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.
The Vascade MVP 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, 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 company has begun shipping the system to centers in the U.S.
The MVP system, designed specifically for electrophysiology procedures, is built upon the Vascade collapsible disc delivery platform and collagen patch, first approved in 2013. According to Cardiva, more than 400,000 U.S. patients undergo related EP procedures each year.
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.
In patients with three or four mid-bore femoral venous access sites, the study demonstrated shorter bed rest times and a decrease in the use of opioid pain medications, as well as patients getting on their feet nearly four hours faster, on average.
Cardiva is also examining the device’s effects on hospital workflows and economics following ablation procedures and earlier hospital discharges, as well as its long-term safety.