Medtronic receives FDA, CE clearances for new peripheral balloon catheter

4 June 2013 (Last Updated June 4th, 2013 18:30)

US-based Medtronic has received US Food and Drug Administration (FDA) and CE Mark clearances for its Pacific Plus percutaneous transluminal angioplasty (PTA) catheter.

US-based Medtronic has received US Food and Drug Administration (FDA) and CE Mark clearances for its Pacific Plus percutaneous transluminal angioplasty (PTA) catheter.

The launch of the new peripheral balloon catheter in the US and international markets is now underway.

The Pacific Plus PTA catheter is designed for the treatment of narrowed arteries in several locations within the vasculature, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries.

Featuring a hydrophilic coating to boost crossability, the new catheter allows fast deflation, which may reduce the time of the procedure.

Miami-located Jackson South Community Hospital's cardiovascular medicine director Dr Juan Pablo Zambrano said vascular specialists have been waiting for the Pacific Plus PTA catheter to be approved.

"The Pacific Plus PTA catheter is designed for the treatment of narrowed arteries in several locations within the vasculature, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries."

"The device's ease of deliverability and various shaft lengths provide us with a flexible solution for both straightforward and complex cases," Zambrano said.

The Pacific Plus PTA catheter, which has a broad size matrix, is an over-the-wire peripheral balloon compatible with both 0.014in and 0.018in guidewires and 4 French or 5 French introducer sheaths.

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

The Pacific Plus PTA catheter complements the existing Pacific Xtreme PTA catheter, which comes in lengths from 150mm to 300mm for a variety of balloon diameters.

Minneapolis-headquartered Medtronic, in collaboration with clinicians, researchers and scientists worldwide, offers a wide range of medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.