Bluegrass Vascular Technologies is making catheter placement procedures for dialysis and chemotherapy easier and safer using inside-out technology, explains CEO and President Gabi Niederauer.
Bluegrass Vascular Technologies has figured out a way to make a catheter sheath go inside the body and back out for easy catheter placement in standard access procedures.
The San Antonio, Texas–based company’s Surfacer Inside-Out access system facilitates catheter insertion into the central venous system. The company designed it for use in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
One of the challenges of having a catheter in the body for weeks or months for dialysis or chemotherapy is the risk of blood clots. Thrombosis forms 50% of the time when health providers insert catheters into people for an extended period of time. When thrombosis occurs in a long-term catheter, it can turn into a chronic occlusion — which happens in an estimated 16% of long-term catheters, according to Gabi Niederauer, president and CEO of Bluegrass Vascular Technologies.
Catheter placement can also become difficult if the right internal jugular becomes chronically occluded. When this happens, a doctor may try to gain access to the central venous systems through the outside of the body using a sharp needle. However, this can further complicate the procedure and create a dangerous situation as it often requires blind placement of the needle near the heart and lungs.
“Some doctors try to go in the femoral vein and push a sharp guide wire through the occlusion and snare it on the other side. But what’s most commonly done is if they don’t get access on this side, they just go to the other side,” Niederauer told Medical Design & Outsourcing. “What then happens is for patients who are dependent on catheters like a dialysis patient, they just burn up all of that central vasculature. They essentially cause the same thing to happen on the left side.”
Simplifying catheter placement for safer procedures
Interventional cardiologist Dr. John Gurley developed Bluegrass Vascular’s Surfacer technology to assist in catheter placement. It goes in through the femoral vein and essentially straight through the body to just above the clavicle, where the distance from occlusion to the skin surface is just a few centimeters. There, the doctor can push a sharp wire out to safely pull a catheter in.
The operator navigates the Surfacer from the femoral vein and exits the venous vasculature. A sheath advances over a guidewire to the venous obstruction and provides a conduit for all instruments used during the procedure.
A target goes on the exit area of the body, and the device then pushes through to the obstruction. The system operator adjusts Fluoro, an imaging agent, until the tip of the device is visible within the exit target. Next, the person operating the Surfacer rotates its handle until the target window appears and advances the needle out of the tip.The occlusion acts as a stabilizer for the needle wire to pierce the skin at the exit point, and the operator inserts a sheath from the outside in. Finally, there is the removal of the Surfacer removal. Catheter placement takes place through a standard access procedure.
The entire process takes about 20 minutes.
“Essentially, it helps provide vascular access in the right internal jugular for patients whose veins have closed up chronically or permanently. Placement of central venous catheters are done for dialysis access, for nutrition, for chemo, for a number of different reasons. Approximately 6 million central venous catheters are placed each year and about 20% of those are long-term catheters,” Niederauer said.
Bluegrass Vascular Technologies’ Surfacer vascular access device is already in the commercial stage. Health providers have used it in nearly 700 cases. The Surfacer has 13 peer-reviewed publications. It has a CE mark approved, and the FDA granted it a de novo clearance in February 2020. The Centers for Medicare and Medicaid Services assigned the device a New Technology Ambulatory Payment Classification (APC) in September 2021.
Innovative technology creates bumps in the road
One of the main challenges when developing medical devices is the regulatory pathway, and the Surfacer was no exception.
“This is such a novel concept,” Niederauer said. “There’s no other device that enters the body and then comes out of the body, so that was a challenge for the FDA since no other cleared devices operate in that manner.”
The Surfacer went through different divisions of the FDA before it got de novo clearance and the divisions had different expectations on the data set used, she said.
With de novo classifications, the FDA is reviewing devices that are new to the market and do not have substantially equivalent predicates already on the market. The process is typically more rigorous, Niederauer explained.
“Our de novo review by FDA was actually very predictable. We were able to get it approved within their 150 days, where only around 42% of de novo [applications] get reviewed and cleared that quickly,” she said. “So that was a good accomplishment on our end, but then with the pandemic hitting shortly after our FDA approval, we couldn’t really get into hospitals to train physicians and proctor cases. So that slowed down our launch.”
Because the Surfacer System is so unique, another challenge Bluegrass Vascular had to face was obtaining a reimbursement code from CMS. The company applied for a new technology payment classification which would cover the device and the associated procedure the device is used for; however, CMS felt the procedure was already described by the code utilized for the placement of a tunneled catheter.
“It was not just placing a tunnel catheter though, so we had to go back and forth with CMS and that took 19 months, which is a lot longer than 90 days,” Niederauer said.
Focused, direct sales team to drive product adoption
Bluegrass Vascular Technologies has used distributors for its Surfacer since it’s been on the commercial market. But the company is establishing its own sales force and will begin selling the device directly in the U.S. starting Jan. 1, 2023.
The Surfacer technology is new to the medical device industry, so Bluegrass Vascular is still establishing the importance of the device with physicians — and that’s why it is recruiting sales managers with expertise in the vascular space, Niederauer said.
“We believe the type of missionary selling needed to promote a practice-changing device is best done by our own team. The individuals we have hired are passionate about the Surfacer System and the opportunity to promote our life-saving technology. Building out our own direct sales is what’s in store for us in 2023, and I’m really excited about the team we have put together to drive our business forward.”