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
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.
Media Contact:
Christine Gurdak
Director, Global Brand & Marketing Communications
Christine.gurdak@cordis.com
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SOURCE Cordis