FDA OKs MitraClip for inoperable patients
Candace Stuart | October 25, 2013 | Cardiovascular Business | Structural Heart Disease

The FDA approved the MitraClip as a treatment for patients with mitral regurgitation who are considered too high risk for mitral valve surgery.

The MitraClip is a minimally invasive device that is catheter based, making it a potentially suitable treatment for patients with significant symptomatic mitral regurgitation who may be too sick or frail to undergo open heart surgery. The device is delivered transfemorally to the heart and then implanted.   

The FDA’s Circulatory System Devices Panel voted 5-3 in favor of Abbott’s MitraClip clip delivery system on March 20. Their recommendation was based on results from three trials: EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), EVEREST II High Risk and REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip System), which evaluated MitraClip therapy in high surgical risk patients with significant mitral regurgitation.

The MitraClip device received CE Mark in 2008 and is commercially available in Europe and other international markets. Abbott Park, Ill.-based Abbott announced the U.S. launch of the MitraClip in conjunction with the FDA’s approval. 

Candace Stuart, Contributor

Related Content

Cardiologists make history, perform first-ever transcaval TAVR for pure aortic regurgitation
Q&A: Interventional cardiologist details key breakthroughs in tricuspid valve replacement and repair
PHOTO GALLERY: Highlights from ACC.24 in Atlanta
Cardiologist highlights key takeaways from SMART trial, which looked at TAVR in small annulus patients
TAVR, SAVR both linked to low reintervention rates after five years
ACC.24: TAVR linked to lower 1-year mortality, stroke rates than SAVR in low-risk patients

Around the web

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Radiology Business
Philips launches new AI-enabled CT scanner aimed at cardiology at ECR 2024

Philips introduced a new CT system at ECR aimed at the rapidly growing cardiac CT market, incorporating numerous AI features to optimize workflow and image quality.

Design by Adaptive Theme
Trimed Popup
Trimed Popup