Vycor Medical, Inc., a provider of innovative and superior surgical and therapeutic solutions, announced that it had successfully completed the development of new prototypes of its patented ViewSite Brain Access System ("VBAS") device that will be fully compatible with selected image-guided systems. The device has been specifically designed to house the pointer utilized in image-guided systems. The pointer will be firmly held in place in the introducer through a novel approach while the working channel will remain unchanged. The Company will now commence the testing of these devices. Initially the Company plans on manufacturing four new devices targeted at this market, this development being spurred by strong neurosurgeon demand. VBAS is currently approved in over 170 hospitals in the U.S. and more than 6,500 surgeries have been performed worldwide utilizing VBAS.
VBAS is a suite of clear cylindrical disposable devices used to access target sites such as tumors within the brain, which provides a working channel during neurosurgery for their removal. The devices are being used in brain surgeries in the US and internationally. The company is ISO 13485:2003 compliant, has U.S. FDA 510(k) clearance for brain and spine surgeries and full regulatory approvals for brain in Australia, Canada, China, Europe (EU - Class III), and Japan and is seeking or has partial regulatory approvals in Brazil, India, Korea, Russia, Taiwan and Vietnam.
The VBAS system provides a minimally invasive approach into the brain, offering clinical advantages that have been validated in various peer-reviewed articles and have enabled previously inoperable procedures to take place, thereby saving and changing lives. The product's minimally invasive profile and clinical superiority has been documented in five studies including peer-reviewed articles by surgeons at leading institutions including Cleveland Clinic (Pediatrics Department), Johns Hopkins University, Ohio State University and University of Illinois at Chicago. Additional studies are anticipated in the near future further supporting the products clinical benefits.
Traditional tools for brain access and retraction have not changed much in more than 50 years. Advantages of the innovative Vycor VBAS over the long-established standard of care device, the "blade retractor," include:
Provision of a minimally invasive approach into the brain which results in reduced "white matter" damage to the surrounding tissue and is likely to lead to improved surgical outcomes for patients Improved visibility for the surgeon due to the VBAS transparent tubular form Stable working channel and more accurate target access Reported to result in reduced surgical time which results in lower total costs of procedures Has been reported to have been used in procedures that were otherwise considered to have been inoperable using existing standard retractors
A corporate video on the whole of the Vycor Group, which highlights VBAS and includes commentary from several neurosurgeons, can be found at: Vycor Corporate Video
Commenting on the completion of the new prototype work, Peter Zachariou, Chief Executive Officer of Vycor, stated, "Vycor's mission is to develop devices which address a significant need and provide innovative neurosurgical solutions. Working with surgeons and other partners we believe this new fully IGS-compatible suite of VBAS devices will further revolutionize the way in which surgeons perform brain surgery and will assist Vycor in its goal of making the VBAS device the 'Standard of Care' for brain retraction and access."