Minneapolis, US - Medtronic Inc. has announced that the US Food and Drug Administration (FDA) has approved the Medtronic Attain StarFix OTW (over-the-wire) lead (model 495). As the first-ever active-fixation left-heart lead for cardiac resynchronisation therapy (CRT), the Attain StarFix lead has demonstrated a zero chronic dislodgement rate, the company said.
Medtronic said the Attain Starfix's unique 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 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 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, the company explained.
"This lead helps to ensure successful placement of CRT therapy even in the most difficult cases, which ultimately results in better management of my patients cardiac disease," said Stuart Adler MD, clinical cardiac electrophysiologist, St Paul Heart Clinic, St Paul, Minneapolis.