Over and Under® Pericardium Covered Stent

Over and Under® Pericardium Covered Stent (PCS) consists of a single flexible stent combined with one piece of equine pericardium pre-mounted on a specially designed balloon catheter and indicated for the following main applications;

Saphenous Vein Graft (SVG)

A multicenter registry - SLEEVE II *, study designed to establish the clinical safety and efficacy of Over and Under® covered stent in patients with degenerated SVG, concluded that Over and Under® bovine pericardium stent is safe to be used in patients with de novo or restenosed saphenous vein grafts lesions

Aneurysms

Perforations

For use in emergency situations such as perforations.
* SLEEVE II study, 30 day report, Cardiovascular Research Foundation, NY
** Haim Danenberg, EuroPCR 2008, Innovative and Emerging Technologies
Remarks: Over and Under® Pericardium Covered Stent has been submitted for approval to Health Canada. Approval pending. Currently available for sale only under Speical Access Program.

Deliverability

The deliverability of Over and Under® PCS was compared with PTFE covered stent in phantom and porcine coronaries. Over and Under® Pericardium Covered Stent appeared superior in deliverability in both model systems going further deep in phantoms by 12±10mm and in porcine vessels by 19±13mm (p