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FDA 510(k) clearance for its 3D-Cut patient-specific instrument

BONE TUMOR RESECTION ¹

 

A patient-specific resection guide is a custom-made instrument that helps the surgeon convert a preoperative planning into the operating room to accurately and safely resect a bone tumor.

3D-Side guides are more accurate for bone tumor resection than freehand or navigation system-assisted surgeries.

These guides reduce inaccuracy by 80%, R1 resections by 44% and blood loss by 33%, while allowing a 45-minute reduction in OR time on average².

Additionally, a better control over the safe margin means more conservative treatment, leading to preservation of critical soft and hard tissues such as nerves, muscle insertions and even joints.

 

  • Advanced planning

  • All kinds of reconstruction³

  • Safe margins & accurate

  • Time efficient

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PATIENT-SPECIFIC IMPLANT TECHNOLOGY ⁴ 

 

The device is a patient specific mold that can create a patient specific cranial implant from polymethylmethacrylate (PMMA, bone cement) during surgery.

Latest technologies are used for the design (AI-based segmentation & unique platform for the surgeon) and production (high accuracy 3D printer) of this device allowing short lead time. 

Based on the CT-scan of the patient, the mold is manufactured and delivered to the hospital for final sterilization. By setting PMMA in the mold, an implant is created in the OR. In just a few minutes the implant is ready to be fixated in the patient.

  • Perfect fit 

  • One step resection and reconstruction

  • Cost effectiveness

  • Excellent long term results thanks to the gentamycin

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CORRECTIVE OSTEOTOMY ¹

 

When bones are misaligned, a corrective osteotomy surgery can be required. The high technical requirements (corrections of different angles in different planes), the complex bone geometry, the limited visibility and the restricted workspace can result in a difficult surgery.

A patient specific cutting guide is a custom-made instrument that helps the surgeon cut a bone. Coupled with a preoperative planning, the guide(s) will transfer this planning into the operating room, resulting in an accurate and time-efficient osteotomy correction. A fixator guide can be provided as well to guarantee the correct final position and alignment of the resected bones.

Both opening and closing wedge osteotomies are possible with this technique, as well as synostosis.

  • Avanced planning

  • Cutting guides

  • Accurate

  • Time-efficient

  • Easy to use

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MEDICAL 3D PRINTING 

 

An anatomical model illustrates extremely precisely the anatomy of a specific patient, with the aim of planning and discussing the surgery much more easily.

First, the reconstruction of the patient's anatomy is performed based on the patient's medical images. Then, the models are produced by means of high-tech 3D printing to provide the surgeon with sterilizable and biocompatible models of the patient. Those models can therefore be used inside the operating room, assisting the entire surgical team.

To what extent can the surgical team use a patient-specific anatomical model ? To analyze a situation, simulate & plan the surgery, select osteosynthesis material, support a staff meeting, communicate with the patient ...

  • Biocompatible

  • Sterilizable

  • Accuracy

  • Flexibility

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Each product is designed for one specific patient and it all starts with their medical images. Check out how surgeons can send patients' images and interact with our team to make their journey easy and successful. 

¹ In the USA, limited to anatomies and age specified in the 510(k) certification.
² 3D-Side Data on file.
³ Reconstruction planning and reconstruction guides not available in the USA.

⁴ Not available in the USA.