Cordis has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Mynx Control Venous vascular closure device (VCD).
The approval allows Mynx Control Venous for procedures involving access sites from 6F to 12F.
The VCD expands Cordis’ portfolio of extravascular closure devices, intended to deliver predictable deployment and ease of use.
It utilises GRIP TECHNOLOGY, based on hydrophilic, bioinert polyethylene glycol (PEG). This allows the VCD sealant to offer a resorption rate that is three times faster than collagen-based sealants.
Additionally, the Mynx Control Venous vascular closure device is said to offer the fastest time to haemostasis among all venous closure devices currently available in the market.
Cordis, which develops interventional cardiovascular and endovascular technology, evaluated Mynx Control Venous against manual compression for cardiac ablation procedures in the prospective, randomised control ReliaSeal trial.
The device met all clinical endpoints with 100% procedure and device success rates.
In addition, ReliaSeal demonstrated significant advantages for the MYNX CONTROL Venous VCD group over manual compression in time to haemostasis, time to ambulation, and time to discharge eligibility.
The findings support improved workflow efficiency in healthcare facilities.
Cordis global marketing and strategy vice president Chris Bingham said: “Mynx Control Venous VCD demonstrates Cordis’ commitment to innovation and will offer immediate value to physicians and patients.
“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 intends to introduce the Mynx Control Venous device in the US in the upcoming months.
Last month, the endovascular technology developer announced positive 24-month results from the SELUTION SFA Japan Trial of SELUTION SLR Drug-Eluting Balloon (DEB). SELUTION SLR was assessed for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA).
