
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for another pair of its Attain Performa defibrillator leads, designed for varying vessel sizes and curvatures.
Medtronic said the Attain Performa S-shaped and straight leads are meant for its Viva Quad XT and Viva Quad S CRT-Ds.
"With the 2 new shapes, the Attain Performa quadripolar lead portfolio gives physicians more options than any other CRT-D system available in the United States," heart failure general manager Dr. David Steinhaus said in prepared remarks. "We are committed to driving advancements in CRT, and designed these leads to give physicians tools to customize treatment for their patients.”
“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 non-response to therapy," added Dr. George Crossley of Nashville’s Vanderbilt Heart & Vascular Institute. "Having access to a range of lead shapes that work with 1 CRT-D system gives physicians the ability to help our heart failure patients, even if their cardiac anatomy is challenging."