Hjarta Care’s EVAR XplantR for Aortic Endograft Explantation Receives FDA De Novo Authorization

April 29, 2026—Hjarta Care announced that the FDA has granted de novo authorization for the EVAR XplantR, which is a purpose-built, single-use device designed for the safe and efficient explantation of aortic endografts used in endovascular aortic repair (EVAR).

According to the company, the authorization establishes a new device classification for aortic endograft explantation tools. The FDA authorization was supported by multicenter simulated-use validation data demonstrating 100% atraumatic extraction and vessel preservation.

The company noted that traditionally, surgeons have relied on improvised ad-hoc tools—eg, modified syringes, orthopedic wire passers, heavy scissors, and hemostats—none of which are designed for the complex explantation procedure.

Rather than manual traction and improvised instruments, the XplantR device uses a smooth bull-nose leading edge and tapered cylinder to compress the stent graft while gently separating it from the aortic wall.

The company further explained that this atraumatic compression-based mechanism reduces drag force during withdrawal and constrains dangerous suprarenal fixation barbs within the device once released, thereby protecting both the patient’s vessel wall and the surgical team from sharps exposure. The device is available in four sizes (small, medium, large, and extra large), allowing surgeons to match the tool diameter to the patient’s aortic anatomy for minimal insertion and withdrawal trauma.

Hjarta Care stated that the XplantR was engineered around the SAFE principle: safe, atraumatic, fast, effective, achieved as follows:

• Safe—collapsing the stent-graft diameter within the protective bullet nose cylinder to prevent vessel wall injury
• Atraumatic—the bullnose and tapered lumen minimize arterial disruption while constraining barbs
• Fast—achieving an average explant time of < 90 seconds in the de novo submission study, compared to 20-40 minutes with ad-hoc techniques
• Effective—a curved design with open inner curve provides superior access and visibility in the operative field

Kellie R. Brown, MD, Professor of Vascular and Endovascular Surgery at the Medical College of Wisconsin in Milwaukee, Wisconsin, is coinventor of the XplantR.

“For too long, vascular surgeons have been forced to improvise during one of the most technically demanding and highest-risk procedures we perform,” commented Dr. Brown in the company’s press release. “The XplantR provides, for the first time, a standardized, atraumatic approach to endograft explantation—one that was designed around how these grafts actually integrate with the aortic wall and the unique dangers they present during removal.”