providing superior stability at crucial points during delivery.”