The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole in the artery after patients undergo a diagnostic endovascular procedures
Key Inclusion: 1. Patients \>18 yrs of age 2. Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery. 3. Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States
Safety & Tolerability
To assess safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 Closure Device. Participants will be assessed for adverse event occurrence for 30 +/-7 days.
Time frame: Enrollment approx for 4 months
Device success
Assess device success, time to dischargeability, major and minor complications in all patients enrolled in the study
Time frame: 30 +/- 7days
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