Medtronic Receives FDA Approval and Launches Two New Cardiac Resynchronization Therapy Quadripolar Leads

Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of two additional Attain Performa® left ventricular (LV) quadripolar leads, which can be paired with the Medtronic Viva® Quad XT and Viva® Quad S cardiac resynchronization therapy defibrillators (CRT-D) to treat patients with heart failure. The newest additions to the Attain Performa lead portfolio, the S-shape and Straight leads, are designed to accommodate patients' varying vessel sizes and curvatures to enhance successful lead placement. Quadripolar leads (leads with four electrodes) help physicians optimize cardiac resynchronization therapy, which uses an implantable device to improve the pumping efficiency of the heart.

FDA approval for the additional quadripolar leads follows the August 2014 approval of the Attain Performa Model 4298 Dual Cant quadripolar lead. All three leads were studied in the multicenter Attain Performa Quadripolar Lead Clinical Study, involving more than 1,200 patients. Results featured at the 2014 American Heart Association Scientific Session demonstrate an excellent implant success rate (97.6 percent), and show that CRT with the Attain Performa family of LV quadripolar leads is associated with a low complication rate, and low, stable pacing capture thresholds (PCTs) through six months for all pacing polarities.i

"While optimal lead positioning has been shown to improve CRT response rates, every patient is different, making lead placement and stability a common challenge that can result in nonresponse to therapy," said George H. Crossley, M.D., F.A.C.C., F.H.R.S., associate professor, Vanderbilt Heart and Vascular Institute in Nashville, Tenn. "Having access to a range of lead shapes that work with one CRT-D system gives physicians the ability to help our heart failure patients, even if their cardiac anatomy is challenging."

The three Attain Performa lead shapes -Dual Cant Model 4298, Straight Model 4398 and S-Shape Model 4598 -were designed to accommodate various anatomies without compromising lead handling or stability. With 16 pacing configurations and shorter spacing between the two center electrodes, these quadripolar leads have been shown to reduce the incidence of phrenic nerve stimulation (PNS), a potential issue associated with CRT therapy that results in muscle twitching, hiccups or shortness of breath.ii Attain Performa leads also include steroid elution on all four electrodes for lower chronic pacing thresholds, which contribute to greater device longevity and reduce the likelihood of PNS.iii

"With the two new shapes, the Attain Performa quadripolar lead portfolio gives physicians more options than any other CRT-D system available in the United States," said David Steinhaus, M.D., vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm and Heart Failure Business at Medtronic. "We are committed to driving advancements in CRT, and designed these leads to give physicians tools to customize treatment for their patients."

All three Attain Performa leads are compatible with the company's newest portfolio of CRT devices, the Viva Quad XT and Viva Quad S CRT-D systems. The Viva Quad XT CRT-D features the Medtronic-exclusive AdaptivCRT® algorithm, which significantly improves heart failure patients' response rate to therapy by preserving normal heart rhythms and automatically adapting to patient needs, creating a customized therapy for each patient. AdaptivCRT is the only algorithm demonstrated to improve heart failure patients' response to the therapyiv (as compared to conventional biventricular therapy) and reduce the risk of atrial fibrillation, or AFv.

The system also includes VectorExpress(TM) technology, an automated in-office test that reduces lead programming time to two minutes,vi and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.