Author + information
- Michael Laule1
As the indication for TAVR extends across lower-risk groups, the need for a safe, effective and easy-to-use large hole vascular closure device increases. PerQseal® (Vivasure Medical, Ireland) is a fully bioabsorbable, percutaneous, large arteriotomy closure device designed to meet this clinical need. PerQseal uses a patented patch-based technology to seal the artery from the inside, without the need for sutures, collagen or metal clips. The device comprises a low profile, intra-arterial patch with an extra-arterial locator.
A prospective, multi-centred, non-randomized study was run to assess the safety and performance of the PerQseal large hole closure device. Patients who had a transfemoral procedure (TAVR, EVAR), resulting in an arteriotomy in the range of 18 to 24 F, were included. Patients had post procedure follow-up assessment, at discharge, 1, 3 and 12 months.
A total of 62 patients (70 closures - included 8 bilateral closures in EVAR patients) were enrolled in six EU centres in the Frontier III study. There were no clinically significant haemodynamic changes observed on ultrasound and CT, and zero device failures. Overall, PerQseal has been implanted in 120 patients in four EU countries, with excellent results and no device-related MACE.
|FRONTIER III CE MARK CLINICAL STUDY|
|Follow up (to date)||Patients||MACE (VARC II)||Minor Complications (VARC II)|
Clinical experience to date with this new device offers a safe and effective large hole closure option, delivered at the end of the procedure. It is fully percutaneous, easy to use and absorbable; with demonstrated minimal hemodynamic impact.
OTHER: Vascular Access