FDA approves Medtronic left-heart cardiac resynchronization lead
The FDA has approved Medtronic’s Attain StarFix OTW (over-the-wire) lead for cardiac resynchronization therapy (CRT).
As the first active fixation left-heart lead (Model 4195) for CRT, Medtronic said its 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, according to the Minneapolis-based company.
Medtronic said the dislodgement rates are supported by a large and long-running left-heart lead clinical study 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 to 8 percent based on several published clinical studies, according to the company.
Stable fixation of the left-heart lead is critical to a successful CRT implantation, Medtronic said.
As the first active fixation left-heart lead (Model 4195) for CRT, Medtronic said its 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, according to the Minneapolis-based company.
Medtronic said the dislodgement rates are supported by a large and long-running left-heart lead clinical study 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 to 8 percent based on several published clinical studies, according to the company.
Stable fixation of the left-heart lead is critical to a successful CRT implantation, Medtronic said.