St. Jude Medical Announces FDA Approval And U.S. Launch Of Bipolar CRT Lead
"The bipolar design and excellent stability of the QuickSite 1056T lead allow physicians to select a biventricular pacing configuration that provides low pacing thresholds while avoiding anodal stimulation," said James H. Baker II, M.D., St. Thomas Hospital in Nashville, Tennessee. "The option of unipolar or bipolar pacing can help reduce phrenic nerve stimulation."
"The St. Jude Medical QuickSite(R) bipolar lead leverages the clinically proven design of the QuickSite unipolar lead, adding the flexibility of bipolar pacing to better manage patients with phrenic nerve stimulation," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Division.
In the RHYTHM ICD/QuickSite(R) Model 1056T lead clinical study, the QuickSite(R) bipolar lead had a freedom from lead-related complications rate of greater than 96%. It is further evidence of the exceptional stability of the QuickSite(R) family of left-heart leads, with a low 1.5% dislodgement rate. Low pacing thresholds, a hallmark of the QuickSite(R) lead family, were evidenced with the QuickSite(R) 1056T lead's 1.5 volt mean bipolar capture threshold at three months. The bipolar version of the lead also showed a high impedance (814 Ohms), which can improve device longevity. There were no diaphragmatic/phrenic nerve stimulation complications at three months.
Important innovations and advances offered by QuickSite(R) leads include:
-- A polyurethane-insulated body that transitions to a distal silicone-insulated tip section designed for optimal pushability, torque transfer and tip flexibility;
-- A steerable, S-shaped distal tip designed to improve maneuverability and anchoring of the lead at distal as well as more proximal locations within the coronary sinus;
-- A choice of either a ball-tipped guiding stylet or a guidewire during the same implant for maximum flexibility in lead placement;
-- A radiopaque suture sleeve that enhances visibility on fluoroscopy without blocking visibility of the underlying coils; and
-- A grooved, circumferential tip electrode designed to enhance stability and thresholds.
The QuickSite(R) 1056T bipolar lead is designed for use with the St. Jude Medical Epic(TM) HF CRT-D (cardiac resynchronization therapy defibrillator), the world's smallest high-voltage cardiac resynchronization therapy device, and the Atlas(R)+ HF CRT-D, the world's highest energy output cardiac resynchronization therapy device, to treat heart failure.
Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood in the body. About five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. The economic burden of heart failure is estimated at $40 billion per year.