Feature | December 17, 2014

FDA Approves Two New Medtronic Resynchronization Therapy Quadripolar Leads

Additions to Attain Performa line designed to accommodate varying vessel sizes and curvatures

Medtronic, Attain Performa, quadripolar leads

December 17, 2014 – Medtronic Inc. announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of two additional Attain Performa left ventricular (LV) quadripolar leads. Both devices 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 implant success rate of 97.6 percent. The study also indicated a low complication rate and low, stable pacing capture thresholds (PCTs) through six months for all pacing polarities.

“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., FACC, FHRS., 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. 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.

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

For more information: www.medtronic.com

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