The Mynx device achieves femoral artery hemostasis via extravascular delivery of a water-soluble sealant composed of polyethylene glycol (PEG). The safety and effectiveness of the device was evaluated in patients following diagnostic and interventional procedures performed through 6F or 7F introducer sheaths located in the common femoral artery.

The study was a prospective, multi-center, non-randomized clinical investigation conducted at 5 European centers. Patient enrollment included 190 patients with 50% of patients having undergone diagnostic catheterization and 50% interventional procedures.

The primary safety endpoint was the combined rate of major complications within 30 days. The primary efficacy endpoints were time to hemostasis and time to ambulation.

Key results from the Mynx study:

• 0.5% rate of major complications
  
• Absence of complications requiring surgical repair
  
• Rapid hemostasis (mean 1.3 minutes) independent of anticoagulation
  
• Time to hemostasis comparable whether the patient underwent a diagnostic (median 0.5 minutes) or interventional (median 0.6 minutes) procedure
  
• Consistently rapid time to ambulation of 1.9 hours for diagnostic patients and 2.0 hours for interventional patients

Mynx Study Conclusions:

• Demonstrated safety and efficacy
  
• Extravascular, water-soluble sealant offering unique safety profile
  
• Rapidly resorbs, leaving nothing behind
  
• Potential for clinical versatility – PVD, immediate restick, obesity