Data from the study was presented at the 2017 American Thoracic Society’s International Conference.
The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said.
Results from follow-up exams of 24 lung transplant patients were used in the study, with CLE video-imaging obtained prior to tissue sampling, Mauna Kea said. Endomicroscopy video-images from the Cellvizio were blindly reviewed by 4 pulmonologists independently and then with a consensus meeting.
Reproducibility was assessed by calculating IntraClass Correlation Coefficient and Fleiss Kappa before and after the consensus meeting, with scores of 0.77 and 0.39 respectively pre-consensus, and 0.96 and 0.77 post-consensus.
Study results indicated that perivascular cellularity observed with Cellvizio “provides a feasible and reproducible criterion to assess acute lung rejection in vivo,” according to a press release.
“Probe-based Confocal Laser Endomicroscopy represents a potential new tool to provide a less-invasive diagnosis of acute lung rejection in lung transplant recipients requiring trans-bronchial biopsies. The results from our study suggest that pCLE could potentially save patients from unnecessary invasive biopsies. We look forward to further studying this endomicroscopy application in order to better enhance the treatment continuum for lung transplant patients,” Dr. Cesar Keller of Jacksonville, Fla.’s Mayo Clinic said in prepared remarks.
“This study provides further evidence of the broad potential of the Cellvizio platform to improve diagnostic and treatment outcomes. We thank Dr. Keller and his colleagues for conducting this unique study sponsored by Mauna Kea Technologies and demonstrating that with proper training, the procedure is effective and reproducible. We are optimistic that Cellvizio will increasingly be used in a variety of applications that can benefit from its unique ability to provide real-time diagnostic information at the cellular level. Moreover, image interpretation automation with artificial intelligence will contribute to the performance and adoption of Cellvizio in this and other applications,” CEO & founder Sacha Loiseau said in a press release.
In April, Mauna Kea released data from the National French Registry on Cellvizio procedures, touting strong performance of its confocal laser endomicroscopy in diagnosing major gastrointestinal diseases when compared to historical findings.
The results were presented at the Meeting on Hepato-Gastroenterology and Digestive Oncology in Paris.