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May 2nd, 2014

Cook Medical data presented at Digestive Disease Week®

Chicago, Ill. – This week is Digestive Disease Week (DDW), and at the world’s largest gathering of physicians and researchers in the gastroenterology field, nine abstracts and other clinical data will be presented on Cook Medical products. Cook’s line of EchoTip® ProCore™ High Definition Ultrasound Biopsy needles are featured in many of these presentations, including two randomized controlled trials by Drs. Masayuki Kitano and Srinadh Komanduri. There is also an economic analysis by Drs. Sachin Wani, Srinadh Komanduri and Ananya Das included in the presentations.

Dr. Kitano of Kinki University, Osaka-Sayama, Japan conducted a trial across nine Japanese centers and included 214 patients. The trial aimed to compare the availability of histological diagnosis between the EchoTip ProCore with a core trap and the standard 25 gauge EchoTip Ultra. “This prospective multicenter randomized controlled trial indicated that the 25G ProCore needle with a single pass offers significantly better sample quality for histological diagnosis of solid pancreatic tumors compared with the 25G standard needle,” said Dr. Kitano in the trial’s conclusion.

Drs. Wani of the University of Colorado, Komanduri of Northwestern University, and Das of the Arizona Center for Digestive Health, performed an economic analysis that compared two strategies in patients undergoing endoscopic ultrasound-guided tissue sampling. The two strategies compared included endoscopic ultrasound fine needle aspiration (EUS-FNA) with an on site cytopathologist, and endoscopic ultrasound fine needle biopsy (EUS-FNB) without an on site cytopathologist. This included two passes, and specimens were then submitted to pathology for histologic evaluation. Through this cohort, Drs. Wani, Komanduri and Das showed that EUS-FNB was more cost-effective than EUS-FNA for pancreatic and non-pancreatic masses. These results were confirmed in a sensitivity analysis (Monte Carlo analysis) that included a hypothetical cohort of 1000 patients undergoing EUS-guided tissue sampling comparing EUS-FNA with EUS-FNB. “This cost-analysis suggests that EUS-FNB of pancreatic and non-pancreatic masses may be a more cost-effective strategy than EUS-FNA,” said Wani in the analysis’ conclusion.

The primary aim of Dr. Komanduri’s study, which included 128 patients from six centers in the United States, was to compare the overall diagnostic yield of malignancy of EUS-FNA to EUS-FNB using a crossover design. “Results of this multicenter randomized controlled trial demonstrate superior diagnostic yield and specimen adequacy for non-pancreatic mass lesions sampled by EUS-FNB,” said Komanduri in the trial’s conclusion.

“These annual physician meetings are the best forum for sharing the latest discoveries in patient care,” said Barry Slowey, global leader of Cook Medical’s Endoscopy division. “We believe that the ProCore technology has huge implications for diagnosing patients, so it’s exciting to see our products featuring in many of these discussions.”

Saturday, May 3

•Prospective Multicenter Randomized Controlled Trial of Histological Diagnostic Yield Comparing 25G EUS-FNA Needles with and Without a Core Trap in Patients with Solid Pancreatic Masses

oPresented at S505 Topic Forum, 10:00 a.m. – 11:30 a.m.
•Biomarker Assessment From EUS Guided Biopsy Predicts Survival Outcomes and Surgical Treatment in Pancreatic Carcinoma

oPresented at South Hall Poster Session, 8:00 a.m. – 5:00 p.m.

Monday, May 5

•EUS-FNA of Solid Pancreatic Lesions: a Prospective, Randomized, Single Blinded, Comparative Study Using the 22-Gauge EchoTip® ProCore™ HD and the 22-Gauge EchoTip® Ultra HD Endoscopic Ultrasound Needles
oPresented at ASGE Poster Sessions, 8:00 a.m. – 5:00 p.m.
•EUS-Guided Fine Needle Biopsy for Histopathologic Evaluation of Solid Liver Masses
oPresented at ASGE South Hall Poster Sessions, 8:00 a.m. – 5:00 p.m.
•Comparison of Capillary vs Aspiration Technique in Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA): a Preliminary Report
oPresented at ASGE Poster Session, 8:00 a.m. – 5:00 p.m.

Tuesday, May 6

•Fine Needle Biopsy (FNB) is More Cost-Effective Than Fine Needle Aspiration (FNA) for Endoscopic Ultrasound Guided Tissue Sampling: an Economic Analysis
oPresented at S505 Topic Forum, 2:00 p.m. – 3:30 p.m.
•A Multicenter Prospective Randomized Controlled Cross-Over Trial Comparing Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) for Pancreatic and Non-Pancreatic Masses
oPresented at S505 Topic Forum, 2:00 p.m. – 3:30 p.m.

Cook Medical will be showing the EchoTip ProCore at their booth, #2538, along with products in hemostasis, stenting and biliary. Cook is also offering hands-on training in the booth.

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family-owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at, and for the latest news, follow us on TwitterFacebook and LinkedIn.

Dr. Komanduri is a paid consultant for Cook Medical.