Monday, July 15, 2024

Cardiac Ablation Procedures: FDA Approves Cordis’ Vascular Closure Device

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Cardiac ablation procedures will benefit from the US Food and Drug Administration’s (FDA) approval of Cordis’ Mynx Control VenousVascular Closure Device (VCD), which is specifically designed for access sites ranging from 6F to 12F. This device employs innovative grip technology, utilizing a hydrophilic, bioinert polyethylene glycol (PEG) sealant.

This sealant resorbs three times faster than collagen-based alternatives and reportedly offers the fastest time to hemostasis among venous closure devices. The FDA’s approval is based on promising results from the ReliaSeal clinical trial, which demonstrated 100% procedural and device success for the Mynx Control VenousVCD in cardiac ablation procedures.

Cardiac Electrophysiology Expert Praises Mynx Control VenousVCD for Enhanced Ablation Procedure Efficiency

Dr. John Summers, director of cardiac electrophysiology at SSM Health St. Anthony Hospital, highlighted the device’s effectiveness in a press release: “Using Mynx Control VenousVCD following ablation procedures, investigators achieved consistent and effective closure, facilitating quick and safe patient ambulation. The ReliaSeal results demonstrate superiority to manual compression and will allow electrophysiologists to confidently increase procedure efficiency.”

The ReliaSeal trial was a multicenter, prospective, randomized, controlled, open-label study designed to assess the safety and efficacy of the Mynx Control VenousVCD compared to manual compression in cardiac ablation procedures. The trial enrolled 314 patients over the age of 18 across 15 sites. Participants were monitored for 30 days post-treatment to gather comprehensive data on the device’s performance.

The trial’s findings were significant, showing 100% device success in cardiac ablation procedures. Notably, the Mynx Control Venous VCD group experienced substantial improvements over the manual compression group in several key metrics.

Cardiac

Cardiac Procedure Efficiency Boosted: Mynx Control Venous VCD Outperforms Manual Compression in Key Metrics

The Mynx Control Venous VCD significantly improved key metrics compared to manual compression, reducing time to hemostasis from 11.4 minutes to 2.1 minutes, time to ambulation from 5.14 hours to 2.6 hours, and time to discharge eligibility from 5.5 hours to 3.1 hours. These reductions support enhanced facility workflow, allowing for quicker patient recovery and discharge, thereby improving overall procedure efficiency and patient throughput.

Chris Bingham, VP of Global Marketing & Strategy at Cordis, emphasized the company’s dedication to innovation and patient care in a press release: “Mynx Control VenousVCD 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, benefiting both patients and physicians.”

The approval of the Mynx Control VenousVascular Closure Device by the FDA represents a noteworthy development in the field of cardiac ablation. The device’s use of advanced PEG sealant technology, combined with the positive results from the ReliaSeal trial, underscores its potential to improve procedural outcomes and patient experiences significantly. By reducing time to hemostasis, ambulation, and discharge eligibility, the Mynx Control VenousVCD not only enhances patient safety but also optimizes clinical workflow.

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Cordis’ innovative approach and commitment to expanding their product portfolio promise continued advancements in medical device technology, offering new solutions that benefit both healthcare providers and patients. The upcoming launch of the Mynx Control VenousVCD is anticipated to make a substantial impact on the management of cardiac ablation procedures, demonstrating the ongoing evolution and improvement of medical treatments through technological innovation.

 

Resource: National Institutes of Health, July 09, 2024

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