Dive Brief:
- FDA has approved the third-generation version of Abbott Laboratories’ MitraClip device, a less invasive alternative to open-heart surgery for patients with leaking mitral valves.
- The company said said the valve repair device has been improved to be easier to position during procedures, and a second clip size lets doctors treat more patients with complex anatomies.
- The device treats mitral regurgitation, which affects one in 10 adults over the age of 75, according to Abbott.
Dive Insight:
Less-invasive mitral valve treatments are the next frontier for heart valve technology now that transcatheter aortic valve replacement (TAVR) systems are rapidly taking market share from surgical valves. Abbott’s MitraClip is the only FDA-approved transcatheter mitral valve repair option for patients deemed ineligible for open-heart surgery, according to the company.
The first version of the MitraClip was approved for use in the United States in 2013. Before the MitraClip, people with mitral regurgitation who were not good candidates for surgery received medication that managed symptoms of the disease but did not stop its progression.
Mitral regurgitation occurs when the valve does not close properly to prevent backflow. It can cause extreme fatigue and shortness of breath and increases the risk of stroke, heart failure and death.
"Physicians rely on MitraClip as an alternative to surgery for patients who aren't surgical candidates and may need treatment to relieve their symptoms or to survive," said Francesco Maisano in a prepared statement, professor at UniversitätsSpital Zürich, Switzerland, and an early adopter of the technology for patients.
In the MitraClip procedure, a surgeon places a catheter into the femoral vein in the leg and threads it through to the heart. Once the catheter is inside the heart's left atrium, the doctor moves the clip through the catheter and positions it above the leak in the mitral valve. The clip grasps both leaflets of the valve to help them close better.
Artificial heart valve pioneer Edwards LifeSciences is developing treatments for mitral regurgitation that would compete with Abbott’s MitraClip. Edwards acquired one minimally invasive repair technology through the purchase last year of privately held Harpoon Medical.
The MitraClip device repairs, rather than replaces, a patient’s mitral valve. Edwards also is pursuing transcatheter mitral valve replacement devices in its pipeline, including a version of its leading Sapien 3 transcatheter aortic valve replacement (TAVR) system.
TAVR has been a highly successful market for Edwards as well as Medtronic, which sells the CoreValve system in the United States. Abbott is working on a transcatheter aortic valve implant called Portico, which it gained in its 2017 acquisition of St. Jude Medical.
