FDA Clears Thin Body Medtronic Left-Heart Lead for CRT Devices

 

May 6, 2009

May 6, 2009 - Medtronic Inc. today said the FDA approval and availability of the Attain Ability left‐heart lead (Model 4196) for use with cardiac resynchronization therapy (CRT) devices for heart failure patients.

Attain Ability reportedly has the thinnest lead body of any left‐heart lead currently available, providing physicians with a tool to deliver therapy directly to hard‐to‐reach areas of the heart. Attain Ability incorporates insulation material developed by the NASA Langley Research Center that was previously evaluated for space applications, high‐performance engines and harsh environments. This application marks the first time a NASA‐developed material has been used in this kind of implantable medical device, Medtronic said.

Navigating a lead through the intricate curves of the heart’s anatomy to place the lead in the ideal location on the left ventricle is recognized by physicians as the most challenging aspect of implanting CRT devices. The compact, flexible design afforded by the NASA insulation material makes this the thinnest left‐heart lead body on the market. Medtronic said its design allows physicians to choose between different sites in order to deliver optimal therapy. Additionally, Attain Ability can be delivered by an inner catheter, the Attain Select II. This feature helps physicians place the lead directly in difficult‐to‐reach areas of the heart.

A clinical study involving 190 patients at 25 centers in the U.S. and Canada showed physicians were successful in placing the Attain Ability lead 96.4 percent of the time.

“The unique design of the Attain Ability lead provides clinicians with a greater degree of flexibility in left ventricular lead placement,” said Brian Ramza, M.D., Ph.D., director of electrophysiology laboratory services at the Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, Mo., and principal investigator of the Attain Ability clinical trial. “The lead provides the flexibility of multi‐site pacing from small veins because of its design, therefore, truly having the potential to improve outcomes for patients with unique needs.”

In addition to the U.S., the Attain Ability lead is available in Europe, Japan, Canada, and Australia. The lead is compatible with the Attain family of exclusive delivery tools including the Attain Select II, the Attain Hybrid Guide Wires and Attain Command, the newest family of left‐heart lead delivery catheters now available in the U.S. and Canada. As part of Medtronic’s fully integrated CRT system, the entire Attain portfolio, including the Attain StarFix left‐heart lead, can be used with Medtronic’s Vision 3D portfolio of wireless CRT‐Ds.

For more information: www.medtronic.com