Feature | March 22, 2013

FDA Advisory Committee Supports MitraClip for Patients With Significant Mitral Regurgitation Who Are Too High Risk for Surgery

Abbot MitraClip

March 22, 2013 —  Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.

Abbott's MitraClip device, which received CE mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.   

"We appreciate the FDA's dedication of time and resources to convene this advisory panel for MitraClip and for its review of this new and novel technology for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "

On the separate question of whether there is reasonable assurance the device is safe, the panel voted Yes: 8, No: 0. On the question of whether there is reasonable assurance of efficacy, the panel voted Yes: 4, No: 5. The FDA will take into account the panel's advice in making its decision on whether to approve the MitraClip for the treatment of significant MR in the United States. The company expects a decision later this year.

The committee's recommendation followed a review of data from a large and growing body of clinical evidence (EVEREST II, EVEREST II High Risk and REALISM) in which the MitraClip therapy demonstrated positive and consistent results for high surgical risk patients suffering from the debilitating symptoms of significant MR, including a safe procedure, reduction in MR, reverse left ventricular remodeling, improvement in heart failure symptoms, improvements in quality of lifeand reduced rates of re-hospitalization.

For more information: www.abbott.com

Reference:

1. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. “Burden of valvular heart diseases: a population-based study.” Lancet. 2006 Sept. 16; 368(9540):1005-11.

Related Content

Raj Makkar, M.D., led a multicenter national study comparing outcomes for minimally invasive heart valve replacement to open-heart surgery. Photo by Cedars-Sinai. TAVR performs as well as surgery for aortic valve replacement.

Raj Makkar, M.D., led a multicenter national study comparing outcomes for minimally invasive TAVR heart valve replacement to open-heart surgery. The study showed the two methods have similar outcomes. Photo by Cedars-Sinai.

News | Heart Valve Technology | January 31, 2020
January 31, 2020 — A new study from the Sm...
Abbott Tendyne TMVR, TMVI system received European CE mark clearance in January 2020. The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system uses an anchor attached to the apex of the heart with a whether line attached to the valve. This helps to keep the valve anchored in the mitral annulus and prevent embolization. This anchor system was used because, unlike the aortic valve, the mitral valve has a very thin landing zone to secure the valve. Prevents LVOT obstruction.

The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system uses an anchor attached to the apex of the heart with a whether line attached to the valve. This helps to keep the valve anchored in the mitral annulus and prevent embolization. This anchor system was used because, unlike the aortic valve, the mitral valve has a very thin landing zone to secure the valve. The design also eliminated any hardware hanging or folding into the left ventricle, which could cause left ventricular outflow track (LVOT) obstruction, which can prevent blood flow through the aortic valve and to the rest of the body.

Feature | Heart Valve Technology | January 30, 2020
January 30, 2020 — The Abbott Tendyne Transcatheter Mitral Valve Implantation (TMVI) system received European CE mark
This is the latest version of the MitraClip, the G4, which allows each side of the clip to be opened and closed independently to offer more flexibility when capturing the valve leaflets. The device is being used in the REPAIR MR clinical trial.

This is the latest version of the MitraClip, the G4, which allows each side of the clip to be opened and closed independently to offer more flexibility when capturing the valve leaflets. The device is being used in the REPAIR MR clinical trial. 

News | Heart Valve Technology | January 13, 2020
January 13, 2020 — The U.S.
The Wyss Translational Center in Zurich, Switzerland has developed the LifeMatrix platform to engineer tissues that can be implanted in patients and will grow with them. This technology is being developed for heart valves in younger patients to eliminate the need for repeat surgeries to implant larger prosthetic heart valves as the patient grows.

The Wyss Translational Center in Zurich, Switzerland has developed the LifeMatrix platform to engineer tissues that can be implanted in patients and will grow with them. This technology is being developed for heart valves in younger patients to eliminate the need for repeat surgeries to implant larger prosthetic heart valves as the patient grows.

 

News | Heart Valve Technology | December 26, 2019
While transcatheter heart valve replacement and repair devices are growing in popularity due to their delivery and qu
A sample of the transcatheter mitral valve replacement (TMVR) devices in development or clinical trials.

A sample of the transcatheter mitral valve replacement (TMVR) devices in development or clinical trials.

Feature | Heart Valve Technology | November 27, 2019 | Saipriya Iyer
The overwhelming success story for transcatheter aortic valve replacement (TAVR) moving from a science project to bec
A key slide from the TRILUMINATE study one-year results showing the improvement in tricuspid regurgitation from basement with treatment using the transcatheter TriClip device.

A key slide from the TRILUMINATE study one-year results showing the improvement in tricuspid regurgitation from basement with treatment using the transcatheter TriClip device.

News | Heart Valve Technology | November 26, 2019 | Dave Fornell, Editor
November 26, 2019 — The preliminary one-year results of the TRILUMINATE Pivotal Study for Abbott's TriClip device, a
 Retired National Football League (NFL) star Ed White, the former Chargers guard and four-time Pro Bowler, waited until the FDA approved TAVR for low-risk patients like himself to avoid open-heart surgery.

Retired National Football League (NFL) star Ed White, the former Chargers guard and four-time Pro Bowler, waited until the FDA approved TAVR for low-risk patients like himself to avoid open-heart surgery.

Feature | Heart Valve Technology | October 29, 2019
October 29, 2019 — When Scripps cardiologists discovered early in 2019 that retired National Football League (NFL) gr
Overlay Init