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Medtronic receives FDA, CE Mark approvals for peripheral angioplasty balloon

Medtronic has received both the US Food and Drug Administration (FDA) approval and the CE (Conformité Européenne) Mark clearance for its Pacific Plus percutaneous transluminal angioplasty (PTA), the new peripheral balloon catheter.

The Pacific Plus PTA catheter, which has a hydrophilic coating, enables fast deflation that may reduce procedure time.

The peripheral balloon catheter is designed to treat narrowed arteries in the vasculature, the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries.

Jackson South Community Hospital Miami cardiovascular medicine director Juan Pablo Zambrano said that the device’s ease of deliverability and various shaft lengths provide a flexible solution for both straightforward and complex cases.

The Pacific Plus PTA catheter is an over-the-wire (OTW) peripheral balloon that is compatible with both 0.014-inch and 0.018-inch guidewires and 4 French or 5 French introducer sheaths.

It is available in shaft lengths of 90cm, 130cm and 180cm and catheter lengths from 20mm to 120mm for balloon diameters 2.0-7.0mm, with a 150mm catheter also available on balloon diameters 2.0-3.5mm.

Medtronic, in partnership with clinicians, researchers and scientists worldwide, provides medical technology for the surgical treatment of cardiovascular disease and cardiac arrhythmias.