Medtronic Receives FDA Approval for Attain Performa® Quadripolar Lead and Viva® Quad CRT-Ds in United States

New System Helps Physicians Deliver Cardiac Resynchronization Therapy Optimally and Efficiently to Heart Failure Patients

MINNEAPOLIS - Medtronic, Inc. today announced it has received United States Food and Drug Administration (FDA) approval for the Attain Performa® Model 4298 quadripolar lead, and the Viva® Quad XT and Viva® Quad S cardiac resynchronization therapy defibrillators (CRT-D). The quadripolar lead and devices will be broadly available to physicians in mid-September.

With 16 pacing configurations and shorter spacing between the two center electrodes, the Attain Performa Model 4298 left-heart lead provides additional options for physicians to treat different patient anatomies. The new quadripolar lead reduces the incidence of phrenic nerve stimulation (PNS)¹, a potential side effect that results in muscle twitching, hiccups or shortness of breath. The Viva Quad XT device is equipped with the proprietary AdaptivCRT feature, which preserves normal heart rhythms and automatically adjusts to patients' needs to customize therapy. The system includes VectorExpress(TM) technology, which reduces lead programming time to two minutes² by providing physicians with clinically actionable information to help them select optimal pacing configurations for each patient.

Quadripolar leads (leads with four electrodes) help physicians optimize cardiac resynchronization therapy delivery. The Attain Performa lead addresses the clinical challenges that can compromise lead position, offering implanting physicians more options to maintain lead position and optimize CRT therapy³. The Model 4298 lead has a canted shape, and steroid on all four electrodes for lower pacing thresholds^4,5.

"Compared to conventional leads, the additional pacing configurations offered by this system provide implanting physicians more options to optimize CRT delivery, which results in better patient care. Likewise, the narrow-spaced bipole helps avoid phrenic nerve capture," said George H. Crossley, M.D., F.A.C.C., F.H.R.S., associate professor, Vanderbilt Heart and Vascular Institute, in Nashville, Tenn.

About the AdaptivCRT Algorithm
The AdaptivCRT algorithm is the first significant advance to improve patient response rates to CRT since the advent of the therapy more than 10 years ago. The benefits of the algorithm were demonstrated in the Adaptive CRT Trial, a prospective, multicenter, randomized, double-blind clinical trial. Key findings from the original trial, sub-analyses and economic models:

•For patients with normal AV conduction, AdaptivCRT showed an increase in CRT response rate of 12 percent⁶ at six months
•Patients with AdaptivCRT demonstrated a 21 percent reduction in heart failure hospitalizations⁷ as compared to historical CRT trials
•Patients with the AdaptivCRT technology demonstrated a 46 percent reduced risk of AF⁸, and a 61 percent lower risk of AF-related problems⁹
•AdaptivCRT demonstrated a reduction in 30-day hospital readmissions for heart failure of 47 percent¹⁰

"Medtronic continues to advance the care of heart failure patients, as it has since it first commercialized cardiac resynchronization therapy in the U.S. With the previously available AdaptivCRT algorithm, and now the new Attain Performa canted lead and Viva Quad devices, Medtronic is delivering a top-notch system for patients with heart failure," said David Steinhaus, M.D., vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm and Heart Failure Management business at Medtronic.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

¹ Biffi et al. Effort of Bipolar Electrode Spacing on Phrenic Nerve Stimulation and Left Ventricular Pacing Thresholds: An Acute Canine Study. Circulation Arrhythmia and Electrophysiology. 2012.
² Demmer, W. VectorExpress Performance Results. Medtronic data on file. January 2013.
³ Medtronic data on file.
⁴ Lunati MG, Gasparini M, Landolina M, et al. Long-Term Effect of Steroid Elution on the Electrical Performance of Coronary Sinus Leads for Cardiac Resynchronization Therapy. Presented at HRS 2012 (AB10-05).
⁵ Lin A, Schotzko E, Foerster L, et al. Does steroid eluting proximal electrodes in left ventricular coronary sinus quadripolar leads improve chronic pacing thresholds. Presented at EHRA EUROPACE 2013 Congress (P1216).
⁶ Birnie D, Lemke B, Aonuma K, et al. Clinical outcomes with synchronized left ventricular pacing: Analysis of the adaptive CRT trial. Heart Rhythm. September 2013;10(9):1368-1374.
⁷ Tarab AD, Dougher CE, Rogers TB, et al. Budget impact of selecting cardiac resynchronization therapy (CRT) devices with adaptive ("aCRT") programming algorithms under the United States Medicare Payment Setting. Value in Health. November 2012;15(7):A349.
⁸ Martin D, et al. Can Adaptive Cardiac Resynchronization Therapy Reduce Atrial Fibrillation Risk? Circulation. 2013;128(22S):A17740.
⁹ Lemke B, et al. Atrial Fibrillation Resource Use with an Adaptive Device Algorithm. June 2014, Cardiostim, Nice, France. 
¹⁰ Starling RC, et al. Impact of Novel Adaptive Optimization Algorithms on 30-day Readmissions: Evidence from the Adaptive CRT Trial. Heart Rhythm 2014;11(5)(suppl):S155

Source: Medtronic, Inc.