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XplantR IFU

XplantR Instructions For Use

Hjarta Care was granted FDA De Novo authorization for the XplantR Explant Tool XplantR is a first-of-its-kind medical device to aid in explanting EVAR devices.

Important: consult CT, ultrasound or MRI to measure inner diameter of aorta - key step in selecting appropriate size XplantR

Explant overview

Stent graft implant with cross clamp applied

XplantR is loaded on to the distal aspect of the stent graft using a curved Kelly clamp or similar instrument in preparation for explant

Stabilize stent graft with the curved kelly and provide gentle counter traction. Slowly advance the XplantR proximal, gently compressing the stent graft using the smooth bullnose lead edge of the XplantR. DO NOT PULL THE STENT GRAFT

Once the suprarenal fixation has been captured and compressed, remove the XplantR and stent graft in unison to avoid intimal injury

Explant Video

Normal explant

NOTE: Tissue ingrowth may prevent advancement of the XplantR, avoid excessive force risking damage to the vessel wall

Explant below simulates severe tissue in-growth restricting SAFE advancement of the XplantR.

When unusual resistance is encountered, stop and reassess.

If possible, free tissue in-growth before re-attempting explant.

Improving the surgical explant of endovascular stent grafts

  • United States Patent No.: US11,351,047 B2

  • Modification risks:

    cutting syringe: injury to surgeon or staff

    damaging aortic intima with jagged edge:

    dislodge plaque or tear intima

    catch on stent rings

  • Simplicity, Reduced Trauma, Speed and Elegance should improve morbidity