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.