A Medical Device Daily
Medtronic (Minneapolis) yesterday reported the first clinical implants in the U.S. of the Attain Ability over-the-wire lead (Model 4196), a dual-electrode left ventricular (LV) lead for use in heart failure patients with cardiac resynchronization therapy (CRT) devices.
Medtronic said the lead features an insulation material that it licensed from NASA, enabling the addition of the lead's two electrodes while maintaining a small lead circumference. It said the material has been evaluated for space applications, high-performance engines and caustic environments. It said the Attain Ability lead marks the first time this material has been used in a medical device.
Implantable leads are used to resynchronize the heart's ventricles to help pump blood through the body. Placing a lead in the LV is recognized as the most challenging aspect of implanting CRT devices because anatomic challenges can make it difficult to access and work within the coronary sinus to place a lead in the desired vein of the LV. Medtronic said the Attain Ability lead is designed for optimal tracking over a guidewire, enabling physicians greater ability to deliver the left heart lead in difficult-to-access veins.
Once implanted, two electrodes at the tip of the lead provide physicians with options to tailor delivery of stimulation for each patient.
When FDA-approved, the Attain Ability lead will be the smallest LV lead in the U.S. market, Medtronic said.
The clinical trial will involve up to 200 patients at 25 centers in the U.S. and Canada to determine safety and efficacy. First implants in the U.S. were conducted by Brian Ramza, MD, director of Electrophysiology Laboratory Services at the Mid-America Heart Institute, Saint Luke's Hospital (Kansas City, Missouri), and principal investigator of the trial. First implants in Canada were conducted by Derek Exner, MD, associate professor, Libin Cardiovascular Institute of Alberta.
CRT resynchronizes the contractions of the heart's ventricles by sending telectrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently. CRT defibrillators (CRT-D) also incorporate additional ltherapy to quickly terminate an abnormally fast, life-threatening heart rhythm. Medtronic began the first clinical evaluations of its CRT systems in 1997.