Medtronic Left-Heart Lead Okayed by FDA
by Lynn Shapiro
, Writer | May 11, 2009
Left-Heart Lead okayed
Medtronic said FDA has okayed its Attain Ability left-heart lead (Model 4196) for use with cardiac resynchronization therapy (CRT) devices for heart failure patients. The company said the device is currently available to physicians.
In CRT, a stopwatch-sized device is implanted into the chest and connected by leads to the heart's left and right ventricles. Through electrical impulses, the device resynchronizes heartbeats, allowing blood to be pumped more effectively through the body.
According to the company, Attain Ability 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 NASA Langley Research Center that was previously evaluated for space applications, high-performance engines and harsh environments. The company said that this application marks the first time a NASA-developed material has been used in this kind of implantable medical device.
"Attain Ability is the latest innovation in our long-term strategy to provide physicians with a broad portfolio of leads and delivery systems to meet the unique needs of their patients," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "We're proud to partner with NASA, another innovation leader, to provide physicians with a unique, technology-based solution to assist physicians with optimal lead placement in heart failure patients."
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 design afforded by the NASA insulation material makes this the thinnest left-heart lead body on the market. 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 United States 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."