A Stent with Customizable Length for Treatment of Critical Limb Ischemia: Clinical Need, Device Development and Pre-clinical Testing
- 181 Downloads
Critical limb ischemia (CLI) is typically associated with a poor prognosis in the absence of a revascularization treatment. While surgical revascularization can be successful, there is an increasing desire for minimally invasive therapies, particularly in the more distal, infrapopliteal arteries. These small vessels contribute significantly to CLI, especially in diabetic CLI patients. This study describes a unique multi-segmented self-expanding stent developed specifically for use in infrapopliteal revascularization procedures. The number of segments deployed can be selected to optimize the stented length and location. The device may provide an adjunctive treatment in instances of sub-optimal balloon angioplasty when treating CLI. The clinical opportunity for the device is presented, followed by a description of the design and the design process. The results from a range of bench testing are presented as well as the findings of porcine studies to assess in vivo behaviour. In summary, while further development is needed, this study has demonstrated the feasibility of this novel device.
KeywordsSelf-expanding Infrapopliteal Angioplasty Multi-segmented Radial force Oversizing
The authors wish to acknowledge the design and development activities of Mr. Brendan Casey and Mr. Ronan Keating. This work has been co-funded by Enterprise Ireland and the European Regional Development Fund (ERDF) through Proof of Concept grant PC-2008-012 and Technology Development grant CFTD-09-0139.
Conflict of interest
Barry O’Brien, Eoin O’Cearbhaill and Mark Bruzzi declare that they have no conflict of interest.
No human studies were carried out by the authors for this article.
All institutional and national guidelines for the care and use of laboratory animals were followed and approved by the appropriate institutional committees.
Supplementary material 1 (WMV 20778 kb)
- 1.Balar, N. N., R. Dodla, P. Oza, P. N. Patel, and M. Patel. Endovascular versus open revascularization for peripheral arterial disease. Endovasc. Today 8:61–64, 2011.Google Scholar
- 8.Faglia, E., M. Mantero, M. Caminiti, C. Caravaggi, R. De Giglio, C. Pritelli, G. Clerici, P. Fratino, P. De Cata, L. Dalla Paola, G. Mariani, M. Poli, P. G. Settembrini, L. Sciangula, A. Morabito, and L. Graziani. Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects. J. Intern. Med. 252:225–232, 2002.CrossRefGoogle Scholar
- 10.Frantzen J.J. Segmented Stent for Flexible Stent Delivery System. U.S. Patent No. 6,187,034. 13 Feb 2001.Google Scholar
- 16.Im, S., S.-W. Rha, B. G. Choi, S. E. Choi, Y. Park, A. R. Goud, et al. Comparison of 12-month clinical outcomes of infrapopliteal balloon angioplasty alone versus balloon angioplasty with provisional stenting in patients with critical limb ischemia. J. Am. Coll. Cardiol. 63:S32–S32, 2014.CrossRefGoogle Scholar
- 19.Krol, K. L. Coding for lower extremity vascularization in 2011. Endovasc. Today 5:81–89, 2011.Google Scholar
- 20.Liistro, F., I. Porto, P. Angioli, S. Grotti, L. Ricci, K. Ducci, G. Falsini, G. Ventoruzzo, F. Turini, G. Bellandi, and L. Bolognese. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 128(6):615–621, 2013.CrossRefGoogle Scholar
- 25.Paley D. Principles of Deformity Correction. Berlin: Springer, 2002. ISBN 3-540-41665-X. p 287.Google Scholar
- 27.Rocha-Singh, K. J., M. Jaff, J. Joyce, J. Laird, G. Ansel, and P. Schneider. Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: the XCELL trial. Catheter. Cardiovasc. Interv. 80(6):1042–1051, 2012.CrossRefGoogle Scholar
- 30.Schmidt, A., M. Piorkowski, M. Werner, M. Ulrich, Y. Bausback, S. Braunlich, H. Ick, J. Schuster, S. Botsios, H. J. Kruse, R. L. Varcoe, and D. Scheinert. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J. Am. Coll. Cardiol. 58:1105–1109, 2011.CrossRefGoogle Scholar
- 32.Siablis, D., D. Karnabatidis, K. Katsanos, A. Diamantopoulos, S. Spiliopoulos, G. C. Kagadis, and J. Tsolakis. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J. Vasc. Interv. Radiol. 20:1141–1150, 2009.CrossRefGoogle Scholar