E-Z-EM introduces PROTOCO2L colon insufflation system and InnerviewGI workstation for virtual colonoscopy

Westbury 11 March 2002E-Z-EM Inc. has begun marketing its InnerviewGI workstation for virtual colonoscopy procedures. The product is able to render 3D images in just seconds, and provides imaging professionals with multiple 3D view options as well as synchronised 2D and 3D views of the colon. The company has also received 510(k) FDA-clearance to market its new colon insufflation system, consisting of an automated insufflation device and disposable administration sets, for virtual colonoscopy procedures.

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The colon insufflation system, trade-named PROTOCO2L, uses carbon dioxide to distend the colon for accurate imaging diagnosis and patient comfort. Virtual colonoscopy, also referred to as CT colonography, or CTC, is an innovative technology which visualises the gastro-intestinal tract using advanced CT imaging and 3D computer reconstruction of that image data.

InnerviewGI features cutting-edge medical technology to help practitioners quickly and effectively screen patients for polyps and other signs of colorectal disease. Designed with today's radiology suite in mind, InnerviewGI facilitates fast, accurate diagnosis by providing:

  • Dedicated software appliance in a proven user interface for virtual colonoscopy, compatible with all CT and MR scanners utilising DICOM 3 protocols.
  • Multiple 3D view options rendered with industry-leading speed that include Endoscopic View, for intra-luminal "fly-through" of the colon, and Point of Interest View, for easy identification, analysis, and dissection of suspected pathology.
  • Versatile user interface to allow synchronised 2D and 3D views of the colon, as well as side-by-side comparison of prone and supine images, or pre- and post-surgical images.
  • Easy-to-use measurement tools to provide accurate measurement of anatomical structure/suspect pathology.
  • Volume rendering techniques to ensure accurate reconstruction of the bowel mucosa and internal structure.

InnerviewGI is powered by Vital Images' Vitrea 2 software and features real time navigation of 3D volume data. This permits the user to better visualise and understand internal structures and disease conditions by creating two- and three-dimensional views of the colon and interactively navigating within these images. Vital Images is a provider of 3D imaging workstations for use in disease screening applications, clinical diagnosis, and therapy planning.

Anthony A. Lombardo, President and CEO of E-Z-EM, stated: "We believe that virtual colonoscopy will become a significant part of the future of gastro-intestinal imaging. This procedure should play an important role in the fight against colon cancer by making screening more accessible to the general population, and E-Z-EM is positioning itself to be a key player in this market."

Medical imaging literature has reported that the use of carbon dioxide instead of room air can reduce patient pain and discomfort from traditional colonography procedures. PROTOCO2L now brings the advantages of carbon dioxide to virtual colonoscopy, where insufflation of the colon is essential to a clinically sound examination. The PROTOCO2L colon insufflation system makes carbon dioxide insufflation a practical and simple procedure for the practitioner.

"In order to continue to build upon our 40-year franchise in the GI marketplace, E-Z-EM has become the complete source for virtual colonoscopy products. InnerviewGI and PROTOCO2L are examples of our commitment to produce the broadest tool kit available for virtual colonoscopy practitioners, including 3D computer software, hardware and consumables, everything that is needed before, during, and after the CT procedure", continued Mr. Lombardo.

The National Cancer Institute estimates that there were over 100.000 new cases of colon cancer diagnosed in the United States in 2001. Research indicates that early detection and intervention can reduce mortality from the disease by up to 90 percent while also reducing the incidence of non-colon cancers. Furthermore, the American Cancer Society recommends screening for the 74 million people over the age of 50. However, it is estimated that only 10 to 12 million individuals are screened every year, and many of these patients are screened with fecal occult blood tests that can yield less-than-optimal results. It is believed that virtual colonoscopy could lead to a substantial increase in the number of patients being screened for colorectal cancer.

According to Dr. Judy Yee, Associate Professor of Radiology, UCSF, and Chief of CT and GI Radiology at the San Francisco VA Medical Center, "The most common post-procedure complaint voiced by patients is the discomfort and cramping that can result from air remaining in the bowel after an examination. Using carbon dioxide, which is absorbed into the body through the intestinal wall, I have found that many patients are more comfortable after the procedure and have virtually no discomfort. PROTOCO2L has made colon distention easy for our practitioners and our patients."

Beyond the comfort of carbon dioxide, insufflation with the PROTOCO2L system offers many advantages over traditional hand insufflation. Gas pressure is regulated and constant, minimising the pressure spikes that can occur during manual insufflation. Safety controls are designed to protect the patient from overpressure conditions. And since the process is entirely automated it can help improve staff productivity.

The latex-free PROTOCO2L administration set is simple to install and remove. An in-line fluid collection trap captures patient effluent, removing it from the path of the carbon dioxide. And a hydrophobic filter helps reduce the opportunity for patient cross-contamination. PROTOCO2L displays instantaneous gas pressure, records the total volume insufflated during the procedure, and even alerts the operator when the carbon dioxide cylinder is low. And it operates on standard utilities, so it is easy to transport and use in any environment.

In addition to InnerviewGI and PROTOCO2L, E-Z-EM's virtual colonoscopy tool kit includes LoSo Prep and NutraPrep patient-friendly colon preparation products and nutritional meal kits, and a tagging agent trade-named Tagitol which helps practitioners distinguish pathology from colonic residue. Offering complete pre- to post-procedure capabilities for the virtual colonoscopy practitioner, E-Z-EM's tool kit should help position the company as an expert in this new health care marketplace.

E-Z-EM, a manufacturer of contrast agents for gastro-intestinal radiology, has developed the only CT injector on the market which can help detect contrast extravasation, the new EmpowerCT with patented EDA technology. The company's wholly-owned subsidiary, AngioDynamics, manufactures a wide range of products, including angiographic, vascular access, thrombolytic, angioplasty, stents, as well as abdominal infection drainage products. AngioDynamics' focus is on diagnostic and therapeutic products for interventional radiology and other areas of minimally invasive surgery. Enteric Products Inc., another subsidiary, develops, manufactures, and markets tests for detection of the ulcer- and cancer-causing bacterium Helicobacter pylori.


Leslie Versweyveld

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