St. Jude Medical Announces IDE Approval And First Implant Of The QuickSite 1056T Bipolar CRT Lead

St. Jude Medical, Inc. (NYSE:STJ) announced today that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) authorizing enrollment in the fourth phase of the RHYTHM ICD Study, which is evaluating the QuickSite(R) 1056T bipolar left-heart pacing lead, the next advance in the QuickSite(R) family of left-heart leads to be introduced for cardiac resynchronization therapy (CRT).

The first implants of the lead were performed last week by Dr. Stephen J. Ackerman at St. Elizabeth Regional Medical Center in Lincoln, Nebraska, and Dr. James H. Baker II at St. Thomas Hospital in Nashville, Tennessee.

"The lead handled well," said Dr. Ackerman, about the QuickSite(R) 1056T lead. "Multipolar leads have an important role to play in the future of biventricular pacing and this is an excellent start." Dr. Ackerman implanted the lead along with the Epic(TM) HF CRT-D.

"The smooth, controlled tracking of the QuickSite(R) 1056T lead and its steerable distal tip makes it easy to maneuver throughout the coronary venous systems," said Dr. Baker, who implanted the lead along with the Atlas(R)+ HF CRT-D. "Fixation and thresholds were excellent."

"This is the world's first CRT lead to offer physicians the advantages of bipolar sensing and pacing combined with a composite body for superior handling, our unique S-shaped distal tip for outstanding stability, and a choice of stylet or over-the-wire approach to optimize placement," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business.

The St. Jude Medical QuickSite(R) 1056T bipolar lead, which at 5.5 French is as small in diameter as the previously approved QuickSite(R) 1056K unipolar lead, is specifically designed for placement in the coronary sinus to enable left-ventricular pacing in cardiac resynchronization applications. The lead incorporates important advances, including:

-- A polyurethane body that transitions to a distal silicone 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
-- Grooved, circumferential tip electrodes designed to enhance stability and thresholds.

The QuickSite(R) 1056T lead builds upon the proven success of the QuickSite(R) 1056K lead, which demonstrated a lead implant success rate of 94.4% with a mean chronic pacing capture threshold of 1.6 +/- 1.4 V. The rate of QuickSite(R) cases with no lead related complications was 96.1% with only one reported lead dislodgement (0.65%).(1)

The QuickSite(R) 1056T lead is designed for use with the St. Jude Medical Epic(TM) HF CRT-D, the world's smallest high-voltage cardiac resynchronization 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 to the body. About 5 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.