A request for applications (RFA) is proposed, entitled "Use of 3D Printing for Creation of Implantable Devices." using the R21/R33 mechanism. The proposed RFA will use the NIH Exploratory/Developmental Research (R21) and Exploratory/Developmental Grants Phase II (R33) grant award mechanisms.
A particularly difficult issue for the care of infants and young children who need implanted devices is that the children grow, but the devices do not. Thus, children receiving device may need multiple surgeries for revision as they grow. 3D printing, a form of additive manufacturing, may potentially provide a solution to meet this need. 3D printing builds up part layer-by-layer from a digital model from metals, plastics, or even ceramics and has the potential to produce complex biomedical devices according to computer design using patient-specific anatomical data. This process allows for complex devices matched to a patient's anatomy. Most importantly, because 3D printing does not require specialized cutting tools or molds, design changes can be made very rapidly and applied to only a small number of units. Recently published RFA-HD-15-023 and RFA-HD-15-024 invited applications that will lead to development of minimally invasive/non-implantable flexible medical devices. The purpose of this RFA will be to invite submission of R21/R33 applications that will lead to the development of implantable devices that will adapt to the needs of growing children.
The work to be supported by this FOA requires four components:
- Identification of a specific clinical problem in children that will be solved by device implantation where the device needs to adapt to the child's growth.
- Development of 3-D printed biodegradable scaffolds appropriate to the clinical problem.
- Testing of the scaffold in long-term animal models.
- Under certain circumstances, patients may have received such devices under Compassionate Use Exemptions. This FOA would also support long-term follow-up of such patients.
This FOA is restricted to applications that are focused on
- Devices for long-term implantation, e.g., cerebrospinal fluid shunts
- Biodegradable scaffolds for tissue engineering
Katerina Tsilou, MD
Obstetrics and Pediatric Pharmacology and Therapeutics Branch
Michael Weinrich, MD
Senior Advisor for Device Development, Biotechnology and Bioengineering
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