Preclinical safety and performance evaluation of a highly-flexible peripheral polytetrafluoroethylene-covered stent

Sep 30, 2026

Background and objective: Sten graft implantation faces deliverability challenges, fracture risk, and subsequent restenosis. This study evaluated the safety and performance of a highly flexible cobalt-chromium stent covered with PTFE in a preclinical model. Methods: Six PTFE-covered cobalt-chromium stent grafts were implanted into iliac arteries of 11 swine and compared with controls; angiography, high-definition IVUS, and histology were assessed after 28 days. Results: All animals survived. At day 28, MLD showed no significant differences versus baseline, with no LLL. Histology indicated minimal vascular injury, complete endothelialization, and minimal inflammation. Conclusions: Solaris BXTM demonstrated high flexibility, biocompatibility, and reduced neointimal hyperplasia versus control.

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ORIGINAL ARTICLE Cardiology Journal 2025, Vol. 32, No. 6, 555–561 DOI: 10.5603/cj.91079 Copyright © 2025 Via Medica ISSN 1897–5593 eISSN 1898–018X Preclinical safety and performance evaluation of a highly-flexible peripheral polytetrafluoroethylene-covered stent Armando Tellez 1 , Marta Mazur2–3 , Mateusz Kachel2–3 , Adam Janas3–4 , Carlos Fernandez3 , Karolina Łukasik3 , Sabrina N. Evans5 , Juliana Castro6 , Eduardo Cordeiro6 , Luciano Curado6 , Piotr Buszman2–4 1Instituto Tecnológico de Estudios Superiores de Monterrey, Monterrey, Nuevo Leon, Mexico 2American Heart of Poland, Katowice, Poland 3Research and Development (CCRD), American Heart of Poland, Katowice, Poland 4Andrzej Frycz Modrzewski Krakow University, Krakow, Poland 5LDM Scientific, Adamstown, Maryland, United States 6Scitech Produtos Médicos, Aparecida de Goiânia, Goiás, Brazil Abstract Background: Sten graft implantation faces challenges such as deliverability issues, fracture risk, and subsequent restenosis. Recent advancements have introduced thinner coatings for increased flexibility and improved biocompatibility. The aim herein was to assess the safety and performance of a highly flexible cobalt-chromium stent covered with polytetrafluoroethylene (PTFE) in a preclinical model. Methods: In total 6 PTEF-covered stent grafts 6mm x 38mm cobalt-chromium,(Solaris BXTM, Scitech Produtos Medicos) were implanted compared to 5 controls ( BeGraftTM, Bentley InnoMed GmbH) in theiliac arteries of 11 swine. Stentswereevaluated with angiography, high-definition IVUS, and histologyfor 28 days. Results: All animals underwent successful implantation with 100% survival at follow-up. At 28 days, there was no statistically significant difference inMLD compared to baseline in both groups (test, 5.2 ± 0.7 mm vs. 5.3 ± 0.6 mm, p = 0.8; control, 4.9 ± 0.7 mm vs. 5.1 ± 0.5 mm, p = 0.8), indicating no LLL (test,–0.2 ± 0.16 vs. control,–0.18 ± 0.16 mm; p = 0.8). IVUS revealed a tendency for the less neointimal area in the test group (3.75 ± 0.9mm2 vs. 5.69 ± 2.2 mm2; p = 0.08), resulting in a tendency toward higher % AS in the control arm (14.07 ± 3.42% vs. 20 ± 7%; p = 0.1). Microscopic evaluation revealed minimal vascular injury (test 0.1 ± 0.3 vs. control 0.1 ± 0.1) and complete endothelialization coverage (test, 3.2 ± 0.8 vs. control 3.8 ± 0.3) in both groups, with minimal inflammation(test vs. control: per strut 0.02 ± 0.06 vs. 0.14 ± 0.22; neointimal 1.2 ± 0.6 vs. 1.1 ± 0.4; medial 0.3 ± 0.4 vs. 0.3 ± 0.4). Conclusions: Solaris BXTM demonstrated highly flexible and biocompatible, with minimal vascular injury, and reduced neointimal hyperplasia compared to the control. (CardiolJ 2025; 32, 6: 555–561) Keywords: preclinical studies, PTFE-covered stents, peripheral stents, cobalt-chromium stent graft, ballon-expandable stent Address for correspondence: Armando Tellez, MD, Diego de Almagro \#131, Cumbres 4to Sector, Monterrey, N.L. Mexico, tel: (001) 83-00-44-05, [e-mail: armando.tellezcruz@tec.mx](e-mail: armando.tellezcruz@tec.mx) Submitted: 22.07.2022 Accepted: 2.10.2024 Early publication date: 30.05.2025 This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially. [www.cardiologyjournal.org](www.cardiologyjournal.org) 555 Cardiology Journal 2025, Vol. 32, No. 6 Introduction Peripheral arterial disease (PAD) affects almost 12% of the general population. Around 20% of patients are over 65 years old [1] . Atherosclerotic lesions are mostly found in the superficial femoral artery (SFA) [2] . Currently, the most frequently used technique for SFA revascularization is percutaneous transluminal angioplasty [3] . Stent implantation in the peripheral region remains questionable. The

FAQs

What was the main objective of the study?

To assess the safety and performance of a highly flexible cobalt-chromium stent covered with polytetrafluoroethylene (PTFE) in a preclinical model.

How was the stent evaluated in the preclinical model?

Six PTFE-covered stent grafts were implanted in swine iliac arteries and compared with controls, then assessed at 28 days using angiography, high-definition IVUS, and histology.

What were the key safety and efficacy findings at 28 days?

All animals achieved successful implantation with 100% survival. MLD changes and LLL showed no statistically significant differences versus baseline, while histology showed minimal vascular injury, complete endothelialization coverage, and minimal inflammation.

Sep 30, 2026

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