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Braxon ADM

Braxon ADM


Braxon ADM



Download hier de brochure van Braxon.

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  • Productinformatie

Braxon® is designed and patented by DECOmed s.r.l. , for international distributors please use: info@decomed.it.

Braxon® is a synthesis between the most advanced biomaterial and the most conservative anatomical impact for the patient.

the simpler the better
Braxon® is the result of the experience which has developed in the field of tissue bio-engineering joined with that of clinical practice aiming to create a more conservative surgical procedure.

The study of the biomaterial’s regenerative capacity applied together with the constantly ambitious challenges in the field of reconstructive surgery has led to the emergence today of an innovative surgical technique which signals a further enhancement in the field of onestep breast reconstruction.


The one-step breast reconstruction, when indicated, has highlighted important benefits for the patient, who recovers her physical integrity in a single operation, together with significant cost savings for the health economy.

Innovations in the field of biomaterial have contributed in a major way to enabling this new operation to substantially improve the cosmetic outcomes of immediate breast reconstruction.

Muscle sparing. Why?
The disinsertion of Pectorails results in a deficit of muscle function of arm flexion, internal rotation and adduction. Over time the interference in the synergy of the various muscle groups may result in weakness of humeral-scapular articulation with repercussions in movement, pain and also an impaired cosmetic result.
The creation of a sub-muscular pocket for the normal procedures, one-step or two-stage breast reconstruction is
longer and more complicated and requires postoperative physiotherapy.

The disinsertion of the muscle causes bleeding, postoperative pain and seroma.

   

Above muscular pocket. How?
Recent publications have shown a lower ratio of capsular contractions if the breast prosthesis is wrapped in a biological matrix.
Braxon® is a pre-shaped porcine dermis which allows the tailoring of an ADM pocket around the mammary prosthesis and its fixing above the pectoralis muscle, which is kept intact. Covered by 3 patents, the Braxon® shape perfectly matches the contours of a silicone prosthesis. Having chosen the size and shape of the implant, the customised preparation of the pre-shaped gra! to fit around the silicone implant is carried out on a sterile work surface, while the assistant surgeon checks for haemostasis and places the drain in preparation for the insertion of the implant, neatly wrapped in the Braxon ® graft, thereby optimizing the operation time.

Braxon®. When?
In one-step reconstruction a!er nipple or skin sparing mastectomy. When there is a good vascularised sub-cutaneous layer.
Previous radiotherapy or co-existing medical conditions such as diabetes or connective tissue diseases are contra-indications. The use of monopolar diathermy in the mastectomy skin flap dissection should be reduced to a minimum to prevent skin flap necrosis.


Technical characteristics
The Braxon® implant is made of porcine dermal extracellular matrix(*) with a thickness of 0.6 mm.

The exclusive production process has been developed with the aim of generating a completely natural product (not crossed linked) without the presence of any chemical substance which can amplify the inflammatory response and slow the pathway of tissue regeneration.
The native proteic structure provides the benefit of immediate bio-availability for incorporation into the host tissue with lower inflammatory responses such as seroma or the red-skin flare phenomenon seen following the implantation of other biomaterials used in
breast reconstruction.

Natural, artificial and synthetic matrices.
The natural Braxon® matrix is made of native proteic polymers derived from acellularized tissue of porcine dermis (collagen). The organism recognises it as its own, and transforms it into self tissue through the natural regenerative process (remodelling).

Artificial meshes derive from natural polymers, but theyare chemically modified for reinforcement (e.g.. Crosslinked
meshes). They are tolerated by the organism but do not stimulate any regenerative process.

Synthetic meshes, made of polymers obtained by chemical synthesis (Polypropylene with metal coatings for example), are chemically and physically tolerated by the organism but they do not stimulate a regenerative process.

Nowadays the concept of biocompatibility isn’t enough to define the effectiveness of a biomaterial. Its
performance must surpass passive tolerance. It must be active, not solely inert, with the aim of powering the
biological process of guided tissue regeneration.

In order to allow Braxon® to be incorporated into the tissues without an amplified inflammatory response, the production process entails the sublimation (freeze drying ) in the final phases of the newly created acellular gra!, which allows the complete removal of the liquid
chemicals used in its preparation through exact use of pressure and temperature. This process makes the product dry, optimal for correct conservation at room temperature, and only requires a simple rehydration before use, without the need for repeat washings to
attempt the removal of damaging chemicals which other products require.

Its patented shape allows a perfect fit around the silicone prosthesis which creates a smooth surface with no gra! over-lap a!er simple suturing to the muscle surface. It fits neatly under the skin in a perfect position, checked by the elevation of the patient prior
to closing the skin wound.

Implantation technique
Braxon® must be sutured to the pectoralis major with single stitches to ensure primary stability of the matrix which requires intimate contact with vascularized tissue.

Postoperative management
Early and prolonged use of a conforming bra for 3 or 4 weeks as well as a compressive dressing and reduced mobility of the arm will significantly decrease the seroma formation.

(*)Porcine extracellular matrix:
A complex network of extracellular macromolecules that, in addition to performing a cementing function between cells and tissues, provides an organized structure in which the cells can migrate and interact with each other.

The management of economic resources requires a ‘careful assessment of costs and benefits’.
In pharmacoeconomics it is provided through accurate estimation of certain parameters

 


Surgical Steps






Questions & Answers

Is Braxon® supplied already shaped?
Yes – It is supplied in a pre-shaped size to wrap around di"erent sizes of mammary prosthesis.

How is the Braxon® customized to fit precisely around the chosen implant?
The surgeon adjusts the pre-shaped Braxon®  on a sterile work surface as shown in the brochure.

Can I use different implant sizes and shapes?
Yes the pre-shaped Braxon®  is adjusted to fit around any shape or sized implant.

What sutures should I use?
Interrupted 3 0 absorbable so! braided sutures.

How to suture?
Once the tailored customized ADM has been sutured in place around the chosen implant, the superior and upper medial and lateral edges are sutured onto the pectoralis muscle having elevated the patients upper body to check symmetry with the opposite breast.

How many drains and for how long?
The inflammatory response to the new Braxon® chemical-free ADM is much less, and as a result our experience has shown the drains can be safely removed within a few days, and certainly less than the 2 weeks necessary when alternative products are used.

What about capsular contraction and cosmesis?
To date, with follow-up at 1 year there has been no clinical evidence of capsular contraction around the sub-cutaneous placement of the Braxon®-wrapped implant.

Do I need to consider using a round implant to avoid the risk of rotation o"en seen in sub-muscular implant reconstruction?
No, since the Braxon®-wrapped implant is on top rather than underneath the muscle, it is not subjected to the rotational forces of muscular contraction, and also looks more natural when a shaped implant is employed. Nevertheless Braxon® can perfectly “dress” also a round implant, with same good cosmetic results.  

 
 

Braxon® bilateral implantation with anatomical implants - 2 year
postoperative photographs

Afmeting
Braxon is leverbaar in 1 maat, geschikt voor implanaten tot een grootte van ongeveer 450cc.
Artikelnummer: BRX06S