A team of clinician-researchers from the National University Health System (NUHS) in Singapore has created a naturally-designed customisable mitral valve bioprosthesis, SingValve.
This heart implant imitates the human mitral valve’s look, structure and physical properties.
Patients with severe mitral valve disease, such as rheumatic heart diseases and advanced degenerative disease require mitral valve replacement when it becomes leaky, obstructed and non-repairable.
At present, two major types of artificial mitral valves, mechanical valves and bioprosthetic/tissue valves, are available in the market. These valves are said to be unnatural, stiff and circular, as well as not being customisable, which can cause obstruction of left heart chamber movement.
Made using the patient’s or animal tissue, SingValve comes with a ring that is flexible and facilitates heart contraction and dilation, as it does with a native mitral valve.
This could offer reduced shear stress in the left heart chamber and enhance heart recovery after the procedure.
The SingValve can be stitched onto the papillary muscles of the heart chamber to lower foreign body reaction and infection risks.
Furthermore, the implant can be tailored according to patients’ needs based on their pre-operative scans.
In May, the National Research Foundation Singapore (NRF) Central Gap Fund awarded a $3.6m (S$4.9m) grant to progress the development of SingValve.
This fund will support validating the implant in vitro and in pre-clinical trials, comparative studies with currently available valves and product verification.
NUHS plans to carry out the first-in-human trials of the implant, with 15 human implantations in two to three countries by 2023.
National University Heart Centre, Singapore, associate professor Theodoros Kofidis said: “SingValve was developed as a heart valve implant that is made for the individual patient.
“It belongs to the highest class of implants in regulatory terms, and constitutes a Class III implant, which is the first of its kind globally, made in Singapore.”
A SingValve manufacturing facility and logistic supply hub will be set up in Singapore. The facility could create jobs for the country’s MedTech industry and increase research and development as well as medical tourism.