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Medtronic’s Attain StarFix OTW (over-the-wire) lead receives FDA approval

Medtronic : 18 June, 2008  (New Product)
Medtronic has received US Food and Drug Administration approval for the Medtronic Attain StarFix OTW (over-the-wire) lead (Model 4195) which is the first-ever active fixation left-heart lead for cardiac resynchronization therapy (CRT).
The Attain StarFix lead has demonstrated a zero percent chronic dislodgement rate.

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 two to eight 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 MD, clinical cardiac electrophysiologist, St Paul Heart Clinic, St Paul, Minnesota. “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 10cm lengths. The Attain StarFix’s 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. The lead 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 clinical options that are built on our industry leading pacing and ICD exclusives.
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