WASHINGTON -- The FDA has granted premarket approval to a second left ventricular assist system (HeartMate II).
The device can now be used as destination cardiac support for patients with advanced-stage heart failure who are ineligible for transplantation. It was previously approved as an interim device for those awaiting transplantation.
The approval was based on data from a two-year cohort study of 200, which randomized patients to the HeartMate II or the HeartMate XVE, the only other device approved for destination therapy, on a two-to-one basis, according to a statement from the device manufacturer Thoratec.
Endpoints included survival at two years, free of debilitating stroke, and reoperation to repair or replace the device. The new device showed a 58% versus 24% two-year survival rate. Patients also experienced shorter hospital stays, lower rates of rehospitalization, and fewer reoperations annually.
Patients with the HeartMate II noted an 80% increase in quality of life based on a 0% baseline, the release said.
The device showed a lower rate of infection, renal failure, right heart and respiratory failure, and cardiovascular arrhythmia than its predecessor.
As part of the premarket approval, Thoratec must complete a postmarket study and measure adverse effects, functional status, and quality-of-life data.
The company also agreed to a second study to gather data on the relationship between bleeding, thrombosis, von Willebrand syndrome, and anticoagulation in left ventricular assist system patients.
"What this approval does do for the field of engineered solutions to healthcare problems is perhaps the most important aspect of this outcome. Innovation and improvements in technology continue to be made, and I am convinced that even better designs are on the horizon," Robert L. Kormos, MD, director of the Artificial Heart Program at McGowan Institute for Regenerative Medicine, said.
The small size of the device allows it to be implanted in smaller patients, including many women.
The device originally received premarket approval as the second bridge-to-transplantation device, after the HeartMate XVE, in 2008.
Thoratec is located in Pleasanton, Ca.