Medtronic Inc., the Fridley, Minnesota-based medical device company, announced Thursday that the U.S. Food and Drug Administration approved the Attain Ability Plus and the Attain Ability Straight left-heart leads for use with cardiac resynchronization therapy (CRT) devices.
The two new dual-electrode leads are part of a line of advanced left-heart lead options that fit through the Attain Select II sub-selection catheter delivery system. They are able to navigate a variety of patient vein anatomies to enhance success during the CRT implant procedure.
“With the availability of Attain Ability Plus and Attain Ability Straight, I now have access to a comprehensive family of left-heart leads designed to address the needs of a range of heart failure patients and have a proven track record of successful delivery of CRT,” said Dr. George H. Crossley, with the Saint Thomas Research Institute and Saint Thomas Heart at Baptist Hospital in Nashville, Tennessee, in a statement.
Clinical studies conducted on these leads show that about 94 percent of physicians positively rated the ability to position the Attain Ability Plus lead to the desired cardiac veins, with a one-month, complication-free rate of 98.5 percent. Further, 96.8 percent of physicians positively rated the handling of the Attain Ability Straight and the ability to maneuver it to the appropriate veins, with a low lead-dislodgement rate of 3.2 percent.
