Cordis announced today that the FDA granted premarket approval (PMA) for its Mynx Control venous vascular closure device (VCD).
PMA covers the use of the Mynx Control device in in procedures with access sites from 6F to 12F. Mynx Control expands the Cordis portfolio of extravascular closure devices designed to delivery predictable deployment and ease of use.
Features include the company’s Grip Technology, based on hydrophilic, bioinert polyethylene glycol (PEG). This enables the VCD sealant to resorb three times faster than collagen-based sealants. According to a news release, it also provides the quickest time to hemostasis of any venous closure device on the market.
Cordis said clinical evaluation comparing manual compression versus Mynx Control in cardiac ablation demonstrated 100% procedure and device success for the latter. Results also showed significant reductions in time to hemostasis, ambulation and discharge eligibility with Mynx Control. Cordis says this supports improved facility workflows.
The company plans to launch the Mynx Control venous VCD in the U.S. in the coming months following the approval.
“Mynx Control venous VCD demonstrates Cordis’ commitment to innovation and will offer immediate value to physicians and patients,” said Chris Bingham, VP, 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.”
