Mauna Kea (Paris, France) won FDA clearance for the AQ-Flex 19 miniprobe for performing optical GI biopsies with endoscopic ultrasound-guided fine needle aspiration (EUSFNA) procedures.
The already EU cleared device is 0.8mm in diameter and is compatible with compatible with all Cellvizio 100 systems.
From the announcement:
“With needle-based optical biopsies, we now have access to absolutely unique real-time dynamic views of the cellular and vascular structures of previously unreachable areas such as pancreatic cysts. While many of these lesions are benign, some cysts are pre-cancerous and even cancerous and need to be surgically removed. With current imaging and sampling techniques, it remains difficult to confirm which patient has the high risk or cancerous type of cyst and whether surgery is strongly advised,” said Kenneth J. Chang, M.D., Professor and Chief of the Division of Gastroenterology and Executive Director of the H.H. Chao Comprehensive Digestive Disease Center at the University of California Irvine, School of Medicine. “Needlebased optical biopsies may provide the missing information needed to separate the high risk vs low risk cysts and impact patient management as demonstrated by initial data generated in US and international centers, including ours. This could result in a more efficient and cost-effective way to manage these patients.”