Medtronic, Inc. receives US FDA approval for Attain StarFix® OTW (over-the-wire) lead, a new solution for the accurate placement and stability of the left ventricle (LV) pacing lead in patients undergoing cardiac resynchronization therapy (CRT).
The first-ever active fixation left-heart cardiac resynchronization lead helps improve cardiac disease management by facilitating optimal placement of the lead in patients with varying vein sizes, configurations and positions. Clinical study follow-ups, for up to four years demonstrated that on the whole, there were fewer lead dislodgements (0.7%), including zero percent chronic dislodgement rate, in patients implanted with the active fixation left-heart lead. Several other studies on conventional passive fixation left-heart leads showed 2% to 8% average dislodgement rate.
Medtronic Attain StarFix steroid-eluting unipolar lead includes unique features such as:
• Different sizes available in 78, 88 and 103 cm length and 5-French diameter
• Stable placement in the target location facilitated by three soft, flexible, polyurethane lobes near the lead tip
• Acute repositioning of the lead to up to 24-French diameter (1/4th inch), assisted by the pliable lobes as per the requirement
• Fewer possibilities of dislodgement during catheter withdrawal owing to the secured position of the electrode
• Accurate placement in patients with complicated vein size or configuration
• Compatible with all Medtronic CRT-defibrillators (CRT-D)
• Reduced risks of additional surgeries and consequent surgery-related infections due to fewer dislodgement of left-heart lead.
Cardiac resynchronization therapy (CRT) is used for the treatment of patients with heart failure-induced conduction disturbances and ventricular dyssynchrony. CRT improves cardiac function by re-establishing ventricular activation and contraction. Studies demonstrate that the addition of CRT to the established, optimal medical therapy reduces the all-cause death rate (24%), as well as heart failure hospitalizations (35%) in patients with symptomatic heart failure who have extended QRS duration on electrocardiogram and reduced left ventricular ejection fraction. However, the placement of left ventricular lead is technically difficult and is associated with complications such as lead dislodgement, necessitating additional surgeries which further increase surgery-related risks like infections.
With the FDA approval of the Attain StarFix, physicians will now be able to achieve stable fixation of the left-heart lead in patients undergoing CRT implantation, thereby further enhancing the quality of life.
About Medtronic, Inc. – Based in Minneapolis, Minnesota, Medtronic is a leading provider of medical technology, developing and manufacturing an array of products and therapies for the diagnosis, prevention and monitoring of chronic diseases. The Attain StarFix Lead adds to Medtronic’s existing over-the-wire (OTW) lead portfolio including Attain® Unipolar OTW Lead and Attain® Bipolar OTW Lead. The $13.5 billion company, employing more than 38,000 people, carries out its businesses in over 120 countries.
References
1. Medtronic Receives FDA Approval of Industry’s First Active Fixation Left-Heart Cardiac Resynchronization Lead. News Release. Medtronic, Inc. Last Accessed on June 19, 2008.
2. McAlister F, Ezekowitz J, Wiebe N, et al. Cardiac Resynchronization Therapy for Congestive Heart Failure. Evidence Report/Technology Assessment.106:1-8.
