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FDA Approves New Device to Speed Up Recovery After Heart Procedures

Published: 7/9/2024
      
FDA approval
MYNX CONTROL
Cordis
vascular closure device
cardiac procedures
GRIP TECHNOLOGY
ReliaSeal trial
patient recovery
cardiology innovation
hemostasis

Key Takeaways

  • FDA approves the MYNX CONTROL™ VENOUS VCD to enhance recovery post-heart procedures.
  • Clinical trials show the device significantly reduces recovery times compared to manual methods.
  • Cordis continues to drive innovation in cardiovascular technology with new product launches.

Did You Know?

Did you know the MYNX CONTROL™ Vascular Closure Device can help patients recover faster after heart procedures by significantly reducing bleeding time?

FDA Greenlights MYNX CONTROL™ for Better Recovery

Cordis, a major player in cardiovascular technology, recently secured FDA approval for its MYNX CONTROL™ VENOUS Vascular Closure Device (VCD). This device is designed for patients undergoing certain heart procedures, ensuring faster recovery times.

The MYNX CONTROL™ VENOUS VCD is suitable for mid-sized vein access sites used in various cardiac procedures. This innovative tool significantly enhances the recovery experience for patients, helping them to resume daily activities more quickly.

Significant Improvements in Patient Outcomes

The MYNX CONTROL™ VENOUS VCD uses advanced GRIP TECHNOLOGY™ involving a special sealant that integrates with the skin for faster healing. Compared to traditional methods, the device reduces bleeding times and speeds up the overall recovery process.

A clinical trial named ReliaSeal tested this device against manual compression. The results were impressive, showing significant improvements in recovery times, leading to more efficient hospital workflows and better patient care.

Trial Results Speak Volumes

The ReliaSeal trial involved cardiac ablation procedures where the MYNX CONTROL™ VENOUS VCD was used. Patients experienced much shorter times to stop bleeding, get up and walk, and be ready for discharge compared to those using manual compression.

Specifically, the device shortened Time to Hemostasis to just 2.1 minutes compared to 11.4 minutes with manual methods. It also cut down Time to Ambulation to 2.6 hours versus 5.14 hours and Time to Discharge Eligibility to 3.1 hours instead of 5.5 hours.

Expert Endorsements and Future Plans

Dr. John Summers, a leading cardiac electrophysiologist, highlighted the device's effectiveness in quickly and safely helping patients to move and recover post-procedure. He noted that the MYNX CONTROL™ outperformed manual compression significantly, boosting procedure efficiency.

Chris Bingham, Vice President of Global Marketing & Strategy at Cordis, expressed excitement about the approval. He emphasized Cordis' dedication to innovation and improving patient outcomes.

Cordis aims to launch the MYNX CONTROL™ VENOUS VCD in the U.S. market soon. This launch is expected to set new standards in cardiovascular care, benefiting both patients and healthcare providers.

About Cordis

Cordis is renowned for developing and manufacturing breakthrough cardiovascular and endovascular technologies. With over 60 years of experience, the company focuses on innovations that significantly enhance patient care standards.

For more details about Cordis and its cutting-edge technologies, you can visit their website or follow them on LinkedIn.

References

  1. FDA Press Release
    https://www.fda.gov/news-events/press-announcements
  2. Cordis Official Website
    https://www.cordis.com
  3. Recent Studies on Vascular Closure Devices
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4634528/
  4. Electrophysiology and Cardiac Care Innovations
    https://www.ahajournals.org/journal/circ
  5. Clinical Trials Registry
    https://www.clinicaltrials.gov