Innovation By Gabriel Bietz, MD, RPVI

Supporting San Antonio’s Expansion in Medical Technology Innovation

By Gabriel Bietz, MD, RPVI

San Antonio is home to over 100 early-stage medical technology and bioscience startups, all of whom are developing innovative new approaches designed to improve patient outcomes. As members of the local medical community, we have an opportunity to support these companies and colleagues by providing our input during various stages of product and clinical development. This insight is valuable to such organizations, in order to assist with moving their efforts forward through the product development phase, regulatory process and eventually, product commercialization.

Many ideas for new medical technologies are originally conceived by physicians. When I was a vascular surgery fellow at the University of Kentucky, I had the opportunity to work with Dr. John Gurley, an interventional cardiologist who was the Director of their Structural Health Program. Dr. Gurley had invented an innovative new approach to achieving central venous access in patients who had obstructions of their thoracic veins, a condition which prevented the ability to place catheters or cardiac leads. He called this procedure the “inside-out” approach. To perform the procedure, Dr. Gurley used a variety of different

devices available in his hospital to gain access through the right femoral vein, and then pass an instrument through the obstruction on the right side of the thoracic vasculature. He then passed a sharp wire through the veins and directed it externally, enabling the central venous access device to be pulled in from the outside. This life-saving approach pioneered the ability to achieve vascular access for dialysis, infusion of parenteral nutrition, antibiotics or chemotherapy, along with the placement of cardiac leads. Dr. Gurley founded Bluegrass Vascular Technologies in 2011, in order to develop and commercialize a device which would simplify performing this inside-out procedure, and therefore enable other physicians around the country to help patients with similar clinical issues resulting from venous obstructions. Coincidentally, after I left my fellowship and moved to San Antonio to join Peripheral Vascular Associates (PVA), Bluegrass Vascular received funding from a prominent local venture capital fund that invests in early-stage life science companies, and relocated their headquarters to San Antonio. In conjunction with this, the company hired Dr. Gabriele Niederauer as their CEO. Dr. Niederauer is a bioengineer and experienced medical device company executive who is a long-time resident of San Antonio. She is one of a growing number of women who are now leading both small and large medical device companies in the United States, although nationwide, only 8% of medical device company CEOs are female. Since her arrival, the company has obtained U.S. and European regulatory authorization to commercialize the Surfacer® System, a device which is specifically designed to perform the Inside-Out® procedure more quickly and efficiently, when compared to Dr. Gurley’s initial approach, which used a variety of differing devices and instruments. The hard work paid off, as a new reimbursement code was recently granted to pay hospitals and ambulatory surgery centers for the procedure. I am honored to have had the opportunity to work with Bluegrass Vascular prior to, and throughout, their product development process assisted with validating the design of their device, to help ensure it would meet the needs of clinicians who would perform the procedure. This process, termed “human factors engineering,” assessed the physical requirements, skill demands and other aspects of the environment where the device will be used to identify and address end-user associated strengths and limitations in the design of the device. The involvement of experienced clinicians is an essential factor that allows these medical device companies to ensure that the design of their innovation takes into consideration all of the factors, which may impact the safety, performance and ease of use associated with their technology. I am proud to have been a part of the process in helping Bluegrass Vascular bring their life-saving product to the market; having the ability to come full circle, from observing Dr. Gurley first using the inside-out approach during my fellowship, to now using the Surfacer System in my clinical practice at Peripheral Vascular Associates. Additionally, I am proud to support an innovative San Antonio-based medical technology company, as this also supports the efforts by local organizations and incubators to attract similar companies to the area.

Gabriel Bietz, MD, RPVI is a board-certified vascular surgeon who practices at Peripheral Vascular Associates (PVA). Dr. Bietz specializes in endovascular and minimally invasive procedures for vascular disorders and dialysis access, with expertise in using the latest treatment options for vascular disease. To learn more, please visit PVAsatx.com. Dr. Bietz is a member of the Bexar County Medical Society.