Hjarta Care secures FDA authorization for vascular surgery device

With a growing number of patients requiring complex follow-up procedures after minimally invasive aneurysm repair, a Milwaukee-based medical device company is introducing a new tool designed to make one of vascular surgery’s most challenging operations faster and safer.

Hjarta Care recently received U.S. Food and Drug Administration De Novo authorization for its EVAR XplantR™, a single-use device designed specifically to remove aortic endografts, which are implanted devices used to treat abdominal aortic aneurysms.

The authorization establishes a new device classification, positioning the XplantR as the first purpose-built tool for a procedure that surgeons have historically performed using improvised techniques.

Addressing a gap in vascular surgery

Endovascular aortic repair (EVAR) has become the dominant treatment for abdominal aortic aneurysms, accounting for more than 75% of elective repairs in the United States.

However, a subset of those procedures fail over time due to complications such as endoleaks, infection or device migration. The only solution to the failure is an open surgical removal of the implanted graft. Approximately 2,000 of these high-risk procedures are performed annually in the U.S., with complication rates as high as 37% and mortality rates reaching 43% in emergent cases.

Despite the complexity of the operation, surgeons have typically relied on modified syringes, wire cutters and other ad hoc tools not designed for the procedure. That gap is what led founder Brian Thorson to develop the XplantR.

From industry experience to invention

Thorson spent more than 15 years working in the aortic division at Medtronic, where he sold minimally invasive devices used to treat abdominal aortic aneurysms.

During that time, he observed a recurring challenge: while minimally invasive repairs were effective in most cases, a small percentage required surgeons to later remove the implanted device through an open procedure.

“That operation is technically demanding and time-sensitive,” Thorson said during an interview. “There was no purpose-built tool to do it.”

Working with Milwaukee-based vascular surgeon Dr. Kellie Brown, Thorson began developing a device designed to safely compress and remove the graft without damaging the surrounding vessel.

The result was a patented design that uses a tapered, cylindrical structure to collapse the graft and reduce resistance during removal, while containing sharp fixation elements that can pose risks to both patients and surgical teams.

A long path through the FDA

Although the device was initially expected to qualify as a lower-risk medical tool, regulators determined there was no existing predicate, requiring it to follow the more rigorous De Novo pathway. That process involved extensive testing, including simulated-use validation studies rather than traditional clinical trials, due to the relatively small number of procedures performed annually.

The company submitted its application in 2025 and received authorization in April 2026, placing it among a small number of devices each year to successfully navigate the De Novo process. The XplantR now serves as the predicate device for future products in this category.

Manufacturing and market entry

With authorization secured, the company is now preparing for commercial rollout.

The device is manufactured in Brookfield by STS Technical Group, using 3D printing, which allows the company to produce smaller volumes while maintaining flexibility for future design iterations.

The initial market is relatively concentrated. Of roughly 3,500 acute care hospitals in the U.S., about 1,500 have vascular surgeons on staff, and only a subset regularly performs the type of procedure the device is designed for.

While the total addressable market is limited compared to other medical device categories, the clinical impact could be significant.

The device is designed to reduce the time required to remove an implanted graft Typically, removal using traditional methods takes 20 to 40 minutes, compared with an average of less than 90 seconds in validation testing. This reduction in procedure time lowers the risk of complications tied to prolonged interruption of blood flow.

For hospitals, that could translate into fewer complications and lower downstream costs. For patients, it may mean improved outcomes in a high-risk procedure.

Thorson said the focus remains on solving a problem surgeons have faced for years.

“We’re not trying to sell millions of these,” he said. “We’re trying to make a difficult operation safer.”