Vycor Medical Inc. 951 Broken Sound Parkway, Suite 320 Boca Raton, FL 33487, United States

+1-561-558-2020

Regulatory

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Regulatory Downloads:

Declaration of Conformity

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ISO 13485:2016 and MDSAP Certificate

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VBAS EC Design Examination Certificate

PDF Version

VBAS EC Certificate Full Quality Assurance System

PDF Version

EU Notified Body Certificates Extension Letter

PDF Version

VBAS FDA 510(k) Clearance Letter

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Canadian License Issued to Vycor Medical Inc

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Testimonials

Ricardo J. Komotar, MD, FAANS, FACS

Department of Neurological Surgery University of Miami School of Medicine

“The ViewSite Brain Access System (VBAS) is a game-changing device. It allows neurosurgeons to safely access and effectively remove deep-seated tumors. I routinely incorporate this technology into my practice when dealing with subcortical metastases and gliomas, as well as intraventricular lesions such as colloid cysts, central neurocytomas, and septal gliomas. VBAS provides a minimally invasive approach with excellent visualization and bimanual surgical technique through a boutique small incision, less pain, and faster recovery.”

Kyle Smith, MD

General Neurosurgeon Semmes Murphey Clinic

“Vycor VBAS is a great minimally-invasive option for deep-seated lesions and intraventricular cases as it reduces local retraction-related ischemia and pressure while providing a great visual working window. For neurosurgeons versed in MIS spine tubular retractors, VBAS is the brain corollary and is an easy transition. Additional potential improvements with navigation and robotics make this system hugely versatile.”

Dimitris G. Placantonakis, MD, PhD

Associate Professor of Neurosurgery NYU Grossman School of Medicine
“I have been using the VBAS system to remove deep-seated brain tumors for several years now and have been very pleased with the results. In such cases, I rely on tractography to identify the best possible trajectory to the target. Being able to select the tube of the appropriate diameter and length for each case is a huge plus. VBAS has allowed me to do surgeries that would have otherwise been impossible.”

Konstantin V. Slavin, MD

University of Illinois at Chicago Illinois
"Transparent tubular retractors provide unique means of deep visualization and even force distribution at the retracted brain tissue. Although the VYCOR tubular retractors are originally designed for removal of deep subcortical tumors, we have used them to access and evacuate intracerebral hematomas on several occasions. At the end, I and my team of residents were pleased to discover the ease of use and unique visualization and illumination of the surgical field that they deliver. The tubular nature of the retractor allows one to rotate it and change the angle of the approach without putting extra pressure on the brain tissue that inevitably occurs when using malleable or any other ribbon-type retractors."

Donald M. O’Rourke, MD

Associate Professor, Department of Neurosurgery University of Pennsylvania
“Brain retractors were first designed for microneurosurgery, primarily for vascular lesions where elevation of the brain is critical for surgical treatment. The Vycor Brain Access Retractor System is a major advance in brain retraction for intracranial tumors where lesion isolation within the brain substance is top priority. A single tubular retractor isolates pathology easily with excellent lighting. The brain is retracted with equal pressure around the isolated lesion margin. The retractor can be easily used with frameless stereotactic systems and is remarkably easy to reposition during tumor resections. I believe the Vycor system is a much-needed upgrade to preexisting retractor systems, particularly for resection of intraaxial tumors.”

David J. Langer, MD

Director of Cerebrovascular Surgery North Shore LIJ

“Brain retractor options have remained essentially unchanged for many years. I began using tubular retractors primarily designed for spinal surgery on select cranial procedures a few years ago to improve visibility, limit brain retraction and injury and improve ease of tumor removal. The Vycor retractor is an idealized version of this concept and I believe represents an outstanding retractor option for many intrinsic brain tumors and intra-ventricular lesions”.

Ramin Rak, MD

“In my experience, I like the VBAS for brain surgeries, mainly with microsurgical techniques for primary or metastatic brain tumor resections. It allows me not only to approach the tumor with minimal retraction but also with a degree of accuracy and safety as it allows me to visualize surrounding gray and white matter. I have experienced less brain edema post-operatively in my patients. This has helped to some extent with a faster discharge for the patients”.

Henry H. Woo, MD

Director, Cerebrovascular Center Stony Brook University Medical Center
“In my experience, I like the VBAS for brain surgeries, mainly with microsurgical techniques for primary or metastatic brain tumor resections. It allows me not only to approach the tumor with minimal retraction but also with a degree of accuracy and safety as it allows me to visualize surrounding gray and white matter. I have experienced less brain edema post-operatively in my patients. This has helped to some extent with a faster discharge for the patients”.

Michael W. Weaver, MD

“The Vycor ViewSite Brain Access System is a unique retractor system that is ideally suited to minimize brain retraction during surgical resection of deep seated subcortical or ventricular lesions”.