MEDTRONIC ANNOUNCES FDA APPROVAL OF THE
ACHIEVER™ ANGIOPLASTY CATHETER
MINNEAPOLIS, MN, November, 20, 1998 — Medtronic, Inc. (NYSE:MDT) today announced approval by the U.S. Food and Drug Administration (FDA) of the Medtronic Achiever™ semi-compliant balloon catheter, designed to open blockages in the coronary arteries. The Achiever over-the-wire (OTW) catheter for percutaneous transluminal coronary angioplasty (PTCA) is manufactured with a proprietary EOS semi-compliant balloon material that delivers controlled growth and high pressure capabilities required for a wide range of interventional applications.
Utilizing a unique Fusion™ thermal processing technology yields a soft supple balloon and tip that delivers excellent lesion crossing and recrossing capabilities. The balloon and catheter tip are seamlessly bonded from the same polymer to enhance flexibility and tracking — ideal for accessing lesions in tortuous bends. In addition, the Fusion bonding process results in a soft, yet very durable tip capable of treating multiple lesions in the same patient.
According to Mel Schatz, vice-president and general manager of the Medtronic Interventional Vascular Business, "Achiever incorporates new technology that not only improves performance over previous designs but enhances manufacturability. Most important, the launch of Achiever in the United States will allow us to compete more effectively in the largest worldwide market for PTCA balloon catheters."
Achiever is offered in lengths of 15 mm, 20 mm, 30 mm, 40 mm and diameters ranging from 1.5 mm to 5.0 mm--a total of 23 sizes--to handle a wide range of coronary anatomies and interventional needs.
The Medtronic Achiever follows the successful launch of the Medtronic Presario balloon catheter introduced internationally in May. Presario is a semi-compliant, single-operator exchange angioplasty catheter that utilizes the same EOS balloon material as Achiever. Achiever is the latest in a series of new product introductions in the U.S., including the Mustang coronary guide wire, Zuma large-lumen guiding catheter and Wiktor-Rival coronary stent system.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company specializing in implantable and interventional therapies. Its Internet address is www.medtronic.com.
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