FDA Approves Cordis’ Mynx Control Venous Vascular Closure Device

Cordis has earned U.S. Food and Drug Administration (FDA) approval for its MYNX Control venous vascular closure device (VCD) for procedures with access sites from 6-12F.

The MYNX Control venous VCD leverages Grip Technology, which is based on hydrophilic, bioinert polyethylene glycol (PEG). According to the company, the MYNX Control sealant resorbs three times faster than collagen-based sealants, and offers the fastest time to hemostasis of currently available venous closure devices.

The company’s ReliaSeal trial, which compared manual compression vs. Mynx Control in cardiac ablation, met all clinical endpoints and achieved 100% procedure and device success. Results also showed Mynx Control achieved hemostasis in 2.1 minutes, compared to 11.4 minutes for manual compression.

Time to ambulation in the trial was 2.6 hours for Mynx Control and 5.14 hours for manual compression. Time to discharge eligibility was 3.1 vs. 5.5 hours, respectively.

Cordis said it aims to launch the venous VCD in the U.S. in the upcoming months.

“MYNX CONTROL VENOUS VCD demonstrates Cordis’ commitment to innovation and will offer immediate value to physicians and patients,” said Cordis VP of global marketing and strategy Chris Bingham. “Cordis is building a robust portfolio of products across the coronary, peripheral and closure markets. We look forward to bringing transformative innovation to market, benefitting both patients and physicians.”