FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures

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The FDA has approved Cordis’ Mynx Control VenousVascular Closure Device (VCD), designed for cardiac ablation procedures with access sites ranging from 6F to 12F. According to the company, the device utilizes grip technology, which leverages a hydrophilic, bioinert polyethylene glycol (PEG) sealant that resorbs three times faster than collagen-based alternatives and reportedly provides the fastest time to hemostasis among venous closure devices. Additionally, the device was approved based on promising results from the ReliaSeal trial, which found that the Mynx Control VenousVCD demonstrated 100% procedural and device success in cardiac ablation procedures.¹

"Using Mynx Control VenousVCD following ablation procedures, investigators achieved consistent and effective closure, facilitating quick and safe patient ambulation," said John Summers, MD, director of cardiac electrophysiology, SSM Health St. Anthony Hospital, cardiology chief, SSM Health St. Anthony Hospital Midwest, in a press release. "The ReliaSeal results demonstrate superiority to manual compression and will allow electrophysiologists to confidently increase procedure efficiency."

The multicenter, prospective, randomized, controlled, open label ReliaSeal clinical trial was designed to evaluate the safety and efficacy of Mynx Control VenousVCD in cardiac ablation procedures compared with manual compression. The trial enrolled a total of 314 patients over the age of 18 years across 15 sites. All patients were evaluated for 30 days after treatment ended.^1,2

The trial results showed 100% device success in cardiac ablation procedures, as well as significant reductions between the Mynx Control Venous VCD group and 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.¹

" Mynx Control VenousVCD demonstrates Cordis' commitment to innovation and will offer immediate value to physicians and patients," said Chris Bingham, VP, global marketing & strategy, Cordis, in the press release. "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."

Cordis has stated that it intends to launch the Mynx Control VenousVCD later this year.¹

References

1. Cordis receives FDA approval for MYNX CONTROL™ VENOUS Vascular Closure Device/ PR Newswire. July 9, 2024. Accessed July 9, 2024. https://www.prnewswire.com/news-releases/cordis-receives-fda-approval-for-mynx-control-venous-vascular-closure-device-302191434.html 

2. Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression (ReliaSeal). Clinicaltrials.gov. Accessed July 9, 2024. https://clinicaltrials.gov/study/NCT05554471