Vycor Medical, Inc., a provider of innovative and superior neurosurgical and neurotherapeutic solutions, today announced continued momentum and an increase in the number of hospitals that have approved use of Vycor's patented ViewSite™ Brain Access System ("VBAS") device. During this calendar year, VBAS has been approved by 12 new U.S. hospitals and is now approved in more than 170 hospitals in the U.S. with additional hospitals going through the approval process. To date, more than 5,000 surgeries have been performed utilizing VBAS.
David Cantor, President of Vycor, commented, "Neurosurgeons continue to demand the VBAS system to treat their patients, helping us to expand our global market presence. The patented, innovative VBAS product continues to gain traction in both the U.S. and international markets and we remain convinced that the VBAS device will become the 'Standard of Care' for brain retraction and access."
VBAS is a suite of clear cylindrical disposable devices used to access target sites such as tumors within the brain which provide a working channel during neurosurgery for their removal. The devices are being used in brain surgeries in the U.S. 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 India, Korea, Russia, Taiwan and Vietnam. Vycor has 8 granted and 8 pending patents worldwide.
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 leading institutions including John's Hopkins University, University of Illinois at Chicago, and the Cleveland Clinic (Pediatrics Department). Additional studies are anticipated in the near future further supporting the products clinical benefits.
Traditional tools for brain 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 due to the products tubular shape. VBAS applies rigid, constant and equally distributed pressure to the surrounding tissue. The tubular retractor provides enhanced visualization and more stable retraction of the surrounding tissue. Reported to result in reduced surgical time which results in lower costs of procedures and improved surgical outcomes for patients.