FDA Clearance and CE Mark For Medtronic’s New Peripheral Angioplasty Balloon

Peripheral Vascular Disease therapies include the use of percutaneous transluminal angioplasty(PTA) using a balloon catheter. While recent news has been all about the race to (U.S.) market for drug eluting varieties, Medtronic is no doubt hoping its Pacific Plus device is sufficiently feature-packed to take a chunk of the market until their drug eluter gains approval.

Background

Medtronic, Inc. has announced that the Pacific Plus PTA catheter has received both U.S. FDA clearance and European CE Mark.

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, Medtronic says the Pacific Plus PTA catheter epitomizes versatility. It features a hydrophilic coating for improved crossability, and enables fast deflation, which may shorten procedure time.

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 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.

The launch of the Pacific Plus PTA Catheter is underway in the United States and internationally.

Physician comments

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

Source: Medtronic, Inc.