Overall, including the acute dislodgements at one day post-implant, the lead has a low 0.7 percent dislodgement rate. These dislodgement rates are supported by one of the industry’s largest and longest-running left-heart lead clinical studies involving 385 implants followed for up to four years. Traditional passive fixation left-heart leads, where there is no active mechanism to fix the lead in place, show average dislodgement rates of 2-8 percent based on several published clinical studies.
The Attain StarFix lead provides physicians with a new solution for achieving successful placement and stability of the left-heart lead in heart failure patients receiving a CRT device. A patient’s vein size or configuration can make it difficult to secure a left-heart lead in the optimal location. Therefore, stable fixation of the left-heart lead is critical to a successful CRT implantation. Dislodgement of the left heart lead may require additional surgeries, which could increase the risk of infection.
“With the Attain StarFix’s unique active fixation mechanism, physicians have a left-heart lead that can be safely placed in a wide variety of veins regardless of location and diameter,” said Stuart Adler M.D., clinical cardiac electrophysiologist, St. Paul Heart Clinic, St. Paul, Minn. “This lead helps to ensure successful placement of CRT therapy in even the most difficult cases, which ultimately results in better management of my patients’ cardiac disease.”
“Providing physicians the technology and tools they need to better treat their patients is at the core of Medtronic’s mission to alleviate pain, restore health and extend life,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic. “This product launch, backed with the support of strong clinical data, is part of our overall commitment and long-term investment in left-heart leads and delivery systems.”
The Medtronic Attain StarFix steroid-eluting unipolar lead has a 5-French diameter and is available in 78, 88 and 103 cm. lengths. The Attain StarFix’s unique design includes three soft, polyurethane lobes near the lead tip that, when expanded, enable stable lead placement in the target location. The soft, pliable lobes, which can be deployed to up to a 24-French diameter – about one quarter inch – can be relaxed multiple times to allow for acute repositioning of the lead as necessary. Once deployed, the electrode is securely fixed in place, reducing the potential for dislodgement.
The Attain StarFix lead, which will be commercially available nationwide in late summer 2008, is designed to complement the Attain Model 4193 and Model 4194 over-the-wire leads. The Attain® catheters along with the Attain Hybrid® Guide Wires are used to deliver leads for precise placement in a wide variety of coronary anatomies. It can be used with any Medtronic CRT-defibrillator (CRT-D), including those within the company’s new Vision 3D™ portfolio. The new Vision 3D wireless ICD and CRT-D portfolio offers unparalleled depth and breadth of unique clinical options that are built on our industry leading pacing and ICD exclusives.
About Heart Failure
Chronic heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body’s tissues; it affects more than 5 million Americans and 22 million people worldwide. Approximately one-third of these patients have dysynchronous beating of the left and right ventricles (lower chambers of the heart) that interferes with the heart’s ability to pump adequate blood supply throughout the body. CRT is a treatment for heart failure that uses an implantable device that sends mild electrical pulses to the ventricles to improve the heart’s pumping efficiency and increase blood flow to the body. By improving blood flow, CRT may help to reduce heart failure symptoms, improve quality of life and reduce mortality. CRT is intended to complement standard drug therapy, and dietary and lifestyle modifications.
References
¹Chronic is defined as greater than one day post implant.
About Medtronic
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 27, 2007. Actual results may differ materially from anticipated results.
Contact:
Medtronic, Inc. Catherine Peloquin, 763-526-2494 Public Relations or Jeff Warren, 763-505-2696 Investor Relations
Source: Medtronic, Inc.
