Cordis Granted FDA Approval for MYNX CONTROLâ„¢ VENOUS Vascular Closure Device

10 July 2024

Cordis has received FDA approval for its MYNX CONTROL™ VENOUS Vascular Closure Device (VCD), expanding its portfolio of extravascular closure devices.

This device, designed for access sites from 6F to 12F, features GRIP TECHNOLOGY™ utilizing hydrophilic, bioinert polyethylene glycol (PEG). It offers faster resorption than collagen-based sealants, ensuring rapid hemostasis.

In the ReliaSeal trial, which compared manual compression with MYNX CONTROL™ Venous VCD in cardiac ablation procedures, the device achieved 100% procedure and device success.

It significantly outperformed manual compression in key metrics: 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.), thereby improving facility workflow.

The device for its consistent post-ablation closure, facilitating safe and timely patient ambulation.

The company's commitment to innovation, aiming to deliver significant benefits to physicians and patients alike across coronary, peripheral, and closure markets.

Cordis plans to launch the MYNX CONTROL™ VENOUS VCD in the United States in the near future.




Source: cordis.com