About 300,000 patients each year receive a heart valve replacement that is either a mechanical device or produced from animal tissue. Although these valves generally improve survival and quality of life, they do not consist of living tissue and therefore cannot grow with the patient or repair themselves in case of damage. Especially for younger patients, this results in a high probability of repeated valve replacements, with associated risks to health and even life.

The supramolecular polymer material is formed into the shape of a heart valve that is sutured to a stent.

The researchers in the ImaValve (Intelligent materials for in-situ heart Valve tissue engineering) project want to realize the dream of a creating a living heart valve that is grown inside the patient’s body at the site of destination and that consists of the patient’s own tissue. As such, the valve should be able to repair itself and grow with the patient. The ImaValve is a device that consists of a slowly degrading elastomeric polymer, processed into a valve shape via a process called electrospinning. The valve can be placed in the body in a minimally invasive fashion using a stent and a delivery device.

According to the researchers, the valve uses the body’s wound repair processes. The valve is created with a supramolecular polymer that has the right properties to communicate with the processes in the human body. This polymer is produced into a fibrous structure using electrospinning. The material is formed into the shape of a heart valve that is sutured to a stent, which is used to deliver the valve at the right site.

The system is based on a stented heart valve, which can be introduced via the groin or via a very small incision in the body. This enables the heart valves to be replaced in a very fast and safe manner in many patients. The researchers say that under live imaging such as fluoroscopy, or echo, they can deliver the heart valves to patients in a very controlled manner.

“The most fascinating thing is that we create a polymeric-based valve that is so smart to attract the right cells in the right moment within the body to transform into a living heart valve, says Prof. Dr. Max Emmett, cardiac surgeon at the University of Zurich.

ImaValve is a collaborative project funded by the European Commission under the Seventh European Framework Program. Within this consortium, leading academic and industrial partners in the field of biomaterials science and tissue engineering from The Netherlands (Leading House), Switzerland, and Germany are brought together. The project is coordinated by Carlijn Bouten, head of the Department for Soft Tissue Biomechanics & Tissue Engineering at Eindhoven University of Technology.

With a highly multidisciplinary approach, merging biomaterials research, in vitro and in silico modeling, and technological developments to preclinical studies, the ImaValve consortium aims at framing innovative solutions for the challenging research field of in situ cardiovascular tissue engineering.

The goal of the project is the development of an off-the-shelf available synthetic heart valve that gradually transforms into a living heart valve at the site of implantation and that lasts a lifetime. The researchers say that the ImaValve combines the unique expertise and experience necessary to achieve the ambitions of the project in a time frame of about four years.

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