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FDA, CDC and ASM Release New Duodenoscope Surveillance and Culturing Protocols

February 26, 2018 — The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with other endoscope culturing experts, announced the availability of voluntary, standardized duodenoscope surveillance sampling and culturing protocols. Hospitals and healthcare facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take these additional steps to further reduce the risk of infection and increase the safety of these medical devices. These protocols are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015.

Duodenoscopes are flexible, lighted tubes that are used to treat patients undergoing endoscopic retrograde cholangiopancreatography (ECRP). These procedures often are life-saving and are the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions. More than 500,000 ERCPs are performed each year in the United States. Duodenoscopes undergo a multi-step cleaning and high-level disinfection procedure called reprocessing so that they can be reused between patients. However, the complex design of duodenoscopes makes it difficult to remove contaminants compared to other types of endoscopes. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient infection.

Microbiological sampling and culturing of duodenoscopes involves sampling duodenoscope channels as well as the distal end of the endoscope and then culturing those samples with the goal of detecting bacterial contamination that may be present on the duodenoscope after reprocessing.
The FDA, CDC, ASM and other endoscope culturing experts will host a webinar on March 22, 2018, from 1-2:30 p.m. Eastern to share more about the voluntary duodenoscope surveillance sampling and culturing protocols, which can be leveraged by facilities to help monitor the quality of their reprocessing procedures. No registration is required to participate in the webinar.

El Camino Hospital Performs First U.S. Robotic Lung Cancer Bronchoscopy

April 25, 2018 — The interventional pulmonology team at the Taft Center for Clinical Research at El Camino Hospital in Mountain View, Calif., successfully performed an innovative robotic bronchoscopy procedure to view the inside of the lungs and obtain a tissue sample. This procedure, the first of its kind performed in the United States, took place as part of a clinical trial of Auris Health’s Monarch Platform. Auris recently announced U.S. Food and Drug Administration (FDA) clearance of the platform.

According to the American Cancer Society, lung cancer is the second most common cancer in both men and women. It is often the leading cause of cancer deaths in the United States, having a higher mortality than prostate, colon and breast cancers combined, according to the ACS. Approximately 220,000 people are newly diagnosed with lung cancer each year and more than 155,000 people die from the disease annually in the United States.

The early and accurate diagnosis of lung cancer is critical. Today, 90 percent of people who have lung cancer die from the disease, in part because it is often not found until the cancer is at an advanced stage. As the technology to identify lesions improves and screening for lung cancer in at-risk individuals advances, there will be increased requirements for minimally invasive diagnosis.

The Monarch Platform integrates the latest advancements in robotics, software, data science and endoscopy, with the goal of enabling earlier and more-accurate diagnosis, and eventually treatment, of small and hard-to-reach nodules in the periphery of the lung.

“At El Camino Hospital, we utilize a variety of minimally invasive procedures to visualize internal structures, obtain tissue samples and diagnose lung disease. With the use of the Monarch Platform, we are embarking on a paradigm shift in how we diagnose suspicious nodules in the lung. Since the robotic bronchoscope has the ability to travel deeper into the lung and precisely guide a biopsy instrument to even the most difficult nodules, the technology offers the potential to diagnose lung cancer at an earlier stage,” stated Ganesh Krishna, M.D., medical director of the Interventional Pulmonology Program at El Camino Hospital and fellowship director of the Interventional Pulmonary Fellowship Program in collaboration with University of California, San Francisco (UCSF) and Palo Alto Medical Foundation.

Body Vision Medical Receives FDA Clearance for LungVision Tool

May 9, 2018 — Body Vision Medical received clearance from the U.S. Food and Drug Administration (FDA) to market their LungVision Tool. The LungVision Tool is an affordable lung navigation catheter with what the company calls superb maneuverability. It is used in conjunction with standard bronchoscopes and the LungVision System to guide endotherapy accessories to small pulmonary nodules.

This approval clears the way for Body Vision Medical to accelerate commercialization efforts for its LungVision Platform for pulmonary specialists across the U.S., providing an affordable and effective real-time solution for early-stage lung cancer diagnostics and treatment procedures.

The LungVison Imaging and Navigation System was cleared by the FDA in May 2017 and has been successfully used in over 290 clinical procedures in 10 lung cancer centers across the U.S.

“Body Vision has pioneered a new generation platform for navigation bronchoscopy that applies an augmented reality approach to plan, visualize and accurately track radiolucent bronchial nodules in real time,” said Krish Bhadra, M.D., from CHI Memorial Hospital, Chattanooga, Tenn. “The LungVision navigation tool has clear performance and cost benefits over current navigation tools that are bound to electromagnetic sensing.”

The clinical experience from a multicentral study with the LungVision System will be presented at the American Thoracic Society Conference, May 18-23 in San Diego.

Olympus and Hitachi Healthcare Americas Introduce Arietta 850

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, and Hitachi Healthcare Americas, a leading company in Ultrasound and CT/MRI medical imaging, announced today an agreement in the U.S. to distribute the ARIETTA 850, a premium ultrasound processor that provides endoscopists with a greater depth of information toward improved decision making, with backing by industry-leading service and support. The ARIETTA 850, the latest introduction from a continued partnership with Hitachi Healthcare Americas, features a new OLED monitor and eFocusing technology that enhance the ultrasound image, allowing for more detailed observation. It also provides an extensive variety of imaging modalities such as Real-time Tissue Elastography and Strain Histogram Measurement, enabling a comprehensive examination. “The ARIETTA 850 premium ultrasound system expands clinical utility by offering the most advanced applications, such as elastography for GI tract diseases,” said John Waddell, senior vice president of sales and marketing for Hitachi Healthcare Americas. “Through our partnership with Olympus, these capabilities can support multidisciplinary diagnosis and treatment to achieve better outcomes.”

Endoscopic ultrasound (EUS) combines ultrasound technology with endoscopy to gain an internal vantage point for better visualization. While conventional endoscopy only provides a view of the innermost lining of the digestive tract, or its wall, the addition of ultrasound allows the physician to see beyond that wall to visualize all five layers of the GI tract as well as surrounding tissue and organs. EUS also provides a minimally invasive means for biopsy.

Olympus and Hitachi have successfully continued a long standing strategic alliance in endoscopic ultrasound and due to this continued partnership, the Olympus market leading ultrasound endoscopes continue to be compatible with Hitachi’s sophisticated ultrasound technology. Through this new introduction, the ARIETTA 850 provides U.S. customers:

  • Clinical Value: A new OLED monitor and eFocusing technology enhance the ultrasound image, allowing for more detailed observation.
  • Economic Value: Forward/backward compatibility provides lower cost of ownership and more efficient use of assets while on-site support from clinical application specialists reduces training costs.
  • Efficiency: Real-time Tissue Elastography and Strain Histogram Measurement enable a comprehensive examination.

“Our endoscopic capabilities are much expanded with the benefit of ultrasound, to diagnose and treat a range of conditions,” said Dr. David Diehl, Geisinger Health System. “We are excited that Olympus has once again partnered with Hitachi to bring us exciting advancements in image quality and technology.”

“Robust partnerships and understanding our customer needs contribute to Olympus standing at the forefront of the exciting and growing endoscopic ultrasound field,” said Kurt Heine, group vice president of the endoscopy division at Olympus America Inc. “The ARIETTA 850 is the next iteration of our commitment to stay true to quality medical device innovation that drives optimal clinical outcomes, provides a lower total cost of ownership, and enhances patient satisfaction.”

American Society for Gastrointestinal Endoscopy and Touch Surgery Pilot Video-Based Endoscopic Simulations

During the 2018 Digestive Disease Week (DDW) conference June 2-5 in Washington, D.C., the American Society for Gastrointestinal Endoscopy (ASGE), in collaboration with Touch Surgery, demonstrated three mobile-accessed and video-based simulations at ASGE’s Learning Center. Working closely with ASGE, Touch Surgery was able to convert endoscopic procedural videos into interactive mini-simulations.

Accessible from mobile devices, the simulations offer the learner the chance to walk through procedures step by step in an interactive manner. The goal of the DDW pilot was to expose members of ASGE to this mobile technology and to get their feedback about using the Touch Surgery app as a new learning modality in a convenient and scalable manner.

The pilot effort between ASGE and Touch Surgery blends two approaches to training, digital and hands-on, giving ASGE the reach of a digital platform while allowing users ongoing training options for a variety of endoscopic procedures.

The Touch Surgery surgical simulation app teaches and tests users on procedures through interactive simulations that are built from surgical videos or 3-D animations. The Learn and Test modes within Touch Surgery walk its 2.5 million users through the entire surgical procedure, giving them important feedback on steps they need to refine their knowledge in order to be ready for a clinical environment.