Recommended Citation
El Khoury R, Tzvetanov I, Goor JB, et al. The Efemoral Vascular Scaffold System (EVSS): A Novel, Resorbable, Sirolimus-Eluting Device for Percutaneous Peripheral Intervention (PPI). Presented at Scientific Day; May 21, 2025; Park Ridge, IL.
Abstract
Background/Significance:
Conventional endovascular therapies for peripheral arterial occlusive disease remain fraught with peri-procedural endothelial injury and arterial inflammation. Drug-eluting bioresorbable vascular scaffolds constitute a new device category that may mitigate early negative vascular remodeling.
Purpose:
The purpose of this experiment was to assess the subacute response to implantation of a novel, sirolimus-eluting, bioresorbable scaffold system in an animal model of femoropopliteal intervention.
Methods:
The 6x50 mm Efemoral Vascular Scaffold System (EVSS) consisting of four 6x12 mm closed-cell polymer-based scaffolds loaded with sirolimus (3 mg/cm2), serially mounted and crimped on a balloon were implanted into the bilateral iliac arteries of five female Yucatan mini-swine in a 1:1.2 expansion ratio. The 10 treated arteries were imaged using quantitative angiography and optical coherence tomography (OCT). After 30 days, the treated arteries were re-imaged and harvested for histologic analysis. Sections stained with hematoxylin and eosin (H&E) and Verhoeff-van Gieson were assessed for vascular reaction using semi-quantitative 0-3 point scales and histomorphometry.
Results:
All animals survived to sacrifice and all treated arteries remained widely patent. Angiographic analysis at 30-days revealed 9.7±7.6% diameter stenosis and 0.56±0.27 mm late lumen loss. OCT revealed universal scaffold integrity and strut coverage after 30 days; area stenosis was only 2.9±1.5%. Histologic analysis at 30-days revealed no mural injury (1.0±0.0), modest inflammation (1.5±0.3), near-complete reendothelialization (2.4±0.1) and ubiquitous fibrin indicating drug elution (2.5±0.2). Histomorphometric analysis revealed only a modest neointimal reaction without luminal compromise (area stenosis of 16%±2% in the scaffolded regions and 12±4% in the inter-scaffold segments).
Conclusion:
In this non-diseased animal experiment, the EVSS provided effective scaffolding of the treated artery, demonstrated near-complete reendothelialization within 30 days, and generated only a modest vascular proliferative response. The EVSS shows the potential to address the shortcomings of currently available endovascular treatment options.
Presentation Notes
Presented at Scientific Day; May 21, 2025; Park Ridge, IL.
Full Text of Presentation
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Document Type
Oral/Podium Presentation
The Efemoral Vascular Scaffold System (EVSS): A Novel, Resorbable, Sirolimus-Eluting Device for Percutaneous Peripheral Intervention (PPI)
Background/Significance:
Conventional endovascular therapies for peripheral arterial occlusive disease remain fraught with peri-procedural endothelial injury and arterial inflammation. Drug-eluting bioresorbable vascular scaffolds constitute a new device category that may mitigate early negative vascular remodeling.
Purpose:
The purpose of this experiment was to assess the subacute response to implantation of a novel, sirolimus-eluting, bioresorbable scaffold system in an animal model of femoropopliteal intervention.
Methods:
The 6x50 mm Efemoral Vascular Scaffold System (EVSS) consisting of four 6x12 mm closed-cell polymer-based scaffolds loaded with sirolimus (3 mg/cm2), serially mounted and crimped on a balloon were implanted into the bilateral iliac arteries of five female Yucatan mini-swine in a 1:1.2 expansion ratio. The 10 treated arteries were imaged using quantitative angiography and optical coherence tomography (OCT). After 30 days, the treated arteries were re-imaged and harvested for histologic analysis. Sections stained with hematoxylin and eosin (H&E) and Verhoeff-van Gieson were assessed for vascular reaction using semi-quantitative 0-3 point scales and histomorphometry.
Results:
All animals survived to sacrifice and all treated arteries remained widely patent. Angiographic analysis at 30-days revealed 9.7±7.6% diameter stenosis and 0.56±0.27 mm late lumen loss. OCT revealed universal scaffold integrity and strut coverage after 30 days; area stenosis was only 2.9±1.5%. Histologic analysis at 30-days revealed no mural injury (1.0±0.0), modest inflammation (1.5±0.3), near-complete reendothelialization (2.4±0.1) and ubiquitous fibrin indicating drug elution (2.5±0.2). Histomorphometric analysis revealed only a modest neointimal reaction without luminal compromise (area stenosis of 16%±2% in the scaffolded regions and 12±4% in the inter-scaffold segments).
Conclusion:
In this non-diseased animal experiment, the EVSS provided effective scaffolding of the treated artery, demonstrated near-complete reendothelialization within 30 days, and generated only a modest vascular proliferative response. The EVSS shows the potential to address the shortcomings of currently available endovascular treatment options.
Affiliations
Advocate Lutheran General Hospital