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St Jude Medical’s QuickFlex family of left-heart leads receive key approvals

St Jude Medical : 23 January, 2008  (New Product)
St Jude Medical’s QuickFlex family of left-heart leads to treat heart failure patients has received the US Food and Drug Administration (FDA) and European CE Mark approval.
The QuickFlex leads, used in CRT (cardiac resynchronisation therapy), feature shorter tip and ring electrodes (used to conduct energy), reducing the length of the lead's rigid portions. The concept behind the shorter electrodes is that it may help the lead through bends in the heart's venous system that characterise the left side of the heart. This could enable physicians to better manoeuvre the lead to the optimal position for therapy.

'The QuickFlex lead is flexible and manoeuvrable,' said John Rogers, MD, from Scripps Clinic in La Jolla, California, USA. 'When working with this lead, I am able to smoothly route it through the venous system to my target location, even through difficult anatomy.'

The QuickFlex lead models also include an S-shaped curve that helps provide stability inside the vein once the lead is placed in the desired location inside the heart. The QuickFlex lead models are available with two different sized S-curves, offering physicians options for patients with varying venous anatomies. The smaller S-shaped curve was evaluated in the company's 1056T QuickSite lead clinical study and demonstrated a high Implant success rate and low dislodgement rate.

The QuickFlex lead joins St Jude Medical's Promote RF CRT-D (cardiac resynchronisation defibrillator), which was launched in November 2007 to treat patients with heart failure using wireless radiofrequency (RF) telemetry, enabling secure, remote communication between the implanted device and the programmer in a clinician's office or hospital. Promote also allows physicians to electronically reconfigure left-ventricular (LV) leads - such as the QuickFlex lead - to help optimise the pacing performance of the device without the need to physically reposition the lead.

'For heart failure patients to receive effective CRT therapy, physicians must be able to effectively navigate the LV lead through a venous system that often twists and turns, in many cases severely, to deliver the electrodes to the best location for stimulation,' said Eric S Fain, president of St Jude Medical's Cardiac Rhythm Management Division. 'The QuickFlex lead offers physicians a good balance of flexibility and stability for effective lead placement.'

The QuickFlex leads are designed for use with St Jude Medical's heart failure devices, including the Promote, Epic II HF and Atlas II HF families of CRT-Ds (CRT defibrillators), and the Frontier II CRT-P, the world's smallest and longest-lasting CRT pacemaker.
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