Pharmaceutical Executive July 9, 2024
Don Tracy, Associate Editor

Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.

The FDA has approved Cordis’ Mynx Control VenousVascular Closure Device (VCD), designed for cardiac ablation procedures with access sites ranging from 6F to 12F. According to the company, the device utilizes grip technology, which leverages a hydrophilic, bioinert polyethylene glycol (PEG) sealant that resorbs three times faster than collagen-based alternatives and reportedly provides the fastest time to hemostasis among venous closure devices. Additionally, the device was approved based on promising results from the ReliaSeal trial, which found that the Mynx Control VenousVCD demonstrated 100% procedural and device success in cardiac ablation procedures.1

...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: FDA, Govt Agencies, Medical Devices
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article