Five Years. One First-of-Its-Kind Device.

Some projects make noise early.

Others take years before anyone sees the work.

The EVAR XplantR™ belongs in the second group.

Hjarta Care recently received FDA De Novo authorization for the XplantR Explant Tool, a first-of-its-kind medical device to aid in explanting EVAR devices. It’s also described by Hjarta Care as the first purpose-built tool for open aortic endograft explantation.

That matters because the problem it was built to address was real.

For years, surgeons performing open aortic endograft explantation often had to rely on tools that were never designed for that procedure. Modified syringes. Heavy scissors. Orthopedic wire passers. Hemostats.

Those are workarounds.

The XplantR was built for the task.

It’s a single-use, disposable explant tool 3D printed using Formlabs BioMed White resin, a biocompatible material designed for surgical instruments. The device is available in two size configurations, KRB1923W and KRB2629W, to accommodate common suprarenal stent diameters.

Getting there took more than five years.

Five years of concept work. Development. Testing. Manufacturing refinement. Process control. Regulatory navigation. Documentation. More documentation. Then probably another stack of documentation just to keep everyone humble.

STS Technical Design is proud to have supported Hjarta Care from concept and development through production.

And because this work sits inside the medical device space, “support” does not mean simply making something and moving on.

It means discipline.

It means repeatability.

It means knowing that materials, manufacturing methods, design decisions, and documentation all have to stand up to a level of scrutiny most products never face.

The FDA’s De Novo pathway exists for novel medical devices where there is no legally marketed predicate device. In plain English, the XplantR was not following a well-worn path. It was helping establish a new one.

That’s hard work.

It should be.

According to project stakeholders, this is the first product to complete the FDA De Novo process using Formlabs resins and the first to utilize the BioMed White master material file maintained with the FDA. That detail is important because it points to something bigger than one device. It shows how additive manufacturing can continue moving into highly regulated medical environments when the engineering, material controls, and quality systems are built the right way.

Still, the story here isn’t just about a material.

It’s about persistence.

Hjarta Care had a clinical problem to solve. The XplantR was developed to meet that need with a purpose-built approach. STS Technical Design helped support the engineering and manufacturing path required to turn that idea into a production-ready medical device.

That’s the part people don’t usually see.

The years behind the product.

The quiet decisions.

The revisions.

The validation work.

The patience required to do difficult things correctly.

Hjarta Care was STS Technical Design’s first client. Seeing this project reach FDA De Novo authorization is more than a milestone. It’s a reminder of why the work matters.

Good engineering does not always announce itself loudly.

Sometimes it shows up after five years of doing the hard thing the right way.