Boston/Massachusetts/USA, Jena/Germany | 07 October 2017 | Carl Zeiss Meditec AG
ZEISS to present the concept of a complementary Digital Biopsy Tool for intraoperative imaging of tissue microstructures at the CNS.
At this year's meeting of the Congress of Neurological Surgeons (CNS) in Boston, Massachusetts, ZEISS Medical Technology is offering additional functionalities of ZEISS KINEVO 900 to customers in the USA after they have been granted regulatory FDA clearance: QEVO® - The Micro-Inspection Tool, and YELLOW 560 fluorescence for real-time visualization of intraoperative blood flow. In addition, BLUE 400 fluorescence has achieved registration as a Class I product. "We are delighted to see the excellent response from our customers and have never before placed this many systems in the field only months after the market launch," says Dirk Brunner, Senior Vice President of the Strategic Business Unit Microsurgery at ZEISS Medical Technology. He adds: "The very intuitive ease-of-use and the compelling design of the ZEISS KINEVO 900 has gained the recognition of several design juries." The Robotic Visualization System won the UX Design Award for its excellent user experience and the prestigious Red Dot Design Award for its product design. The new product was introduced into the market only a few months ago at the Congress of the American Association of Neurological Surgeons (AANS) in Los Angeles.
When working from the external perspective of a surgical microscope, the visualization of the anatomy is limited to a straight line of sight – potentially missing critical information behind tissue or corners. QEVO, the unique, proprietary Micro-Inspection Tool complements intraoperative microsurgical visualization, enabling neurosurgeons to discover unexplored areas during the surgical intervention without additional footprint in the OR. QEVO now allows surgeons to look around corners and eliminate blind spots, therefore providing them with greater insights – for better clinical decisions.
"I can anticipate the QEVO will be extremely useful in aneurysm surgery after clipping an aneurysm to be able to look around the corners to be sure that small perforating arteries aren’t included in the clip, the parent vessel isn’t compromised," explains Professor Daniel L. Barrow, MD, Chairman and Professor, Emory University, Department of Neurosurgery, Emory University Hospital, Atlanta, Georgia, USA. He adds: "I think in removing skull base tumors to be able to look around corners to see important neurovascular structures that may not be able to be visualized looking directly on it, will be a huge advantage."
YELLOW 560 supports doctors in the visual assessment of intraoperative blood flow in the cerebral vascular area, even in tiny vessels. This is particularly challenging in the treatment of cerebral aneurysms, vessel branch occlusions and Arteriovenous Malformations (AVM), especially in deep seated surgical cases. Fluorescence-stained structures are intraoperatively highlighted while non-stained tissue is displayed in its natural-like color. "YELLOW 560 is another good example showing how ZEISS develops innovations with leading neurosurgeons. Our goal is to provide doctors with more intraoperative information and enable them to make the right decisions during complex neurosurgical procedures," says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG, and adds: "the clearance for YELLOW 560 in the USA is an important further step."
BLUE 400, completely integrated into the ZEISS KINEVO 900 Robotic Visualization System, is now available in the USA as well. It allows to display Protoporphyrin IX fluorescence-stained structures intraoperatively in a different color. No other competitive product has proven its efficiency in a multicenter Phase III study1 like BLUE 400.
At this year's CNS, ZEISS Medical Technology will also provide insights into the development of a Digital Biopsy Tool2, which surgeons will be able to use in the future to visualize tissue microstructures during surgery. The new Digital Biopsy Tool currently being developed can be seamlessly integrated into the ZEISS KINEVO 900 Robotic Visualization System.
1Stummer W, Pichlmeier U, Meinel T et al: Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol 7: 392-401, 2006
2Caution: Investigational device, not for clinical use. Limited by law to investigational use. Not for sale. Future availability cannot be guaranteed.
Carl Zeiss Meditec AG (ISIN: DE 0005313704), which is listed on TecDAX of the German stock exchange, is one of the world’s leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. It provides complete packages of solutions for the diagnosis and treatment of eye diseases, including implants and consumable materials. The Company creates innovative visualization solutions in the field of microsurgery. With approximately 2,900 employees worldwide, the Group generated revenue of € 1,088 million in financial year 2015/16 (to 30 September).
The Group’s head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG’s shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world’s leading companies in the optical and optoelectronic industries.
For more information visit our website at www.zeiss.com/med