New Pacific Plus peripheral angioplasty balloon gets FDA clearance and the CE mark

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Medtronic announced on 4 June 2013 that the Pacific Plus percutaneous transluminal angioplasty (PTA) catheter has received both FDA clearance and the CE mark. The launch of the new peripheral balloon catheter is underway in the United States and internationally.

Indicated for the treatment of narrowed arteries in a variety of locations within the vasculature, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries, the Pacific Plus PTA catheter epitomises versatility. It features a hydrophilic coating for improved crossability, and enables fast deflation, which may shorten procedure time.

“Vascular specialists have been eagerly awaiting the Pacific Plus PTA catheter,” said Juan Pablo Zambrano, director of cardiovascular medicine at Jackson South Community Hospital in Miami, USA. “The device’s ease of deliverability and various shaft lengths provide us with a flexible solution for both straightforward and complex cases.”

Spanning a broad size matrix, 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 4F or 5F introducer sheaths. It is available in shaft lengths of 90cm, 130cm and 180cm and catheter lengths ranging from 20mm to 120mm for balloon diameters 2.0-7.0mm, with a 150mm catheter also available on balloon diameters 2.0-3.5mm.

The new device complements the existing Pacific Xtreme PTA catheter, which is available in lengths ranging from 150mm to 300mm for a variety of balloon diameters.

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