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

BONE TUMOR RESECTION

 

A patient-specific resection guide is a custom-made instrument that helps the surgeon transfer a preoperative planning into the operating room to accurately resect a bone tumor. These guides drastically reduce the risk of local recurrence from 36% to 0%, while sparing nerves, joints and any other important bony structure. Utilizing this time-efficient solution improves the patient’s quality of life and recovery thanks to its flat surface.

  • Advanced planning

  • Resection guides

  • All kinds of reconstruction

  • Safe margins & accurate

  • Easy to use

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PATIENT SPECIFIC IMPLANT TECHNOLOGY

 

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 leadtime. 

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

 

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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3D MEDICAL 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 osteosyntesis 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.