- Medtronic said it is relaunching its Harmony transcatheter pulmonary valve that offers a minimally invasive alternative to open-heart surgery for treating patients with severe leakage.
- The valve replacement system was granted FDA approval two years ago, but the company recalled the device last year after six reported cases in which the bond holding the capsule at the end of the delivery catheter broke.
- After correcting the problem, Medtronic now has FDA approval to bring the valve back to market, a move that will help speed revenue growth for the company in its fiscal fourth quarter, CFO Karen Parkhill said last week.
The Harmony valve treats severe pulmonary valve regurgitation in the right ventricular outflow tract carrying blood from the heart to the lungs. In patients with the condition, which typically stems from a congenital heart defect, blood leaks backward into the heart.
When the FDA approved the Harmony valve in March 2021, the agency said it fulfilled an unmet clinical need for many patients with congenital heart disease. The device won premarket approval after receiving FDA’s breakthrough designation to expedite its development.
A year later, Medtronic recalled the device due to the risk of the capsule bond breaking and harming patients. One injury was reported in the FDA’s recall notice. The recall affected 665 devices.
In an April 2022 recall notice, Medtronic asked physicians to immediately stop using the Harmony delivery catheter, according to the FDA. Customers were also instructed to pause new clinical cases involving the Harmony system.
In relaunching the Harmony valve, Medtronic said the treatment may help congenital heart disease patients reduce the number of repeat open-heart surgeries needed over a lifetime to address the condition and prevent risks such as right-sided heart failure. The self-expanding valve is implanted via a catheter through a vein in the groin or neck.
The device is now commercially available for use in the U.S. and has received regulatory approval in Japan, Medtronic said.