Abbott Faces Competition From Heart Valve Device Cleared by FDA

“We finally have another option for a less invasive approach for repairing patients’ degenerative mitral valve disease,” said Dr. Scott Lim, a cardiologist at the University of Virginia Health System in Charlottesville, Va., and an investigator in the study. He has received research grants from Abbott and Edwards.

Mitral regurgitation is a condition in which a valve connecting two chambers of the heart doesn’t fully close, allowing blood to leak backward in the valve and impairing blood flow. The condition can cause shortness of breath and fatigue, and severe cases can lead to heart-rhythm disorders or heart failure if not treated.

The risk of moderate or severe mitral regurgitation increases with age, and it is found in nearly 10% of all people 75 and older. For many years, the primary treatment for severe mitral-valve cases has been open-heart surgery to repair or replace the damaged valve.

Such surgery is risky for some patients, including the elderly or those with other conditions such as diabetes. In recent years, as an alternative to surgery, doctors have turned to valve-repair devices that can be delivered less invasively, inserted by catheter through a vein in or near the groin.

Abbott, of Abbott Park, Ill., has dominated the market for mitral-valve repair and is projected to book nearly $1 billion in global sales of MitraClip and another clip device this year, Wells Fargo analysts estimate. They predict the total market for such devices will reach $2.8 billion by 2026, with Edwards’s market share rising to about 44% from 13% this year.

Edwards, of Irvine, Calif., is better known in cardiology as the leading seller of a different type of heart-valve device, known as transcatheter aortic valve replacement, or TAVR.

The company is trying to diversify beyond TAVR, and several years ago developed the Pascal mitral-valve system. It was approved by European health regulators in 2019.

The results of the new Edwards-funded study of Pascal were presented Saturday at the Cardiovascular Research Foundation’s medical conference in Boston and published online in the Journal of the American College of Cardiology.

The results come from an interim analysis of 180 adults in the U.S., Canada and Europe who received either Pascal or MitraClip between 2018 and 2021. Before treatment, they had moderate to severe mitral regurgitation and weren’t suitable candidates for surgery because of the risk of complications.

The study found comparable improvement from Pascal and MitraClip. Six months after mitral-valve repair, about 97.7% of the patients who had received Pascal had mild to moderate mitral regurgitation, as did 98.1% of those receiving MitraClip. This met the study’s goal of demonstrating that Pascal was “noninferior,” or comparable to MitraClip.

Pascal appeared to show an advantage in its ability to reduce patients’ mitral regurgitation to a mild level. Some 83.7% of patients with Pascal had mild disease six months after the procedure, compared with 71.2% of MitraClip patients.

The study compared major adverse events in patients after procedures, including cardiovascular deaths, strokes, heart attacks and other complications. About 3.4% of patients receiving Pascal had experienced one of these within 30 days after the procedure, compared with 4.8% of the MitraClip patients.

The study is continuing, and patients will be followed for several years.

An Abbott spokesman said MitraClip is the leading, proven option for mitral-regurgitation patients and is backed by almost two decades of clinical data. The company said the product has been used in more than 150,000 people globally.

Earlier this month the FDA alerted doctors about a potential clip-lock malfunction with Abbott’s MitraClip delivery systems. The FDA said the malfunctions could reduce the effectiveness of the MitraClip and require patients to undergo additional treatments, though most reported malfunctions haven’t caused problems. Abbott said in a notice to customers that it has identified the cause and is updating its manufacturing process to address the problem.

Write to Peter Loftus at [email protected]

“We finally have another option for a less invasive approach for repairing patients’ degenerative mitral valve disease,” said Dr. Scott Lim, a cardiologist at the University of Virginia Health System in Charlottesville, Va., and an investigator in the study. He has received research grants from Abbott and Edwards.

Mitral regurgitation is a condition in which a valve connecting two chambers of the heart doesn’t fully close, allowing blood to leak backward in the valve and impairing blood flow. The condition can cause shortness of breath and fatigue, and severe cases can lead to heart-rhythm disorders or heart failure if not treated.

The risk of moderate or severe mitral regurgitation increases with age, and it is found in nearly 10% of all people 75 and older. For many years, the primary treatment for severe mitral-valve cases has been open-heart surgery to repair or replace the damaged valve.

Such surgery is risky for some patients, including the elderly or those with other conditions such as diabetes. In recent years, as an alternative to surgery, doctors have turned to valve-repair devices that can be delivered less invasively, inserted by catheter through a vein in or near the groin.

Abbott, of Abbott Park, Ill., has dominated the market for mitral-valve repair and is projected to book nearly $1 billion in global sales of MitraClip and another clip device this year, Wells Fargo analysts estimate. They predict the total market for such devices will reach $2.8 billion by 2026, with Edwards’s market share rising to about 44% from 13% this year.

Edwards, of Irvine, Calif., is better known in cardiology as the leading seller of a different type of heart-valve device, known as transcatheter aortic valve replacement, or TAVR.

The company is trying to diversify beyond TAVR, and several years ago developed the Pascal mitral-valve system. It was approved by European health regulators in 2019.

The results of the new Edwards-funded study of Pascal were presented Saturday at the Cardiovascular Research Foundation’s medical conference in Boston and published online in the Journal of the American College of Cardiology.

The results come from an interim analysis of 180 adults in the U.S., Canada and Europe who received either Pascal or MitraClip between 2018 and 2021. Before treatment, they had moderate to severe mitral regurgitation and weren’t suitable candidates for surgery because of the risk of complications.

The study found comparable improvement from Pascal and MitraClip. Six months after mitral-valve repair, about 97.7% of the patients who had received Pascal had mild to moderate mitral regurgitation, as did 98.1% of those receiving MitraClip. This met the study’s goal of demonstrating that Pascal was “noninferior,” or comparable to MitraClip.

Pascal appeared to show an advantage in its ability to reduce patients’ mitral regurgitation to a mild level. Some 83.7% of patients with Pascal had mild disease six months after the procedure, compared with 71.2% of MitraClip patients.

The study compared major adverse events in patients after procedures, including cardiovascular deaths, strokes, heart attacks and other complications. About 3.4% of patients receiving Pascal had experienced one of these within 30 days after the procedure, compared with 4.8% of the MitraClip patients.

The study is continuing, and patients will be followed for several years.

An Abbott spokesman said MitraClip is the leading, proven option for mitral-regurgitation patients and is backed by almost two decades of clinical data. The company said the product has been used in more than 150,000 people globally.

Earlier this month the FDA alerted doctors about a potential clip-lock malfunction with Abbott’s MitraClip delivery systems. The FDA said the malfunctions could reduce the effectiveness of the MitraClip and require patients to undergo additional treatments, though most reported malfunctions haven’t caused problems. Abbott said in a notice to customers that it has identified the cause and is updating its manufacturing process to address the problem.

Write to Peter Loftus at [email protected]