Local Medical Device Firm Gets FDA OK After Years-Long Regulatory Slog

Bluegrass Vascular Technologies announced Tuesday it has received U.S. Food and Drug Administration approval for its novel catheter system for kidney dialysis patients, ending the locally headquartered medical-device firm’s five-year period of waiting for the federal go-ahead. 

Bluegrass’ catheter system has been granted a De Novo classification order, meaning the new device is now authorized to be marketed in the U.S. so long as it stays in compliance with regulatory controls, according to the FDA’s website. A De Novo classification means a device is so novel, there is no comparable existing device, explained Bluegrass CEO and President Gabi Niederauer. 

The system allows medical professionals to reach large veins for hemodialysis through the femoral artery in the thigh, should a patient’s veins in typical access points – such as in the neck – collapse and become unavailable. 

To see the product now entering the American market is exciting for Bluegrass, Niederauer said. However, the product took such a long time to get approved due to the complexity of the FDA’s system, she added.

Dr. John Gurley,  a researcher at the University of Kentucky who founded Bluegrass in 2011, developed the technology. Niederauer took over the Kentucky-based company in 2014 and said it’s since been her goal to get the product into the public market.

The system will enter the U.S. market in the coming months, according to a statement released by Bluegrass. The firm is still working on finalizing a price tag on the system, Niederauer said. 

“Now we’re looking at how to get this product to interested physicians,” Niederauer said. “We’re focusing on getting the product launched and getting an application filed with the [Centers for Medicare and Medicaid Services].”

“We started engagement with the FDA nearly five years ago, so we’re really excited to get the U.S. approval to make this available to patients here,” she added.

When Bluegrass first sought approval in 2015 for the system it was denied because there were no other devices like it, Niederauer said. This put the product on the De Novo path, which required additional clinical studies, she said.

The product has been saving lives in markets around the globe for the past four years, Niederauer said. In 2016, the system received its CE Mark, a certification that shows compliance with health, safety and environmental standards for products sold in the European market. Since then, the system has been available in Europe, Canada, Singapore, and the Middle East.

Clinical studies on the product performed in Europe were not accepted by the FDA in 2015. Almost identical studies were performed to gain the CE Mark four years ago, Niederauer said. 

According to the FDA’s website, the administration’s Center for Devices and Radiological Health is responsible for approving new medical devices. Devices on the De Novo pathway are rigorously reviewed so that similar products developed in the future can be cleared faster.

Following submission, the FDA has 150 review days, after which the agency must give a decision.

“In 2018, only 43 percent of all De Novo applicants were approved within the target 150 days, so we’ve exceeded the statistics,” Niederauer said. 

Bluegrass submitted their application in mid-August, Niederauer said. In 2017, the average review time was 243 days, she added, quoting the FDA’s latest report.

After a De Novo-approved product has gone into the market, the FDA keeps surveillance on the device to monitor its performance and requires annual reports.