expertise in collagen

Rematrix Breast

ADM for breast reconstruction

Thin ADM (0.6 mm) for breast reconstruction

Rematrix Breast is a collagen matrix derived from pig skin. The ADM is preserved by lyophilisation and is free of preservatives. It is cell-free and non-pyrogenic. Acellular dermal matrix (ADM) is used as an implant to regenerate and strengthen soft tissue. Through cellular and vascular immigration into the structure of the implant, new regenerated soft tissue grows and the implant material is fully incorporated. Already two months after the procedure, histological examinations of tissue samples have shown that the ADM is fully integrated into the recipient tissue. At the same time, the remodelling of the ADM into revascularised recipient tissue occurs in parallel with the complete integration of the xenogenic collagen.

Properties

  • strong and biocompatible implant
  • only 0.6 mm thick
  • grows into the recipient tissue through cellular and microvascular infiltration
  • simple handling, well suturable and adaptable
  • the collagen matrix is completely transformed into the body’s own collagen tissue within a few months.
  • Flexible in the choice of method (subpectoral or prepectoral application) due to the 30*21 cm dimension (REF RM30-06).

Applications

Rematrix Breast is intended for breast reconstruction after mastectomy in a single-stage procedure. Rematrix Breast can be used as a rectangular membrane for the subpectoral implantation technique or after prior cutting by the surgeon for the prepectoral implantation technique. In the subpectoral implantation technique, the ADM acts as a kind of extension of the pectoralis major muscle. Prepectoral breast reconstruction (PPBR) after tumour-induced mastectomy is becoming increasingly common in clinical practice. The most significant advantage is that the pectoral muscle is spared. Compared to the subpectoral technique, this is associated with a significant reduction in pain and time to full recovery and weight-bearing capacity of the arm and shoulder. Another advantage of the prepectoral placement is that possible tension transfers from the pectoral muscle to the implant are avoided. These could lead to unnatural changes in breast shape known as “dancing breast” or “animation deformity”. In the prepectoral technique, the implant is positioned on the pectoralis major by fixing the collagen membrane with interrupted sutures. The function of the muscle is thus preserved.

Practical application description

Rematrix Breast can be adjusted to the desired size and shape with scissors in a dry or rehydrated state while maintaining sterility. If necessary, two products can be sewn together. The use of appropriate templates may be useful in determining the area required. Rematrix Breast Membrane is supplied dry and must be rehydrated before implantation by placing it in a sterile dish at room temperature for at least 5 minutes after opening the pack and covering it completely with sterile saline, Ringer’s solution or Ringer’s lactate solution. Rematrix Breast will become glazed when rehydration is complete. When inserting the Rematrix Breast membrane, maximise contact with healthy, well-vascularised tissue to promote cell ingrowth and new tissue formation. Suture the inserted membrane to the detached pectoral muscle and chest wall (for subpectoral breast reconstruction) or the fascia of the pectoral muscle (for prepectoral breast reconstruction) around the inserted breast implant. Complete the standard surgical protocol, making sure there are no gaps between the membrane and the inserted breast implant and the sutured skin flaps.

Physicians must be familiar with the surgical procedures and techniques for biological surgical matrices and specifically for ADM-assisted implant-based breast reconstruction before using Rematrix Breast. When selecting patients, the following conditions are associated with an increased risk of complications and require individual consideration of the benefit/risk ratio by the surgeon. morbid obesity with an increased BMI > 40 kg/m²; inadequately controlled diabetes mellitus; active smoker; chronic immunosuppression; damage from previous radiotherapy.

  • Medical device class III
  • Source of collagen: porcin
  • Free of preservatives, no chemical cross-linking
  • Thickness: 0.6 mm
  • Easy handling
  • Easy storage at ≤ 24°C
  • Has excellent biocompatibility
  • No risk of human virus transmission
  • Manufactured in Germany

Intended use

Rematrix Breast is an acellular dermal matrix for implant-based breast reconstruction and is intended for human implantation. Rematrix Breast is indicated for:

  • the subpectoral “one-step” breast reconstruction, especially after mastectomy, and is used to cover the inferior pole of the implant.
  • the subcutaneous (prepectoral) “one-step” breast reconstruction and is used to partially or completely cover the implant

Article number (REF) / Size / UDI-DI

  • RM15-06/ 15*8 cm/ 426023090507
  • RM18-06/ 18*10 cm/ 426023090508
  • RM22-06/ 22*12 cm/ 426023090509
  • RM30-06/30*21 cm/ 426023090510

One product per unit.


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