The US Food and Drug Administration (FDA) has given its approval to heart pump HeartMate II, which helps severe heart failure patients who are not acceptable candidates for a transplant, after it was tested at a US hospital.
HeartMate II is a small, lightweight blood pump, which is implanted in a patient’s chest just below the heart.
The device received FDA approval after it was tested at Sharp Memorial Hospital in Kearny Mesa, San Diego, California, US.
If the device fails or changes occur that will affect the pump’s operation it alerts the physician with an alarm sound.
THe FDA’s Center for Devices and Radiological Health director Jeffrey Shuren said because HeartMate II is small in size it gives women and men of a smaller stature access to treatment.
“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” Shuren said.
A clinical study of the device included 200 participants at 38 centres and found 46% of patients with the HeartMate II device were living without any additional surgeries for device replacement or repair after two years, compared with 11% who did not receive the HeartMate II.