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BioMed Research International
Volume 2018 (2018), Article ID 7312315, 8 pages
https://doi.org/10.1155/2018/7312315
Research Article

Novel Compliant Scaffold with Specific Design for Venous System: Results of a Porcine Model Study

1Vascular Surgery and Organ Transplant Unit, Department of Surgery, University Hospital of Catania, Catania, Italy
2Veterinary University Hospital, School of Veterinary Medicine, University of Milan, Milan, Italy
3Azienda Polo Veterinario di Lodi, Department of Veterinary Sciences and Public Health, University of Milan, Milan, Italy
4Department of Morphology, Surgery and Experimental Medicine and LLTA Center, University of Ferrara, Ferrara, Italy
5Mouse and Animal Pathology Lab (MAPLab), Filarete Foundation, Milan, Italy
6Vascular Disease Center and Institute of Translational Medicine and Surgery, University of Ferrara, Ferrara, Italy

Correspondence should be addressed to Massimiliano Veroux

Received 21 September 2017; Accepted 11 December 2017; Published 31 January 2018

Academic Editor: Robert M. Starke

Copyright © 2018 Pierfrancesco Veroux et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Stenting has become the first-line treatment of obstructive venous disease because of poor results of balloon angioplasty. This preclinical study aimed to investigate the safety and efficacy profile of a novel compliant venous scaffold (CVS) denominated Petalo CVS, specifically designed for venous diseases. Materials and Methods. Twelve healthy pigs weighing 90 kg were used to test Petalo CVS. The devices were implanted into the internal jugular veins (IJVs) using a femoral vein percutaneous approach. The safety profile including the success rate of device releasing, anchoring, and positioning was evaluated immediately. Fracture, migration, primary patency, and endothelial response were assessed at 1, 2, 3, and 6 months after the study procedure. Results. A total of 32 devices were successfully released in both IJVs. No procedure- or device-related complications were reported, and all pigs successfully completed the different scheduled follow-up periods. The primary patency rate was 100%, and no fracture or migration of the device into the brachiocephalic trunk was reported. Histological examination revealed only minimal lesions with minimal or absent inflammatory reaction surrounding the incorporated metallic rods. Conclusions. This porcine model study showed a promising safety and efficacy profile of Petalo CVS, a novel endovenous device based on specific concepts.