Objective
With respect to the final goals of two devices for human clinical trials; these were realized in the approval for human clinical trials of a wound dressing, and an intravascular stent used in conjunction with Percutaneous Translumenal Coronary Angioplasty (PTCA). In the first case a surface modification was developed to enhance the binding of b-FGF to a surface to promote more rapid and complete wound healing. In the second case heparin was covalently coupled to a tantalum coronary stent to improve the blood compatibility of this device.
Key accomplishments in addition to the goals are:
1 Proprietary processes for attachment of heparin to all materials and devices.
2 State of the art analytical methods for analysis of heparin activity on surfaces.
3 Publications on advanced understanding of the mechanism of improvement of blood compatibility by a heparinized surface.
4 A large data base on performance of materials in blood as well as comparative performance of commercially available blood compatible surfaces.
5 Development of an infection resistant surface modification.
6 Four new device modifications in animal testing with anticipated approval for human clinicals before 1998.
The development of broad comprehensive knowledge in methods that are effective for whatever material or device is to be used permits rapid decisions as to the cost and feasibility. Equally important is the ability to characterize and guarantee specifications called out in manufacturing process control and quality assurance claims. In the biomedical business advanced understanding of biocompatibility and development of in vitro tests that are predictive of in vivo performance are critical for insuring product performance, and also critical in assisting in clinical protocols and follow up to assure safety and efficacy.
We conclude that we have achieved these capabilities in this project. Furthermore, they are presently in place in four development projects involving different device applications. The broad knowledge in material modification is in our opinion robust and horizontally applicable to new materials and devices coming to the market. The new technology being discussed in biomaterials is tissue engineering. Whether the new materials are biodegradable, biological, or hybrids; the know how developed in this project is applicable. While the efforts of this project are being turned over to development projects, the knowledge gained is being used in future planned research projects such as surface modification for hybrid synthetic organs and alternative new technologies for collagen and tissue fixation.
The main objective of this research project is to develop commercially feasible methods, applicable in manufacturing processes, for the modification of surfaces of biomaterials in order to improve the body's response to biomedical implants. The new methods have to be applicable for any geometric design of devices, and usable for the most common biomaterials. Success of the study will be realised through the completion of the following research tasks:
a. Evaluation of physical and chemical methods to activate or functionalise the most common biomaterials.
b. Characterization of the surfaces subjected to the above methods.
c. Developing chemistries for coupling bioactive molecules to functionalised/activated surfaces.
d. Apply the methods to different biomedical devices and biomaterials.
e. Complete in-vitro and in-vivo biocompatibility testing.
f. Manufacturing cost analysis of the modification process.
Successful completion of the research project should increase market share. Successful results will yield savings in EC public health conservatively estimated at 200 million ECU/year. Also effective biocompatible medical devices will add more life to years for patients.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- engineering and technology mechanical engineering manufacturing engineering
- medical and health sciences health sciences public health
- medical and health sciences medical biotechnology tissue engineering
- engineering and technology industrial biotechnology biomaterials
- medical and health sciences medical biotechnology implants
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
6229 Maastricht
Netherlands
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.