Having received the first US FDA Clearance for OCT Angiography technology in September 2015, the Medical Technology business group of ZEISS now announces receiving the first US FDA Clearance for Swept-Source OCT imaging technology for posterior ocular structures with ZEISS PLEX® Elite 9000. This powerful, cutting-edge Swept-Source OCT and OCT Angiography platform was designed for advanced retina research and is at the core of the Advanced Retina Imaging (A R I) Network1.
The A R I Network, led by Philip J. Rosenfeld, MD, PhD, is a unique global consortium of clinicians and scientists from around the world working at the forefront of retinal disease research. The A R I Network is focused on exploring new clinical applications for the diagnosis and treatment of eye disease and advancing OCT innovation to benefit patients today and in the future. The US FDA clearance will help US members of the A R I Network to more easily enroll patients and may facilitate faster Institutional Review Board (IRB) review for protocol approval of research.
The wide-field high-resolution visualization provided by the Swept-Source OCT and OCT Angiography imaging of the PLEX Elite platform from ZEISS expands clinicians’ ability to examine the critical microstructures and microvasculature of the posterior segment at any depth of interest from vitreous to sclera.
“ZEISS’ Swept-Source OCT and OCT Angiography platform is truly a remarkable breakthrough in our quest to achieve better, wider, deeper, and faster imaging of the retina and choroid. This instrument opens up a new world of structural and microvascular clarity. By imaging deeper and in greater detail than ever before, we will further our understanding of the retina and choroid, and greatly facilitate clinical trial investigations into different diseases,” says Dr. Rosenfeld, Chairman of the A R I Network. “This collaboration between the retina experts in the A R I Network and the engineers and scientists at ZEISS is vital to the advancement of retinal and choroidal imaging and scientific discovery.”
“The A R I Network is unique in that it promotes innovation through collaboration,” says Jim Mazzo, Global President Ophthalmic Devices for Carl Zeiss Meditec. “Through the active exchange of ideas and findings, the A R I Network is driving not only the development of new clinical applications but is helping to accelerate innovation development to advance clinical practice and patient care.”
ZEISS PLEX Elite 9000 offers researchers the potential to assess early mechanisms for micro- and neovascularization, to explore the progression of retinal and choroidal pathology, to deepen the understanding of choroid physiopathology, and to evaluate mechanisms of retina and choroid response to therapy.
ZEISS PLEX Elite 9000 Swept-Source OCT and OCT Angiography platform has a limited release as a research tool for clinicians conducting retina research. The latest technology for daily comprehensive care, ZEISS AngioPlex™ OCT Angiography is available on the CIRRUS™ HD-OCT 5000 platform allowing ophthalmic practices to easily integrate advanced vascular imaging into their routine OCT diagnostic exams. The full complement of capabilities for CIRRUS OCT gives practices a broad spectrum of clinical analysis for patients with various chronic eye diseases.
1 ZEISS PLEX Elite 9000 and the Advanced Retina Imaging Network limited to select markets.