Cordis receives FDA approval for MYNX CONTROL™ VENOUS Vascular Closure Device

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Jul 09, 2024, 08:00 ET

Approval brings proven technology of the MYNX family of products to mid-bore venous puncture sites, including electrophysiology procedures.

MIAMI, July 9, 2024 /PRNewswire/ -- Cordis, a global leader in the development and manufacturing of interventional cardiovascular and endovascular technology, announces the U.S. Food and Drug Administration (FDA) PMA approval of its MYNX CONTROL™ VENOUS Vascular Closure Device (VCD), for procedures with access sites from 6F-12F.

Cordis receives FDA approval for MYNX CONTROL™ VENOUS Vascular Closure Device, bringing the proven technology of the MYNX family of products to mid-bore venous puncture sites, including electrophysiology procedures.

The MYNX CONTROL™ VENOUS VCD expands the Cordis portfolio of extravascular closure devices designed to deliver predictable deployment and ease of use. Leveraging GRIP TECHNOLOGY™, based on hydrophilic, bioinert polyethylene glycol (PEG), the MYNX CONTROL™ VENOUS VCD sealant resorbs 3x faster than collagen-based sealants and provides the quickest time to hemostasis of any venous closure device on the market.

In the prospective, randomized control 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 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.

"Using MYNX CONTROL™ VENOUS VCD following ablation procedures, investigators achieved consistent and effective closure, facilitating quick and safe patient ambulation," said Dr. John Summers, Director of Cardiac Electrophysiology at the SSM Health St. Anthony Hospital and Cardiology Chief at SSM Health St. Anthony Hospital Midwest. "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 market, benefitting both patients and physicians."

Cordis plans to launch the MYNX CONTROL™ VENOUS VCD in the United States in the coming months.

About Cordis

Cordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have remained committed to improving patients' lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to be the heart of innovation to transform cardiovascular care.

For more information about Cordis, please visit www.cordis.com and follow Cordis on LinkedIn.

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Christine Gurdak

Director, Global Brand & Marketing Communications

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SOURCE Cordis