cellvizio is an endomicroscopy system which generates ...what is gerd? what is cellvizio® &...

2
Cellvizio®, very clearly, is integral to the comprehensive assessment of patients suffering from reflux diseaseAmerican Society of General Surgeons Position Statement - 2016 “I needed to make sure that I was giving a thorough examination to [GERD] patients. Cellvizio is the most effective and precise tool to detect these signs” Dr Danbert, Gastroenterologist, Texas Cellvizio® for GERD patients Cellvizio is an endomicroscopy system which generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Indicated for the identification of cells and vessels and their organization or architecture, this may facilitates better decision-making and improved patient management. I have Chronic Acid Reflux Get Answers Fast with Cellvizio® The Cellvizio® Systems are regulated Medical Devices, CE marked (Class IIa - NB : LNE/G-MED) and FDA cleared; Cellvizio 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. These statements and the associated references to specific clinical studies, are not intended to represent claims of safety or effectiveness for detecting or treating any specific condition or disease state. Rather this information is intended to provide useful reference to selected published literature describing physician experiences with the associated clinical uses. These statements have not been reviewed, cleared, or approved by the U.S. FDA. Any diagnostic assessment should always be made by the attending physician, based on the evaluation of all sources of clinical, endoscopic and other relevant information. Effectiveness of Cellvizio varies based on physician skill and experience. MKT-901-US-rev001 © Mauna Kea Technologies 2018 24 Denby Road, Suite 140 - Allston, MA, USA Tel : +1 (617) 657 1550 - Toll free : + 1 (888) 590 1798 Fax : +1 (888) 797 6640 - maunakeatech.com Barrett’s esophagus Bilio-pancreatic strictures Pancreatic cysts Colorectal lesions Inflammatory bowel diseases Gastric lesions

Upload: others

Post on 06-Oct-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Cellvizio is an endomicroscopy system which generates ...What is GERD? What is Cellvizio® & Endomicroscopy? Why do I need it? Esophageal Cancer is the fastest growing cancer(1) but

“Cellvizio®, very clearly, is integral to the comprehensive assessment of patients su� ering from refl ux disease”American Society of General Surgeons Position Statement - 2016

“I needed to make sure that I was giving a thorough examination to [GERD] patients. Cellvizio is the most e� ective and precise tool to detect these signs”Dr Danbert, Gastroenterologist, Texas

Cellvizio® for GERD patientsCellvizio is an endomicroscopy system which generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Indicated for the identifi cation of cells and vessels and their organization or architecture, this may facilitates better decision-making and improved patient management.

I have Chronic Acid Reflux

Get Answers Fast

with Cellvizio®

The Cellvizio® Systems are regulated Medical Devices, CE marked (Class IIa - NB : LNE/G-MED) and FDA cleared; Cellvizio 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fi ber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identifi cation of cells and vessels and their organization or architecture. These statements and the associated references to specifi c clinical studies, are not intended to represent claims of safety or e� ectiveness for detecting or treating any specifi c condition or disease state. Rather this information is intended to provide useful reference to selected published literature describing physician experiences with the associated clinical uses. These statements have not been reviewed, cleared, or approved by the U.S. FDA. Any diagnostic assessment should always be made by the attending physician, based on the evaluation of all sources of clinical, endoscopic and other relevant information. E� ectiveness of Cellvizio varies based on physician skill and experience.

MK

T-9

01-

US

-rev

00

1 © M

auna

Kea

Tec

hno

log

ies

2018

24 Denby Road, Suite 140 - Allston, MA, USATel : +1 (617) 657 1550 - Toll free : + 1 (888) 590 1798Fax : +1 (888) 797 6640 - maunakeatech.com

Barrett’s esophagus

Bilio-pancreatic strictures

Pancreatic cysts

Colorectal lesions

Infl ammatory bowel diseases

Gastric lesions

Page 2: Cellvizio is an endomicroscopy system which generates ...What is GERD? What is Cellvizio® & Endomicroscopy? Why do I need it? Esophageal Cancer is the fastest growing cancer(1) but

1. The Wall Street Journal - Emerging Type of Heartburn Defi es Drugs, Diagnosis Sharma P. et al. Real-time Increased Detection of Neoplastic Tissue in Barrett’s Esophagus with probe- based Confocal Laser Endomicroscopy: Final Results of a Multi-center Prospective International Randomized Controlled Trial. Gastrointestinal Endoscopy, 2011 (DONT BIOPCE). 2. Webcontent contribution from the College of American Pathologists website. 3. Sharma P. et al. Real-time Increased Detection of Neoplastic Tissue in Barrett’s Esophagus with probe- based Confocal Laser Endomicroscopy: Final Results of a Multi-center Prospective International Randomized Controlled Trial. Gastrointestinal Endoscopy, 2011. 4. Bertani H. et al. Improved Detection of Incident Dysplasia by pCLE in a BE Surveillance Program. Dig Dis Sci, 2013.

What is GERD? What is Cellvizio® & Endomicroscopy?

Why do I need it?

Esophageal Cancer is the fastest growing cancer(1) but patients can be cured when it is caught at an early stage.

To try to diagnose the disease, a physician will visualize your esophagus with an upper endoscopy and take biopsies. These biopsies would then be read by a pathologist.

Unfortunately, current biopsy protocols are a shotgun approach to detection. The rate of detection can be low and many unnecessary biopsies are taken(2).

Benign, pre-cancerous and cancerous lesions are often indistinguishable from each other upon endoscopy alone, unless viewed at the cellular level.

Ideally, physicians want to be able to diagnose or rule out a problem during an examination, and then treat the problem as fast as possible without the need to come back for a separate procedure.

Gastroesophageal refl ux disease (GERD) is a very common disease occuring at the junction between the stomach and the esophagus. It refers to the back-fl ow of stomach contents into the esophagus.

If tissue damage is present, GERD can evolve into a more severe stage, such as Barrett’s Esophagus and up to cancerous lesions.

Endomicroscopy is a state-of-the-art technique for looking inside the body using a probe-based live microscope (pCLE).

Cellvizio® magnifi es the tissue up to 1,000 times. This information allows physicians to assess the tissue in real time and, if necessary, target biopsies.

Cellvizio® has been adopted by leading physicians around the world. Independent clinical studies have reported success in using Cellvizio® for the screening and surveillance of patients with GERD.

The Cellvizio® technology can be used to assess tissue of the esophagus during an upper endoscopy procedure.

Clinical studies have shown that adding Cellvizio® to GERD evaluation can help your physician:

immediately detect the presence of your disease. This can possibly lessen the length of time to an accurate diagnosis.

reduce the number of biopsies needed while increasing diagnostic yield(3,4). Patients are better served if the biopsies can be targeted(2). This could allow you to expedite a treatment plan.

Learn more on GERD, Barrett’s Esophagus & Esophageal Cancer

diagnosingbarretts.comecan.org

CONSULT YOUR PHYSICIAN OR HEALTHCARE PROFESSIONAL TO DETERMINE IF CELLVIZIO® IS RIGHT FOR YOU.

Understand your disease state

Cellvizio® exam

Mucosa tissueEndoscopic image

Living cellpCLE image