US FDA approves Cordis’ Mynx Control venous vascular closure device

Cordis recently announced that the US Food and Drug Administration (FDA) has granted premarket approval for its Mynx Control venous vascular closure device (VCD) for procedures with access sites from 6F-12F.

A press release details that the Mynx Control venous VCD expands the Cordis portfolio of extravascular closure devices designed to deliver predictable deployment and ease of use.

The Mynx Control venous VCD sealant leverages Cordis’ Grip Technology, based on hydrophilic, bioinert polyethylene glycol (PEG). This, according to the company, resorbs three times faster than collagen-based sealants and provides the quickest time to haemostasis of any venous closure device on the market.

In the prospective, randomised controlled ReliaSeal trial comparing manual compression versus Mynx Control venous VCD in cardiac ablation procedures, Mynx Control venous VCD met all clinical endpoints resulting in 100% procedure and device success. The trial results also demonstrated significant reductions between theMynx Control venous VCD group and the manual compression group in time to haemostasis (2.1 vs. 11.4 minutes), time to ambulation (2.6 vs. 5.14 hours), and time to discharge eligibility (3.1 vs. 5.5 hours), supporting improved facility workflow.

“Using Mynx Control venous VCD following ablation procedures, investigators achieved consistent and effective closure, facilitating quick and safe patient ambulation,” said John Summers, director of Cardiac Electrophysiology at the SSM Health St Anthony Hospital and Cardiology chief at SSM Health St Anthony Hospital Midwest (Oklahoma City, USA). “The ReliaSeal results demonstrate superiority to manual compression and will allow electrophysiologists to confidently increase procedure efficiency.”

“Mynx Control venous VCD demonstrates Cordis’ commitment to innovation and will offer immediate value to physicians and patients,” said 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 the market, benefiting both patients and physicians.”

Cordis advises that it plans to launch the Mynx Control venous VCD in the USA in the coming months.