A new double-cone nitinol device for PDA occlusion: design, manufacturing and initial in vivo results.

ABSTRACT

Use of occluder devices for a patent ductus arteriosus (PDA) closure is restricted to small diameter PDAs and involves high device costs. The objective of this study was to develop a new nitinol implant for the closure of a PDA and to evaluate its safety and efficacy in an animal model. The design consists of a device that promotes thrombus formation in the PDA. The device has a double-cone shape with their vertices joined. The cones are made of a nitinol wire helix with dacron fibers attached. The proximal end of the helix can be screwed to a conventional catheter release wire. In vitro testing was performed to verify the effectiveness of the implantation of the device and its releasing system; all trials (n = 30) were successful, showing accurate placement and release of the device. Complete and successful implantation of the device was achieved in all in vivo experiments (n = 5). There was one case of embolization due to premature detachment; a second device was successfully implanted. Histological evaluation after 42.3 +/- 3.1 days demonstrated complete PDA occlusion. The retrieved PDA showed total closure of the defect, endothelization of the PDA outlets and proper lodging of the device.