In 2010, there were approximately 202 million people affected by peripheral vascular disease [3]. In 2013, this disease resulted in approximately 41,000 deaths [4]. Entirely understanding this disease can allow biomedical engineers to develop a biomedical product or device to help prevent the increasing toll of deaths that occur annually due to this disease. W.L. Gore has been developing a product for the past 20 years to help alleviate pain and extend life for patients affected by peripheral vascular disease to help promote a higher quality of life. The W.L. Gore VIABAHN Endoprosthesis was first introduced in Europe in 1996. Not until 2002 was the device first introduced in the United States. In 2003, the device was finally introduced for deployment on 6-8 mm devices and in 2005, the FDA approved the inclusion of this device for superficial femoral artery …show more content…
Gore’s VIABAHN Endoprosthesis with Heparin Bioactive Surface devices, there are many risks that are included throughout the process. There can be implications at the insertion site, normally through the femoral artery of the groin area, or in the hemodialysis access area that is intended to be treated. Some of the critical risks that need to be avoided include hematomas, occlusion – the complete blockage of the blood flowing through the device or vein, device embolism – movement of the device to a non-intended implantation site, or allergic reaction to the x-ray dye being using during surgical implantation. Some of these may not be able to be prevented for the next couple of years, or until technological advances in bioengineering are discovered, but some of these risks can be mitigated with proper improvements to W.L. Gore’s VIABAHN Endoprosthesis device. Some improvements that can be made to this device are coating the catheter with more of a biocompatible material to prevent any inflammation throughout the surgical procedure and introduction of the endoprosthesis stent. This could help reduce the amount of bruising that occurs and also prevent some form of thrombosis during this part of the surgical procedure. Further contradictions to the current innovations of this device include lesions or affected areas that are inoperable or are not affected by the design of this device. This includes situations when