Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeMauna Kea TechnologiesMauna Kea Technologies: Largest Cellvizio Study To Date Demonstrates Near Perfect Correlation...

Mauna Kea Technologies: Largest Cellvizio Study To Date Demonstrates Near Perfect Correlation with Histology in Key GI Procedures

Cellvizio histologic correlation above 90% for Barrett’s Esophagus, Biliary Strictures, and Pancreatic Cysts procedures Presentation of data covering 399 cases from National French Registry announced in oral presentation at 2017 Annual French-speaking Meeting on Hepato-Gastroenterology and Digestive Oncology

April 3, 2017

Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced the presentation of data from the National French Registry on Cellvizio® procedures confirming the strong performance of confocal laser endomicroscopy (CLE) in the diagnosis of major gastrointestinal diseases as compared to histological findings.

Mauna Kea Technologies notes the registry outcomes1 were disclosed in an oral presentation during the Annual French-speaking Meeting on Hepato-Gastroenterology and Digestive Oncology on March 24, 2017 in Paris (JFHOD 2017).

The Cellvizio National French Registry is a post-market observational study sponsored by the French National Digestive Endoscopy Society (SFED). The presentation at JFHOD 2017 meeting covered data from 399 prospective CLE-procedures performed between September 2013 and February 2015 at 12 participating endoscopy centers. Overall imaging quality was ranked as good in 83% (331/399) of the cases, bad in only 1% (4/399) and correlation factor with histology (Kappa) was equal or greater than 0.90 in the following 3 key indications:

  • Barrett Esophagus Detection and Follow-up (28% of the registry cases), Kappa was 0.90 for the differentiation of normal tissues, inflammatory, metaplasia and dysplastic lesions; Cellvizio allowed real time biopsy guidance or impacted immediate therapeutic decision in 84% of the patients
  • Biliary Strictures Characterization (11% of the registry cases), Kappa was 0.94 for the differentiation of normal tissues, inflammatory, high-grade dysplastic lesions or carcinoma ; Cellvizio allowed real time biopsy guidance or impacted immediate therapeutic decision in 90% of the patients
  • Pancreatic cysts Characterization (30% of the registry cases), Kappa was 0.93 for the differentiation of serous cysts, mucinous cysts, IPMN, pseudocysts or neuroendocrine tumor; Cellvizio allowed real time diagnosis and impacted immediate therapeutic decision in 80% of the patients. More rare cases have been observed (lymph nodes, pancreatic masses, ampullomas …) in 10% of the patients.

The remaining indications were gastritis follow-up in 5% of the patients, characterization of colorectal polyps in 11% and detection of dysplastic lesions in inflammatory bowel diseases in 5% with respective Kappa value of 0.78, 0.70 and 0.82.

One serious adverse event without consequence was reported but was not linked to the Cellvizio device.

Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, commented, “We are proud to have supported the SFED in this endeavor. The results from this large, comprehensive and independent national registry confirm the expansion and ease of use of our technology, the quick adoption and learning curve, and the safety and the strong correlation of the Cellvizio procedure with histological and pathological findings. Cellvizio clearly allows gastroenterologists to make real-time therapeutic decision for improved patient management. The results from this registry will provide an important data point in our efforts to secure reimbursement for Cellvizio in France.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy