Dive Brief:

• Abbott announced Monday FDA approved a clinical trial the company hopes will lead to an expansion of MitraClip's indication to include patients with moderate surgical risk. The transcatheter mitral valve repair device, used to treat primary mitral regurgitation (MR), is currently only indicated for patients at a prohibitive risk for surgery. 
• The prospective, randomized clinical trial aims to enroll 500 patients at 60 locations in the United States, Canada and Europe. It seeks to evaluate if MitraClip is effective for moderate-risk patients who would otherwise receive open heart surgery.  
• Abbott's product, which primarily competes with Edward Lifesciences' Pascal system, has been commercially available in the U.S. since 2013 and in Europe since 2008. 

Dive Insight:

Abbott said the clinical investment is an effort to see if a minimally invasive procedure is as effective as open heart surgery and poses an opportunity to expand treatment to a new patient population. Mitral regurgitation, a common life-threatening heart valve disease, occurs when an individual's mitral valve does not close properly, allowing blood to flow backward into the atrium.

"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," said co-principal investigator of the REPAIR MR trial Patrick McCarthy, chief of cardiac surgery at Northwestern Medicine, in a statement.

MitraClip sales increased by more than 30% during Abbott's 2019 third quarter to $176 million, with U.S. growth of 45.7%, compared to the previous year. The company announced in July 2019 FDA approved the MitraClip G4, which added additional device clip sizes and other features.

The product, which CEO Miles White called a key growth driver for Abbott, could benefit from a National Coverage Determination update by CMS. A proposed decision memo is expected by Feb. 14, 2020, with the national coverage analysis completion date expected by May 14, 2020.

"Reimbursement is going to be important, there will be definitely be an inflection point when we get it," Abbott COO Robert Ford said on the earnings call. 

Barbara Calvert, Abbott director of medical product reimbursement, wrote to CMS urging the payer to expand reimbursement for MitraClip in comments on the proposal.

"Given the life-saving benefit of the MitraClip therapy, as demonstrated in COAPT, we urge CMS to move as quickly as possible," Calvert wrote.

Cowen analysts predict MitraClip growth will continue when Abbott announces its 2019 fourth quarter results, noting it is set up to benefit from favorable tailwinds. 

"MitraClip growth continues to be fueled by the U.S. utilization ramp in the functional MR indication. Highly favorable COAPT results continue to resonate with clinicians in the form of improving procedure volumes even in front of CMS’ NCD update for FMR (likely by May 2020)," the analysts wrote in an equity research note.