Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery.
The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients at 60 sites in the U.S., Canada and Europe. The trial's design addresses the issue that, despite symptoms and increased mortality for individuals suffering from MR, patients often are undertreated by open-heart mitral valve surgery.
Currently, roughly 15% of patients eligible for the standard-of-care surgery for their primary MR receive such treatment. While the condition may not be diagnosed in certain individuals, some patients may opt against surgery due to prolonged recovery time or fear of possible complications.
“Despite the known risk of untreated severe MR, research shows that nearly half of all patients with symptomatic severe MR are not operated on due to age, co-morbidities and impaired left ventricle, as was found in the Euro Heart Survey (2003) and a similar study by The Lancet (2018), which used data from the Mayo Clinic,” the company told BioWorld MedTech. “And, to note, this undertreatment is not a delayed treatment that eventually occurs, but rather a lifelong absence of surgical treatment.”
The company added that it expects to start enrollment “in coming months.”
"The REPAIR MR trial seeks to evaluate the Mitraclip device in treating a new patient population who currently undergo the standard surgical treatment, but are at moderate surgical risk," said Patrick McCarthy, chief of cardiac surgery, Northwestern Medicine, executive director, Bluhm Cardiovascular Institute and co-principal investigator of the REPAIR MR trial. "This is an important question since approximately 70% of people diagnosed with primary mitral regurgitation aren't treated with open-heart mitral valve surgery today yet are in need of treatment and symptom relief."
"We're pushing the field forward by making clinical investments to examine whether new, minimally invasive treatment options are suitable, or even preferable, to what has been the standard of care," said Neil Moat, chief medical officer of Abbott's structural heart business. "Devices that can be delivered through a minimally invasive method to close or repair a significant structural issue in the heart are in high demand," he added.
Abbott has seen a lot of success with Mitraclip. The system has been commercially available in the U.S. since 2013 and in Europe since 2008, with the company highlighting its impact for patients with both primary and secondary MR who are at high risk for open-heart surgery.
In March 2019, the company won FDA approval for an expanded indication – to repair a leaky mitral valve without open-heart surgery – which was backed by results of the COAPT trial. It marked the first FDA nod for a transcatheter mitral valve intervention therapy that would treat select heart failure patients with clinically significant secondary, or functional, MR.
The Cleveland Clinic also noticed the promise of minimally invasive mitral valve surgery subsequent to the FDA’s move, placing it in the second position on its annual list of innovations. It was noted that an estimated 1 in 10 individuals older than 75 have a defective mitral valve, causing the action of regurgitation.
Pushing the company forward
During its third-quarter earnings call in October, the company highlighted that its structural heart business saw 16% sales growth, led by Mitraclip. Of note, sales of the device rose more than 30% in the quarter, with growth of almost 50% in the U.S. alone. The quarter also saw the company secure the FDA’s nod for its next-generation Mitraclip device.
Looking ahead, William Blair analysts were confident about the device. “Overall, we remain positive on the durability of Mitraclip sales as Abbott makes headway into the large and undertreated MR opportunity (low-single-digit penetration in the U.S. market of 250,000 patients).”
Analysts appear to remain confident about the device’s potential. In a Dec. 31, 2019, note, Cowen’s Joshua Jennings wrote that Mitraclip, combined with Libre, has the potential to contribute more than 800 basis points of growth.
Abbott is scheduled to present at the J.P. Morgan Healthcare Conference tomorrow.