Today announced the commercial release outside the United States of another in its family of left-heart leads and delivery systems designed to provide effective options for physicians using cardiac resynchronization therapy to treat heart failure patients.

            The new Medtronic left-heart delivery system includes the Attain Access Model 6218 Left-heart Delivery System and the Marinr™ MCXL Steerable EP Catheter, Model 072402. The system is designed to facilitate rapid coronary sinus cannulation and cardiac vein selection in left-heart lead procedures. Cardiac vein and left ventricular leads are delivered through these systems and connected to implantable devices such as the Medtronic InSync® and InSync® ICD.  The InSync and InSync ICD cardiac resynchronization systems use a pacemaker-like device to stimulate both ventricles, in addition to the upper and lower chambers of the heart, to improve cardiac pumping capability for patients with advanced heart failure.

            The Attain Access 6218 Left-heart Delivery System includes straight, flexible guide catheter sheaths that can be used with a steerable EP catheter such as the Marinr MCXL, or with a fixed-curve EP catheter, to navigate difficult cardiac anatomies often found in heart failure patients. The soft-tip design of its guide catheters may reduce the chances of trauma to delicate cardiac veins, and its longer guide catheter sheaths are designed to facilitate more secure lead placements.

Nearly 22 million people worldwide suffer from heart failure, five million in the United States alone.  U.S. hospitalizations for heart failure total more than 6.5 million days a year, with the cost of treating this disease estimated at between $38 billion and $40 billion annually worldwide.  Up to 15 percent of those with advanced heart failure have heart rhythm abnormalities that can be treated through cardiac resynchronization. Many of these patients have enlarged, rotated hearts with torturous anatomies that make left-heart venous lead placements a challenging task.

To facilitate lead placements in these patients, Medtronic has adopted a portfolio approach to enable physicians to choose the appropriate delivery system to address each patient’s individual anatomical needs. The Attain Access 6218 Left-heart Delivery System, along with the Marinr MCXL Steerable EP Catheter, joins a growing family of  Medtronic left-heart lead products that includes:

·        Attain LV Model 2187 and Attain CS Model 2188, commercially released outside the United States in August 1998 and currently under U. S. clinical investigation in the Medtronic MIRACLE Study;

·        Attain Side-Wire Model 4191, commercially released outside the United States in June, 2000;

·        Attain SD Model 4189, commercially released outside the United States in November 2000, and currently under U. S. clinical investigation in the Medtronic MIRACLE ICD Study;

·        Attain OTW Model 4193, currently under U. S. clinical investigation in the Medtronic InSync III Study; and,

·        Attain LDS Model 6216, commercially released outside the United States in September 1999 and currently under U. S. clinical investigation in the Medtronic MIRACLE, MIRACLE ICD and InSync III Studies.