Regulatory News

MitraClip Now Indicated in COAPT Population

Gregg W. Stone
Gregg W. Stone

The FDA announced that it has approved a new indication for a transcatheter mitral valve repair device for the treatment of patients with HF and moderate-to-severe or severe mitral regurgitation.

The approval of this indication for the device (MitraClip, Abbott) was based on results of the COAPT trial, according to an announcement from the FDA. As Cardiology Today’s Intervention previously reported, at 2 years, patients with HF with moderate-to-severe or severe functional mitral regurgitation who had transcatheter mitral valve repair plus optimal medical therapy had reduced risk for HF hospitalization and mortality compared with patients treated with optimal medical therapy alone. Patients treated with the device also had improved exercise tolerance and quality of life.

“We are gratified that the FDA has quickly moved to grant an indication for MitraClip treatment of patients with heart failure and severe secondary mitral regurgitation who remain symptomatic despite guideline-directed medical therapy,” Gregg W. Stone, MD, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Irving Medical Center, told Cardiology Today’s Intervention. “As demonstrated in COAPT, this therapy offers the potential to substantially prolong survival, prevent hospitalizations and improve quality of life for tens of thousands of suffering patients.”

B. Hadley Wilson
B. Hadley Wilson

The device, which was first approved in 2013, was indicated for the reduction of mitral regurgitation in patients with HF symptoms and significant mitral regurgitation that resulted from mitral valve abnormalities and with prohibitive risks for mitral valve surgery.

“Since MitraClip was approved in 2013 for degenerative primary mitral valve regurgitation, this is an important and impactful new treatment indication for secondary moderately severe or worse mitral regurgitation from heart failure,” B. Hadley Wilson, MD, FACC, interventional cardiologist at the Sanger Heart and Vascular Institute at Atrium Health in Charlotte, North Carolina, clinical professor of medicine at UNC School of Medicine and member of the board of trustees for the American College of Medicine, told Cardiology Today’s Intervention.

Currently the device is contraindicated in patients with endocarditis of the mitral valve, are unable to tolerate blood thinners during or after the procedure, rheumatic mitral valve disease or blood clots in the heart or veins leading to it, according to the announcement.

Bram D. Zuckerman
Bram D. Zuckerman

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation who have failed to get symptom relief from other therapies provides an important new treatment option,” Bram D. Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said in the press announcement. “Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure.”

Even though this new indication is a major step for this device, more work needs to be done, experts said.

Michael J. Mack
Michael J. Mack

“Regulatory approval is fine; however, CMS reimbursement is going to be key,” Michael J. Mack, MD, FACC, medical director of cardiovascular surgery at Baylor Health Care System in Dallas, chairman of the Heart Hospital Baylor Plano Research Center in Texas and Cardiology Today’s Intervention Editorial Board Member, said in an interview. “They will likely want to be sure the clinical rollout replicates the COAPT trial results. We may see a heart failure specialist as a gatekeeper to be assured that medical therapy is optimized.” – by Darlene Dobkowski

Disclosures: The COAPT trial was funded by Abbott. Mack was a co-principal investigator for the COAPT trial and reports he had travel expenses paid for trial committee meetings by Abbott. Stone reports his employer, Columbia University, receives royalties from Abbott for sales of the MitraClip. Wilson reports no relevant financial disclosures. Zuckerman is an employee of the FDA.

Gregg W. Stone
Gregg W. Stone

The FDA announced that it has approved a new indication for a transcatheter mitral valve repair device for the treatment of patients with HF and moderate-to-severe or severe mitral regurgitation.

The approval of this indication for the device (MitraClip, Abbott) was based on results of the COAPT trial, according to an announcement from the FDA. As Cardiology Today’s Intervention previously reported, at 2 years, patients with HF with moderate-to-severe or severe functional mitral regurgitation who had transcatheter mitral valve repair plus optimal medical therapy had reduced risk for HF hospitalization and mortality compared with patients treated with optimal medical therapy alone. Patients treated with the device also had improved exercise tolerance and quality of life.

“We are gratified that the FDA has quickly moved to grant an indication for MitraClip treatment of patients with heart failure and severe secondary mitral regurgitation who remain symptomatic despite guideline-directed medical therapy,” Gregg W. Stone, MD, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Irving Medical Center, told Cardiology Today’s Intervention. “As demonstrated in COAPT, this therapy offers the potential to substantially prolong survival, prevent hospitalizations and improve quality of life for tens of thousands of suffering patients.”

B. Hadley Wilson
B. Hadley Wilson

The device, which was first approved in 2013, was indicated for the reduction of mitral regurgitation in patients with HF symptoms and significant mitral regurgitation that resulted from mitral valve abnormalities and with prohibitive risks for mitral valve surgery.

“Since MitraClip was approved in 2013 for degenerative primary mitral valve regurgitation, this is an important and impactful new treatment indication for secondary moderately severe or worse mitral regurgitation from heart failure,” B. Hadley Wilson, MD, FACC, interventional cardiologist at the Sanger Heart and Vascular Institute at Atrium Health in Charlotte, North Carolina, clinical professor of medicine at UNC School of Medicine and member of the board of trustees for the American College of Medicine, told Cardiology Today’s Intervention.

Currently the device is contraindicated in patients with endocarditis of the mitral valve, are unable to tolerate blood thinners during or after the procedure, rheumatic mitral valve disease or blood clots in the heart or veins leading to it, according to the announcement.

Bram D. Zuckerman
Bram D. Zuckerman

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation who have failed to get symptom relief from other therapies provides an important new treatment option,” Bram D. Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said in the press announcement. “Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure.”

Even though this new indication is a major step for this device, more work needs to be done, experts said.

Michael J. Mack
Michael J. Mack

“Regulatory approval is fine; however, CMS reimbursement is going to be key,” Michael J. Mack, MD, FACC, medical director of cardiovascular surgery at Baylor Health Care System in Dallas, chairman of the Heart Hospital Baylor Plano Research Center in Texas and Cardiology Today’s Intervention Editorial Board Member, said in an interview. “They will likely want to be sure the clinical rollout replicates the COAPT trial results. We may see a heart failure specialist as a gatekeeper to be assured that medical therapy is optimized.” – by Darlene Dobkowski

Disclosures: The COAPT trial was funded by Abbott. Mack was a co-principal investigator for the COAPT trial and reports he had travel expenses paid for trial committee meetings by Abbott. Stone reports his employer, Columbia University, receives royalties from Abbott for sales of the MitraClip. Wilson reports no relevant financial disclosures. Zuckerman is an employee of the FDA.