MINNEAPOLIS (Sept. 2)—Medtronic Inc. has received U.S Food and Drug Administration approval for its Attain 4194 Bipolar over-the-wire left-heart lead that uses a silicone tip seal.
The new steroid-eluting lead, used with cardiac resynchronization systems, has an angled shape and can be inserted using either a guidewire or a stylet delivery method, a company spokesman said.
It's the fourth generation of left-heart leads—which are thin, insulated wires that connect an implantable device to a patient's heart—developed for use with the Medtronic InSync family of cardiac resynchronization therapy pacemaker and defibrillator systems.
The Attain 4194 lead expands the Minneapolis-based firm's left-heart product range to include a 6.2 French lead body for improved stability in larger vein sizes. The previously released Attain 4193 lead is the smallest offering on the market, the company said.