Technical & Innovation News Biological & Solutions Cardiovascular Electromechanical Endovascular Oncology Biocompatibility and calcification of Braile Biomédica's bovine pericardium heart valve Braile Biomédica's bovine pericardium heart valve is a bioprosthesis suitable for mitral, aortic, tricuspid, or pulmonary valve replacement, made ? f bovine o pericardium (BP) from tracked cattle, processed with Glutaraldehyde (GA) and oxidative treatment developed by Braile Biomédica, aiming at reduction of polymeric GA links and free aldehyde groups, which demonstrably contribute to reduce the (1) post-implant calcification level of valvular bioprostheses . The manufacture of Braile Biomédica's bovine pericardium heart valve complies with quality standards required nationally and internationally. The bioprostheses is characterized by mechanical and elastic properties required for this type of implant, high level of bio and hemocompatibility, low irritability, and especially low calcification rates demonstrated at in vivo tests in rat and sheep subcutaneous. These properties are responsible for low rates of structural deterioration observed at Braile's BP heart valve post-implant. Manufacture Braile Biomédica's bovine pericardium heart valve cuspids (Figure 1) are assembled on a p o lya c e t a l s u p p o r t c o a te d w i t h b ov i n e pericardium, and, a stainless steel ring inserted externally at its base, enhancing the it's consistency and allowing identifying the implant position through a simple radiologic examination. The valves are manufactured in sizes 19, 21, 23, 25, 27, 29, 31, 33 and 35 mm, packed in hermetic plastic container with a solution of 4% formaldehyde and the sterility is guaranteed by validated procedures. Figure 1. Braile Biomédica's bovine pericardium heart valve made from bovine pericardium processed with glutaraldehyde and oxidative treatment.

Subcutaneous Calcification The effective reduction of post-implant calcification in bioprosthesis processed with Glutaraldehyde (GA) is currently performed by chemical procedures for elimination / reduction in one of two most important factors involved in ectopic calcification of bioprostheses, which leads to structural deterioration over time: a. Removal of structural phospholipids from the cell membrane; b. Elimination or reduction of free aldehyde groups existing in processed tissue resulting from the partial reaction of the tissue with glutaraldehyde and crosslinking bonds formed by pre-existing...

The determined calcification level in explants of 60 days for Bovine Pericardium processed with glutaraldehyde associated with an oxidative treatment was 5.7 ± 1.3 ìg Ca/dry tissue. This value is comparable to those used in the manufacture of Bovine Pericardium valvular bioprosthesis also processed with glutaraldehyde and treated with other methods to reduce calcification and that admittedly, have demonstrated its effectiveness in reducing structural deterioration of valvular bioprosthesis after implantation, especially as result of dystrophic calcification (Figure 3). Ethanol: Polysorbate Oxidative...

Braile´s Heart Valve GA Ethanol: Polysorbate Braile´s Patch Oxidative Process Ethanol: Octanediol Treatment Figure 4: Calcification level of Braile Biomédica's bovine pericardium heart valve and patch compared to bovine pericardium heart valves processed with glutaraldehyde + anti-calcification treatments recognized as effective in reducing bioprosthesis structural deterioration. Aiming at reducing further more the effects of post-implantation calcification, Braile Biomédica is developing new technologies associated to the current process, such as a treatment of processed bovine pericardium with...