St Jude CRT-D and pacing lead gets FDA clearance

1 December 2011 (Last Updated December 1st, 2011 18:30)

St Jude Medical has received US Food and Drug Administration (FDA) approval for its Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead.

St Jude Medical has received US Food and Drug Administration (FDA) approval for its Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead.

The Quartet lead, used along with the Unify Quadra system, consists of four electrodes spaced over 4.7cm, providing up to ten pacing configurations that helps physicians to place the lead in a stable position.

The Quartet pacing lead is based on the QuickFlex µ lead platform, featuring Optim insulation that integrates the biostability and flexibility of silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability.

The two products enable healthcare providers to effectively manage the needs of patients with heart failure.

Abbott Northwestern Hospital Minneapolis Heart Institute Dr Charles Gornick said the Unify Quadra system helped them to deliver effective CRT therapy by programming different lead configurations rather than surgically repositioning the lead itself.

St. Jude Medical Cardiac Rhythm Management Division president Eric Fain said the new system will redefine the standard of care in resynchronisation therapy for heart failure patients round the globe.