The Mynx Study
The safety and effectiveness of the Mynx Vascular Closure Device was evaluated in patients following diagnostic and interventional procedures performed through a 6F or 7F femoral procedure sheath.
The study was a prospective, non-randomized, multi-center clinical investigation with a historical control (manual compression). 190 patients were enrolled at five centers in Europe. Patients were divided equally between diagnostic and 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.
The Mynx Vascular Closure Device met the primary safety and efficacy endpoints of this study and demonstrated that patients who have undergone diagnostic or interventional procedures utilizing a 6F or 7F procedural sheath and treated with Mynx have superior times to hemostasis and ambulation compared to patients in the standard compression control arm of the trial.