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Micromesh Stent Technology – Also a Solution for Peripheral Arteries? Dr Daniel Périard Angiology Hôpital Cantonal Fribourg Switzerland Disclosure

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Micromesh Stent Technology – Also a Solution for Peripheral Arteries? Dr Daniel Périard Angiology Hôpital Cantonal Fribourg Switzerland Disclosure Micromesh stent technology – also a solution for peripheral arteries? Dr Daniel Périard Angiology Hôpital Cantonal Fribourg Switzerland Disclosure I have no potential conflict of interest regarding this presentation. RoadSaver ™ carotid stent It is a double layer of braided nitinol wires The outer layer provides high radial force, flexibility and conformation to tortuous anatomy The inner micromesh layer has the smallest cell size, preventing plaque protrusion and embolism 5Fr rapid exchange platform Fully re-sheathable and repositionable Ongoing studies evaluating the Roadsaver ™ for CAS Clearroad Trial Italian Registry 9 Centers 3 Centers: Peeters (Bonheiden), Bosiers/ Cremonesi/ Castriota (Cotignola) Deloose (Dendermonde), Maene Setacci/ Cappelli (Siena) (Aalst), Setacci/ Cappelli (Siena), Rabbia/ Ruffino (Turin) Langhoff (Berlin), Müller-Hülsbeck > 150 Patients enroled (Flensburg), Sievert (Frankfurt), Results Scheinert/ Schmidt (Leipzig), No complications Torsello/ Schwindt (Münster) No plaque prolapse 81 patients enroled Fewer and smaller new white lesions compared to C-Guard, Results (preliminary) diagnosed by DW-MRI No stroke (1) Am J Cardiol. 2015 Sep 15;116(6):977-81. doi: 10.1016/j.amjcard.2015.05.063. Epub 2015 Jun 25. (2) Tailored carotid artery stenting, Pieniazek et al., J. Endovasc. Ther. 1 MI (3) A novel carotid stent for sustained embolic protection, Subbarao Myla, Newport Beach, USA, Presentation CIRSE 14.-18.September 2013, Barcelona, Spain (4) Safety of Slender 5Fr Transradial Approach for Carotid Artery Stenting With a Novel Nitinol Double-Layer Micromesh Stent. Kedev S., et al., Am J Cardiol. 2015 Sep 15;116(6):977- 81. doi: 10.1016/j.amjcard.2015.05.063. Epub 2015 Jun 25. (5) Initial clinical experience with the micromesh roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. Hopf-Jensen S, et al., J Endovasc Ther. 2015 Apr;22(2):220-5. doi: 10.1177/1526602815576337. (6) Cremonesi A et al. Carotid Artery Stenting an update EHJ2015 (7) Deloose, K. et al.,Clinical Evidence for Roadsaver Carotid Stent the CLEAR-ROAD trial, CIRSE 2014 (8) Amor, M. et al. Pre-Clinical and first clinical experiences with the Micromesh Carotid stent Roadsaver, LINC 2014 open cell laser-cut nitinol stent may be unable to achieve a good lumen patency and lack of resistance to high external compression RoadSaver ™ result after multiple in- stent angioplasties The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions: a pilot study Monocentric study Investigator initiated Inclusion criteria: • PAD with severely calcified SFA/pop lesions • At least one run off vessel before Roadsaver ™ implantation Objectives: technical aspects success of implantation security of the Roadsaver ™ efficacy of the Roadsaver ™ Follow-up: clinical examination and duplex scan 1, 6, 12, 18, 24 M The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions Inclusion current status (started May 2015) : baseline characteristics patients n=21 age (y) 75 ± 11 gender (male) 67% diabetes 38% hypertension 81% smoking (past or current) 43% hyperlipidemia 62% renal failure (ClCr ≤ 30 ml/min) 14% Rutherford 3 or 4 52% 5 9.5% 6 14% The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions Lesions characteristics: patients n=21 SFA 71% poplitea 67% calcifications mild 33% heavy (>180°) 6 (30 %) massive (360°) 33%29% mean degree of stenosis 89±11 % occlusions 48% sub-intimal recanalisation 14% treated lesion lenght (PTA) (mm) 169±129 mm stented segment lenght (mm) 35±9 mm debulking 19% The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions Results: patients n=21 procedure primary success 100 % 30 days primary patency 100% 30 days freedom from TLR 100% 30 days freedom from TVR 96% * patients n=15 6 months primary patency 100 % 6 months in stent restenosis (PSV≥2) 0 % * recanalisation of a lesion proximal to the Roadsaver 84 y woman, rutherford 4 Immediate result of the Roadsaver™ implantation no restenosis at 6 months Duplex The Roadsaver ™ may be used as a flow diverter for small poplitea aneurysm. High plaque coverage operates as a metallic covered stent, but keeps the side branch open 76 y man, rutherford 3 Roadsaver™ used Thrombosis of the as a scaffold for aneurysm and the stenosis and preserved flow in flow diverter for the stent and the the aneurysm side branch Popliteal calcified stenosis with post- stenotic small aneurysm day 0 day 18 conclusions Innovative dual layer stent with excellent scaffold for SFA/pop calcified lesions. Safe Ease of use Absence of restenosis at 6 months Candidate for popliteal aneurysm cure (flow diverter) Further studies must confirm these results Micromesh stent technology – also a solution for peripheral arteries? Dr Daniel Périard Angiology Hôpital Cantonal Fribourg Switzerland .
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