Posted on Dec 30, 2018, 6 p.m.
The Vascade MVP venous closure system designed to help heal multi-site vascular access points following minimally invasive EP procedures, that has been granted premarket approval by the FDA.
The system places a collagen patch on the outside of each blood vessel puncture site, nothing is left inside the vessel, and the collagen is gradually resorbed to allow additional access in future procedures, in what the company calls an attempt to address an unmet need, improve workflow for these procedures, and to enable patients to heal quicker so they can get back on their feet sooner.
More than 400,000 patients are estimated to undergo EP related procedures every year within the USA. Specifically designed for electrophysiology procedures such as cardiac ablation this system is built upon the Vascade collapsible disc delivery platform and collagen patch.
Approval was based on data from a controlled study involving 204 patients comparing the Vascade MVP system to manual compression following cardiac ablation procedures; those with 3-4 mid-bor femoral venous access sites were found to have had shorter bed rest times, decreased use of opioid medications, and patients were on their feet again close to 4 hours faster on average.
Additional studies are being conducted to examine effects on hospital workflows, economics following ablation procedures, earlier hospital discharges, and long term safety.
Materials provided by:
Note: Content may be edited for style and length.