Medtronic Announces European Launch of First-Ever Left-Heart Cardiac Resynchronisation Lead with Unique Fixation Lobes
MINNEAPOLIS – July 26, 2006 – Medtronic announced today the European introduction of the Medtronic Attain StarFix™ OTW (over-the-wire) lead (Model 4195), the first-ever cardiac resynchronisation therapy (CRT) left-heart lead to offer customizable fixation technology. With the Attain StarFix lead, physicians have a new solution for achieving successful placement and stability of the left-heart lead in heart failure patients receiving an implanted CRT device. The design of left-heart leads is important, since some patients’ vein structures can make it difficult to secure the lead, which delivers electrical pulses from the CRT device to the left ventricle to improve heart failure symptoms and slow the progression of heart failure.
The Attain StarFix’s unique design includes three soft lobes near the lead tip that, when expanded, enable stable placement of the lead tip within a target vein in the left ventricle. As necessary, the lobes can be relaxed to allow for acute repositioning of the lead. This exclusive lead technology is expected to advance the treatment of heart failure by making CRT available to patients whose heart vein sizes, configurations and locations formerly presented difficult challenges in lead placement. It is the industry’s first left-heart lead that can be customized to fit a variety of vein sizes, and the flexibility in lead placement may decrease the potential for extracardiac or phrenic nerve stimulation. The Attain StarFix lead is another example of Medtronic’s leadership in introducing innovative heart failure technologies to help physicians better manage cardiac disease.
“With the Attain StarFix’s new lobe technology, physicians now have a lead option that can be safely secured in even the most challenging cardiac veins,” said Herbert Naegele, M.D., St. Adolf-Stift Medical Center, Reinbek, Germany, who implanted a Medtronic InSync MaximoTM CRT system in a heart failure patient today using the world’s first commercially available Attain StarFix lead. “With enhanced lead stability, we can help more heart failure patients achieve the tremendous benefits of CRT.”
The Medtronic Attain StarFix unipolar lead has a 5-French diameter – smaller than the lead in a common pencil – and is available in 79 cm., 88 cm., and 103 cm. lengths. After guide wire and/or stylet placement and delivery of the lead using a catheter, the lead’s lobes can be deployed up to 24-French diameter – about one-quarter inch – firmly fixing the electrode in place and reducing the potential for dislodgment during catheter withdrawal.
Heart failure is a chronic condition afflicting more than 22 million people worldwide. Approximately one-third of these patients have dysynchronous beating of the left and right ventricles that interferes with the heart’s ability to pump adequate blood supply throughout the body. According to the European Society of Cardiology, American College of Cardiology and American Heart Association, CRT is a standard-of-care therapy for these patients.
Medtronic CRT devices and leads are the most frequently used CRT products in the world to serve this patient group. Its InSync Sentry™ CRT defibrillation system is the world’s first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity, the chest area encompassing the lungs and heart. The Medtronic InSync® and InSync® III devices restore left- and right-heart synchrony for patients who are not indicated for implantable defibrillators. The Attain StarFix lead, which is not available in the United States, is designed to complement the Attain Model 4193 and Model 4194 over-the-wire leads, along with steerable catheters and guide wires, to facilitate placement and delivery of precise stimulation in widely varying coronary anatomies.
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 Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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- Medtronic, Inc.
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