SHARE @ Advocate Health - Midwest - Scientific Day: The Efemoral Vascular Scaffold System (EVSS): A Novel, Resorbable, Sirolimus-Eluting Device for Percutaneous Peripheral Intervention (PPI)
 

Affiliations

Advocate Lutheran General Hospital

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

wf_yes

Document Type

Oral/Podium Presentation


 

Share

COinS
 
May 21st, 10:40 AM May 21st, 10:45 AM

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.

 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.