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Cellvizio

Product catalog summary

Overview: The Cellvizio® brochure provides an in-depth look at the use of Confocal Laser Endomicroscopy (CLE) in gastroenterology, highlighting its applications in diagnosing and managing various gastrointestinal conditions. The document emphasizes the advantages of real-time cellular-level imaging in improving diagnostic accuracy and patient outcomes.

Key Sections:

1. Confocal Laser Endomicroscopy (CLE): CLE is presented as a revolutionary tool that enhances traditional endoscopy by providing microscopic analysis of tissues in real-time. This technology is particularly useful in the gastrointestinal tract, allowing for more precise diagnoses.

2. Pancreatic Cysts: The brochure discusses the challenges in diagnosing pancreatic cysts, noting that traditional methods often leave cysts indeterminate. CLE, particularly needle-based confocal laser endomicroscopy (nCLE), improves specificity in identifying mucinous cysts and serous cystadenomas, reducing unnecessary surgeries.

3. Biliary Strictures: CLE is shown to enhance the diagnostic process for biliary strictures, which often remain indeterminate after ERCP. The use of probe-based CLE (pCLE) can reduce the number of procedures needed and increase confidence in ruling out malignancies.

4. Barrett’s Esophagus: The document highlights the inefficiencies of random biopsies in detecting neoplasia in Barrett’s Esophagus. CLE increases diagnostic yield and can reduce the number of biopsies needed, aiding in better treatment planning and follow-up.

5. Colorectal Lesions and IBD: CLE assists in the real-time assessment of colorectal lesions and inflammatory bowel disease (IBD), allowing for immediate and complete endoscopic resections and better disease management.

6. Clinical Studies and Efficacy: Various studies are cited throughout the brochure, demonstrating the increased sensitivity and specificity of CLE in different gastrointestinal applications. These studies support the integration of CLE into standard practice to improve diagnostic accuracy and patient care.

7. Global Reach and Training: The brochure notes the widespread adoption of Cellvizio systems in over forty countries and highlights the availability of training and educational resources for healthcare professionals.

Conclusion: The Cellvizio® systems, with their advanced imaging capabilities, represent a significant advancement in gastroenterology, offering enhanced diagnostic precision and potentially better patient outcomes. The brochure underscores the importance of integrating CLE into routine clinical practice to address the limitations of traditional diagnostic methods.

Catalog excerpts

CONFOCAL LASER ENDOMICROSCOPY (CLE) Cellvizio Cellvizio GI Brochure INT © Mauna Kea Technologies, May 2016, v1.01 provides real-time vision at the cellular level HD White Light Endoscopy X 30 MACROSCOPIC ANALYSIS Histology BIOPSY: MICROSCOPIC ANALYSIS Cellvizio MINIPROBE

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PANCREATIC CYSTS Over 50% of cysts are missing cytological conﬁrmation1 1 out of 5 cysts remains indeterminate after EUS1 Cytology misses half of the mucinous cysts, and CEA levels overlap yielding unspeciﬁc result1 4 out of 10 patients with benign pancreatic cysts undergo unnecessary surgery due to uncertain diagnoses2 Repeat EUS-FNA procedures are required ADDING nCLE TO STANDARD PRACTICE CAN HELP: º Improve characterization for indeterminate cysts3-5 º Conﬁrm the EUS impression, when cytological conﬁrmation is missing3-5 Clinical studies have shown that nCLE provides on-the-spot characterization...

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BILIARY STRICTURES 60%+ Over 60% of patients remain histologically indeterminate after ERCP6 CONSEQUENCE © Up to 3 ERCP procedures may be required to obtain a diagnosis7 © 15-24% of surgical resections for suspected biliary malignancy reveal benign etiologies8,9 15-24% benign etiology after surgery O Rule out cancer with more confidence for strictures that appear benign6 O Document a malignant ERCP impression, when tissue sampling comes back indeterminate1 Clinical studies have shown that pCLE reduces the number of patients with indeterminate strictures after ERCP1 82% NPV of ERCP with tissue...

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BARRETT'S ESOPHAGUS 6% Inefficient random sampling with a low diagnostic yield at 6%15 ? ■ Limited insight on the choice of treatment modality and on the completeness of treatment CONSEQUENCE © Increased patient anxiety & procedural costs © Treatment delay © Recurrence and residual dysplasia Clinical studies have shown that pCLE increases the diagnostic yield of procedures Biopsies can be avoided for 60% of patients18 (When WLE, NBI and pCLE all look normal) Intestinal metaplasia 76% Sensitivity of pCLE with WLE or NBI DONT BIOPCE study, 101 patients, multi-centric16 GastroFlex™ UHD Miniprobe...

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Drugs prescription and dosage 25% of patients with colorectal lesions show residual or recurring neoplasia at follow-up post EMR11 Drugs for inﬂammatory bowel diseases are prescribed and escalated based on symptoms only but the dosage is hard to adapt on symptoms alone13 Patients must await results of follow-up biopsies before potentially returning for additional EMR if needed Increased medication, pain and anxiety for the patient ADDING pCLE TO STANDARD PRACTICE CAN HELP: º Assess in real-time the extent of a ﬂat lesion, allowing immediate and complete endoscopic resection in a single procedure11...

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CELLVIZIO WORLDWIDE in more than forty countries 800+ Peer reviewed publications on endomicroscopy Cellvizio® Academy Cellvizio® in Gastroenterology Barrett's esophagus Bilio-pancreatic strictures Pancreatic cysts O A dedicated training website: cellvizio.net You have chosen Pancreatic cysts Colorectal lesions O Educational events around the world, led by endomicroscopy experts NORTH AMERICA ASIA Mauna Kea Technologies, Inc. Mauna Kea Technologies China 185 Alewife Brook Parkway, Suite 215 Office 30, 26F, Tengfei Plaza Cambridge, MA 02138, No. 333 Tianyaoqiao Rd, Tel : +1 (678) 731 7544...

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