San Antonio — [Updated 3:04 p.m. See below.] A San Antonio medical device startup called Bluegrass Vascular Technologies has received European approval to sell its system for regaining access to obstructed veins, focusing largely on patients who receive dialysis treatment for kidney failure.
The company announced today that European regulators have given the company the go-ahead, and that it has already started selling its system, called the Surfacer Inside-Out Access Catheter System, in the UK, Germany, Austria, Italy, and the Benelux countries. The company is still working with FDA regulators to seek U.S. approval.
“We are eager to commercialize the system in Europe and meet the clinical demand from physicians treating patients with occluded central veins,” Bluegrass Vascular’s CEO Gabrielle Niederauer said in a news release.
Obstructed veins are a common consequence of treatments such as hemodialysis, a procedure performed when the kidneys begin to fail and can’t remove salts, fluid, and other waste from the body, according to the Mayo Clinic. Hemodialysis filters the blood on behalf of the patient’s kidney by connecting a machine to veins either in the arm with a fistula or graft, or in the neck through a catheter.
Bluegrass Vascular’s device focuses on the veins near the neck. When physicians try to connect a catheter to a veins, veins can sometimes start collapsing, closing up, or getting blocked from being over-touched, which prevents further treatment, Niederauer said during a conversation with Xconomy earlier this year.
The device can be used to clear a path in the blocked vein, thus allowing the treatment to continue, she said. The hole-clearing tool could also help physicians connect other healthcare devices to formerly obstructed veins, such as pacemakers or a defibrillator, the company says in a video on its website.
The incidence of patients facing problems with dialysis treatment varies depending on how and where the vein is accessed, ranging from as low as 10 percent to as high as 50 percent of patients, according to one study from 2009 published in Seminars in Interventional Radiology. About 275,000 patients in Europe have some type of thrombosis or blockage that can progress to partial or fully occluded central veins, Niederauer wrote in an e-mail today. Similar numbers are true for the U.S., she says. [Paragraph updated with comments from CEO.]
Some 3.2 million patients worldwide were suffering from end-stage renal disease at the end of 2013, and about 2.5 million of those were receiving some sort of dialysis treatment, according to the European Renal Care Providers Association.
The company was founded in 2010 by John Gurley, a cardiologist at the University of Kentucky Medical Center. It received $4.8 million in financing in 2014 from Targeted Technology, the San Antonio-based life science venture capital firm. As a part of that Series A investment, Bluegrass Vascular moved to San Antonio. The company is now kicking off its Series B funding, Niederauer says. [Paragraph updated with comment form CEO.]
The device had its first clinical use on a patient earlier this year whose life was threatened because of complications from end-stage renal disease. Before the European approval, the physician was able to use the device on a patient in Germany last March because of the country’s compassionate-use program, which allows physicians to use unapproved technology if existing treatments haven’t worked, Niederauer said in April.
