FDA Approves Two New Defibrillator Leads from Medtronic

The U.S. Food and Drug Administration (FDA) has approved two additional Attain Performa left ventricular (LV) quadripolar leads from Medtronic Inc., which can be paired with the the company’s 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, 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, according to data presented by the company.

“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., 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.

“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 Medtronic’s AdaptivCRT algorithm, which is designed to improve 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 therapy^iv (as compared to conventional biventricular therapy) and reduce the risk of atrial fibrillation.

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.

The Attain Performa Quadripolar Lead Clinical Study is a global trial that evaluated the safety and effectiveness of the Attain Performa leads. The study demonstrated a 97.6 percent implant success rate and the PNS complication-free rate was 99.7 percent. Steroid on all four electrodes resulted in low, stable PCTs through six months for all pacing polarities. The study enrolled 1,201 patients indicated for a CRT-D from approximately 130 centers across the world. All implanted patients were followed at one, three, six and every subsequent six months post-implant.

Medtronic Inc. currently is headquartered in Minneapolis, Minn. Through its recent acquisition of Covidien plc, the company will move its financial headquarters to Covidien’s base in Ireland for tax purposes.