Cordis Receives FDA Approval for Blood Vessel Closure Device

Cordis today announced that the Food and Drug Administration (FDA) has granted premarket approval (PMA) for its Mynx Control venous closure device (VCD).

PMA covers the use of the Mynx Control in procedures with access sites ranging from 6F to 12F. The Mynx Control expands the Cordis portfolio of extravascular closure devices designed for predictable deployment and ease of use.

Features include the company’s Grip technology, which is based on hydrophilic, bioinert polyethylene glycol (PEG). This allows the VCD sealant to absorb three times faster than collagen-based sealants. It also provides the fastest hemostasis time of any vein closure device on the market, according to a press release.

Cordis said a clinical evaluation comparing manual compression with Mynx Control for cardiac ablation showed 100% success for the procedure and device for the latter. Results also showed significant reductions in time to hemostasis, ambulation and discharge eligibility with Mynx Control. Cordis says this supports streamlined workflows in the facility.

The company plans to launch Mynx Control Venous VCD in the U.S. in the coming months once approval is obtained.

“The Mynx Control Venous VCD demonstrates Cordis’ commitment to innovation and will provide immediate value to physicians and patients,” said Chris BinghamVice President, Global Marketing and Strategy, Cordis. “Cordis is building a strong product portfolio in the coronary, peripheral and closure markets. We look forward to bringing this transformational innovation to market that will benefit both patients and physicians.”