Technology | September 03, 2008

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

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

According to the manufacturer, the Attain StarFix lead has had a low 0.7 percent dislodgement rate overall, including the acute dislodgements at one day post-implant. 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 5F 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 24F 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.

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