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Vycor Medical, Inc. Announces the First Pediatric Report Published in the Journal of Neurosurgery: Pediatrics

Thursday, June 2, 2011 General News J E 4
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BOCA RATON, Fla., June 1, 2011 /PRNewswire/ -- Vycor Medical, Inc. announces the latest published peer-reviewed article "Use of a minimally invasive tubular retraction system for deep-seated tumors in pediatric patients" by the Journal of Neurosurgery: Pediatrics.  The Journal is an international, peer-reviewed neurosurgical journal, published by the American Association of Neurological Surgeons. The authors of the article include Pablo F. Recinos, M.D., Shaan M. Raza, M.D., George Jallo, M.D., and Violette Renard Recinos, M.D. – affiliations include, Division of Pediatric Neurosurgery, Johns Hopkins University School of Medicine, and the Department of Neurosurgery, Cleveland Clinic Foundation. This retrospective study of 4 pediatric cases (ages 15 months, and 9, 10, and 16 years) utilizes Vycor's ViewSite™ Brain Access System (VBAS), a minimally invasive tubular brain access/retractor system specifically designed for cranial applications. According to the authors, "Microsurgical resection is the preferred treatment for most deep-seated, intra-axial tumors in the pediatric population. The feasibility of surgery as an option has improved with advances in surgical technology and techniques." The goal of the report was to obtain and evaluate the surgical approach using the VBAS in resecting or obtaining biopsies of deep lesions in the brain. The authors of the study describe their experience with VBAS in combination with frameless neuronavigation.

This study is the first documented report on a small series of pediatric patients using Vycor's ViewSite™ Brain Access System. The 4 patients underwent surgery for removal or excisional biopsy of deep-seated lesions, a treatment notably challenging and previously considered to be inoperable. While the study highlights several key advantages the VBAS has over previous designs of tubular retractors such as: the clear plastic material prevents electrical transmission and allows for better visualization.  However, the emphasis is on the minimally invasive aspect of the device as it separates the tissue as opposed to dissection, resulting in less tissue manipulation that should enhance patient outcome.  The ability for it to be easily used with frameless neuronavigation replaces the need for frame-based neuronavigation. Although, further studies are suggested in larger series focusing on surgical outcomes, the authors do report optimistic results and state the use of the VBAS with frameless neuronavigation facilitated the surgical approach.  

"Aiding the surgeon to reach targets deep in the brain for safe microsurgery is extremely significant especially for pediatrics cases since the life expectancy can be long if a complete cure is achieved," says Kenneth Coviello, CEO of Vycor Medical. "We are extremely pleased with the results of the report and believe it supports our primary design goals of safely approaching deep-seated targets in the brain in a minimally invasive manner."

Vycor's ViewSite Brain Access System has FDA clearance and is available in 12 sizes.  The elliptical optically clear port with a specially designed introducer is intended to separate brain tissue allowing the neurosurgeon to access deep targets within the brain. Once they have reached the desired target the introducer is removed and the surgeon can use standard instruments through the ViewSite working channel.

A copy of the full report with pictures can be ordered at: http://thejns.org/doi/abs/10.3171/2011.2.PEDS10515

About Vycor Medical, Inc.

With corporate headquarters in Boca Raton, FL, Vycor Medical, Inc. (VYCO.BB) is a medical device company committed to making neurological brain, spinal and other surgical procedures safer and more effective.  The company's flagship, patent pending ViewSite™ Surgical Access System (VBAS) represents an exciting new minimally invasive access and retraction system that holds the potential for speedier, safer and more economical brain, spinal and other surgeries.  Vycor's VBAS offers the advantage of being able to be used in conjunction with neuronavigational systems to optimize neurosurgical site access, decrease the potential risks of the surgery, and minimize tissue manipulation, all of which should lead to enhanced patient outcome and possible earlier release from the hospital. Some surgeons have even noted the ability to perform procedures that might not have otherwise been accomplished.  Vycor is ISO 13485:2003 compliant, has FDA 510(K) clearance for brain and spine surgeries, and CE marketing and HPB licensing in Canada. In December of 2010 the company purchased the assets of NovaVision Inc.  (www.novavision.com). NovaVision's Vision Restoration Therapy ("VRT") is an FDA cleared, patented, non invasive medical device that helps to improve vision in stroke or traumatic brain injuries (TBI) patients with visual deficits. Potential visual field deficits include (but are not limited to) hemianopia, quadrantatnopia, and scotoma.

Safe Harbor Statement

Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast," "anticipate," "estimate," "project," "intend," "expect," "should," "believe," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Vycor Medical's actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Vycor Medical's filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Vycor Medical herein are expressly qualified in their entirety by the abovementioned cautionary statement. Vycor Medical disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.

Contact:Karen Coviellokacoviello@novavision.com323.387.9555

SOURCE Vycor Medical, Inc.

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