News | June 16, 2008

Medtronic’s New Left-Heart CRT Lead Gets FDA Clearance

June 17, 2008 - The FDA has cleared Medtronic Attain StarFix OTW (over-the-wire) lead (Model 4195), an active fixation left-heart lead for cardiac resynchronization therapy (CRT).

The Attain StarFix lead, according to the manufacturer, overall, including the acute dislodgements at one day post-implant, has had 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.

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 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 reportedly 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 is designed 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.”

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(tm) 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.

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