Medtronic, Inc. Nets FDA Clearance and CE Mark for New Peripheral Angioplasty
Published: Jun 04, 2013
Medtronic Nets FDA Clearance and 'CE' Mark for New Peripheral Angioplasty Balloon
MINNEAPOLIS -- June 4, 2013 -- Expanding its extensive portfolio of lesion-specific solutions for the interventional treatment of peripheral artery disease, Medtronic, Inc. (NYSE: MDT) announced today that the Pacific Plus percutaneous transluminal angioplasty (PTA) catheter has received both U.S. Food and Drug Administration (FDA) clearance and the CE (Conformité Européenne) 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 epitomizes 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 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."
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 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.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology -- alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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