Bluegrass Vascular Technologies Presents Positive Early Results for First In Human Study
MIAMI BEACH, FL – January 22, 2013 – Bluegrass Vascular Technologies, a privately funded medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, presented initial first in human results for the Surfacer™ Inside-Out™ Access Catheter System in the poster session today at the 25th Annual International Symposium on Endovascular Therapy (ISET) in Miami Beach, FL. A total of six patients with severe renal disease and upper extremity occlusive disease were treated with 100 percent acute success rate in accessing occluded vessels, maintaining patient safety, and access patency. The results demonstrate safety, performance and efficacy of the Surfacer System. View poster here.
“We are very excited about early results of the Surfacer System first in human study. This device has the promise to revolutionize how we manage central venous access and provides a solution that allows physicians to effectively treat a very sick patient population,” said Dr. John Gurley, practicing interventional cardiologist at the University of Kentucky and the Chief Medical Officer of Bluegrass Vascular Technologies.
Approximately 6.5 million patients, worldwide, require central venous access (CVA) for medical treatment and it is estimated that more than 40% of those patients will develop a venous thrombosis, which may compromise their medical care. The current standard of care for an occluded vein is to locate another, uncompromised, venous access point. After all central veins become compromised, patients must resort to invasive surgical techniques to gain or maintain CVA. The Surfacer System maintains access in an occluded vein, halting the progression to invasive surgery.
The Surfacer™ Inside-Out™ Access Catheter System allows physicians to maintain or gain access through a previously occluded vein. The procedure consists of inserting a guide wire through the femoral vein and navigating it up through the body, using fluoroscopy, to an exit point in the jugular or subclavian vein. A standard CVC can then be placed in the occluded vessel using a standard outside-in approach. Using this novel approach extends the viability of patients’ central veins thereby prolonging their treatment, and for some patients, their life.
The Surfacer System is an investigational product and not currently commercially available.
About Bluegrass Vascular Technologies Founded in 2011 and based in Lexington, Ky., Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing life-saving devices and methods that address shortcomings in vascular access procedures. The company’s initial product offering is the Surfacer™ Inside-Out™ Access Catheter System, a proprietary system that allows physicians to perform a novel approach to gaining venous access.
Bluegrass Vascular Technologies