Cordis Mynx Control Venous Vascular Closure Device Receives FDA Approval

July 9, 2024—Cordis announced FDA premarket approval of its Mynx Control Venous vascular closure device (VCD) for procedures with access sites from 6 F to 12 F. The device brings the technology of the company’s Mynx family of products to midbore venous puncture sites, including electrophysiology procedures.

Cordis plans to launch the Mynx Control Venous VCD in the United States in the coming months.

According to the company, the Mynx Control Venous VCD’s sealant leverages the company’s Grip Technology, which is based on hydrophilic, bioinert polyethylene glycol. 

Cordis noted that in the ReliaSeal prospective randomized controlled trial comparing the Mynx Control Venous VCD versus manual compression in cardiac ablation procedures, the Cordis device met all clinical endpoints, resulting in 100% procedure and device success. Also, the trial results demonstrated significant reductions with the Mynx Control Venous VCD group versus the manual compression group in time to hemostasis (2.1 vs 11.4 mins.); time to ambulation (2.6 vs 5.14 hrs); and time to discharge eligibility (3.1 vs 5.5 hrs.), supporting improved facility workflow.

“Using Mynx Control Venous VCD following ablation procedures, investigators achieved consistent and effective closure, facilitating quick and safe patient ambulation,” commented John Summers, MD, in the Cordis press release. “The ReliaSeal results demonstrate superiority to manual compression and will allow electrophysiologists to confidently increase procedure efficiency.”

Dr. Summers is Director of Cardiac Electrophysiology at the SSM Health St. Anthony Hospital in Oklahoma City, Oklahoma, and Cardiology Chief at SSM Health St. Anthony Hospital Midwest in Midwest City, Oklahoma.

“Mynx Control Venous VCD demonstrates Cordis' commitment to innovation and will offer immediate value to physicians and patients,” added Chris Bingham, Vice President, Global Marketing & Strategy at Cordis. “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.”