Heart Valve

The allograft heart valve product is derived from a cadaveric donated heart 48h after cardiac arrest. Prior to retrieving the whole heart from a mortuary or dedicated donation suite, the donor screening in case of age limitation (1 to 55 years old), medical history, and physical examination is performed. Then, the valve is carefully dissected from the heart in a licensed pharmaceutical grade cleanroom (GMP classification B) to remove excess myocardium, fat, and connective tissue. At this stage, the valve is treated with an antibiotic cocktail to reduce the bioburden. It should also be noted that in order to assure the product safety, several quality control tests such as microbiologic & serologic assays are carried out; each sample is tested for aerobic and anaerobic bacteria, fungi & HIV antibodies type 1, 2 (anti- HIV1&2), antibody to human T-lymphotropic virus type 1,2 (HTLV Ab1,2), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCVAb), Hepatitis B surface Antigen (HBsAg), and RPR for syphilis.

Benefits

Biocompatible with surrounding blood cells and able to restore the patient’s normal blood flow
The avoidance of lifelong warfarin therapy is required for preventing the emergence of blood clots
Negligible risk of disease transmission/infection regarding the performed restrict quality assurance
Low rejection or mortality rate in long-term due to its optimum capability of mimicking the native tissue function compared to its alternatives such as mechanical heart valves
Availability in various sizes to best fit the patient’s anatomy
Effective orifice area closely approximates the native valve
Cost-Effectiveness in comparison to its efficacy

Clinical Application

Valves are used in cardiovascular surgery for the aim of repairing congenital heart diseases and aortic valvular insufficiency. Moreover, it is intended for the replacement or reconstruction of diseased, damaged, malformed, and malfunctioning prosthetic heart valves.

Storage Condition

The product is packaged in nylon film in two layers and finally in an aluminum envelope. The package should be inspected before use to ensure that it is not damaged. This product is stored in liquid nitrogen vapor phase conditions (-150° to -187° Celsius) for up to 5 years. Also, it could be stored at -80° Celsius for up to 6 months.

Product Code	Product Name	Therapeutic Area
5060020	Cryopreserved Heart valve Aortic L=40-65 D=9-31 mm	Cardiovascular
5060021	Cryopreserved Heart valve Pulmonary L=40-65 D=9-31 mm	Cardiovascular