FDA approves Cardiva’s new bioabsorbable vessel closure system
Summary
The FDA has granted a premarket approval to Cardiva Medical for its Vascade MVP venous closure system, designed to help heal multi-site vascular access points following minimally invasive electrophysiology procedures, such as cardiac ablation. Nothing is left inside the vessel, and the collagen is gradually resorbed to allow additional access in future procedures, the company said. “We are proud to have partnered with leading EP physicians in the United States to address this unmet need—and enable patients to get back on their feet sooner and improve the workflow for these highly successful procedures,” said Cardiva CEO John Russell, who described the approval as the culmination of a multiyear effort. The MVP system, designed specifically for electrophysiology procedures, is built upon the Vascade collapsible disc delivery platform and collagen patch, first approved in 2013. The device’s approval was based on data from a 204-patient controlled study comparing the Vascade MVP system to manual compression following cardiac ablation procedures.
Classifications
AskAI Classifications
LabelsLinked Companies
