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May 21st, 2012

Cook Expands Line of Endoscopic Ultrasound Needles with Addition of Smallest Gage on the Market Designed for Histological and Cytological Samples

Bloomington, Ind. — Cook Medical has added a 25 gage needle to its EchoTip® ProCore™ line of fine needle biopsy (FNB) histology needles, which are designed for use in a procedure known as endoscopic ultrasound, or EUS. The EchoTip ProCore is a single-use, disposable needle for FNB intended for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses.

The new 25 gage biopsy needle enabled a single-pass diagnosis of 88 percent (91 percent when including subsequent passes) in suspected tumors of the pancreas when pathologists examined both the histological and cytological yields obtained.1 No complications were seen in any of the patients.

The American Cancer Society estimates that 43,920 people in the United States will be diagnosed with pancreatic cancer in 2012.2 Because of its location deep inside the body and lack of symptoms, pancreatic cancer can be difficult to detect and diagnose in the early stages.Endoscopic ultrasound is an established procedure for diagnosing GI cancers and determining the stage of their development.

Most often, a very fine needle is used to gain samples from hard-to-reach areas such as the pancreas, but fine-needle aspiration (FNA) can have limited yield and sensitivity for certain kinds of tumors or in some anatomical locations. Using the 25 gage EchoTip ProCore needle may lead to an increase in diagnosis for pancreatic malignancies on the first pass because of its small size and a modified slow-pull technique for tissue acquisition.

The ProCore line of needles is uniquely designed to obtain both cytological and histological samples from lesions in the gastrointestinal tract and has been used in the treatment of tens of thousands of patients. It builds on the advantages of the EchoTip Ultra line, and its use and functionality are almost identical to the EchoTip Ultra ultrasound needle. The core trap at the tip of the needle receives the tissue sample while the reverse bevel promotes the collection of core sample by shearing material from the target lesion during retrograde movement of the needle.

“The 25 gage EchoTip ProCore has a unique advantage because physicians are able to obtain histological and cytological samples on a single-pass or limited-pass basis,” said Dr. Kenneth Chang, executive director, H.H. Chao Comprehensive Digestive Disease Center at the University of California-Irvine. “Since the single-pass yield is so high with the 25 gage ProCore, the needle streamlines the EUS procedure for physicians and may require fewer patients to return to their doctors for further sampling.”

“A full-line supplier of endoscopic devices, Cook has led the way in ultrasound technologies for more than 14 years,” said Barry Slowey, global business unit leader for Cook Medical’s Endoscopy division. “The 25 gage EchoTip ProCore and our entire fine-needle-biopsy line have changed the landscape of EUS globally, providing clinicians with the latest innovations to improve patient care.”

The 25 gage EchoTip ProCore needle is now available to physicians in most major markets globally.

About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving more than 40 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit Follow Cook Medical on Twitter and LinkedIn.
Dr. Chang is a paid consultant for Cook Medical.

1 Iwashita T, Nakai Y, Samarasena JB, et al. High single-pass diagnostic yield (cytology and histology) of a novel 25-gauge core biopsy needle for endoscopic ultrasound-guided fine needle aspiration and biopsy (EUS-FNAB) in pancreatic solid lesions. Poster presented at: Digestive Disease Week 2012; May 19-22, 2012; San Diego, CA. Poster Sa1530.
2 What are the key statistics about pancreatic cancer? American Cancer Society Web site. Updated January 13, 2012. Accessed April 19, 2012.
3 Can pancreatic cancer be found early? American Cancer Society Web site. Updated January 13, 2012. Accessed April 19, 2012.