Medtronic is announcing that the company received FDA approval to market the firm’s Attain StarFix left-heart cardiac resynchronization lead. Having received EU approval two years ago, the lead is designed to prevent its displacement post implantation.
From the press release:
As the first-ever active fixation left-heart lead for cardiac resynchronization therapy (CRT), the 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. 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. Traditional passive fixation left-heart leads, where there is no active mechanism to fix the lead in place, show average dislodgement rates of 2-8 percent based on several published clinical studies.
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. 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.
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 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 to 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, 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™ portfolio.
Press release: Medtronic Receives FDA Approval of Industry’s First Active Fixation Left-Heart Cardiac Resynchronization Lead …
Medtronic video showing the mechanism of lead placement (Windows Media)…