Dive Brief:

• Abbott on Monday said it received FDA approval for the latest iteration of its MitraClip device with new features that allow for greater customization of the minimally invasive mitral valve repair procedure. 
• Called MitraClip G4, the fourth generation of the heart device, offers an expanded range of clip sizes, an alternative leaflet grasping technology, and integration with a pressure monitor for real-time assessment during implant. 
• First approved in the United States in 2013, the catheter-based alternative to open heart surgery for reduction of mitral valve regurgitation has been used to treat more than 80,000 patients worldwide, the company said.

Dive Insight:

CEO Miles White kicked off Abbott’s first quarter earnings call in April by singling out MitraClip, along with the FreeStyle Libre glucose monitor and the Alinity blood and plasma screening systems as key long-term growth drivers for the company. Abbott’s structural heart business, which includes MitraClip, posted sales growth of nearly 25% in the first quarter.

The company has had the minimally invasive mitral repair sector to itself, but competitors are eyeing the space. Boston Scientific plans to launch a U.S. feasibility study next year for mitral valve repair technology it acquired in its 2018 purchase of Millipede.

Edwards Lifesciences, the pioneer in transcatheter aortic valve replacement, is further along. Its Pascal mitral repair system gained a CE mark in February, and the company in May reported six-month data from a U.S. clinical trial of the device. In March, Edwards acquired assets of Mitralign, a transcatheter annuloplasty system to treat both mitral and tricuspid regurgitation.

Delivered to the heart through a small incision in the leg, MitraClip was approved initially for patients with primary mitral regurgitation involving leakage due to the structure of the valve. The device clips together the two leaflets of the mitral valve to reduce the backflow of blood so the heart can pump more efficiently. 

Abbott gained an expanded indication in March for use of MitraClip in a broader population of heart failure patients with secondary mitral regurgitation. In those patients, the left chamber has become enlarged, preventing the mitral leaflets from closing normally. The company is seeking expanded Medicare coverage to reflect the broader label.

The MitraClip G4, cleared via a PMA supplement, treats both primary and secondary mitral regurgitation. The device has four clip sizes, including options with wider grasping area. Also new are independently controlled grippers that allow the physician to grasp one or both leaflets during the procedure.

An upgraded catheter in the G4 device integrates a commercially available pressure monitor to allow continuous left atrial assessment during implant. The monitor confirms mitral regurgitation reduction to help the physician determine whether the device should be repositioned to optimize patient outcomes.

Abbott is also working on a tricuspid repair device called TriClip and in February initiated an early feasibility study to assess the safety and performance of Pascal in tricuspid regurgitation. The company’s Cardioband tricuspid reconstruction system received CE mark in April 2018, and an early U.S. feasibility study is underway.