Dive Brief:
- Johnson & Johnson has started patient enrollment in a pivotal trial to evaluate its Laminar left atrial appendage (LAA) elimination device for reducing stroke risk due to blood clot formation in the heart, the company said Tuesday.
- The investigational device exemption study will enroll 1,500 patients with atrial fibrillation (AFib), a common form of irregular heart rhythm, at up to 100 U.S. sites.
- J&J, which acquired privately held Laminar for $400 million in November, is among the medtech companies aiming to challenge Boston Scientific, whose Watchman implant leads the fast-growing market for LAA devices.
Dive Insight:
AFib, a condition in which the heart’s chambers beat out of sync, affects nearly 38 million patients globally. The LAA, a small sac in the heart’s left atrium, is a major source of blood clots in AFib patients, which can then enter the bloodstream and cause a stroke.
Boston Scientific has predicted the LAA closure market could quadruple to more than $6 billion by 2030.
Abbott makes a competing closure system, the Amplatzer Amulet, that seals off the LAA with a disc.
Other device makers are taking different approaches to treating the condition. Medtronic is now rolling out the Penditure system, which it acquired in August, that employs an implantable clip for LAA exclusion. The system is expected to compete directly with Atricure’s Atriclip. Meanwhile, J&J is differentiating itself with the Laminar system, which uses rotational motion to eliminate the LAA.
The company said its prospective, randomized pivotal study will compare the safety and efficacy of the Laminar system to commercially available LAA closure devices. Principal investigators for the clinical trial are Saibal Kar of Los Robles Health System in California and Devi Nair of St. Bernard’s Heart and Vascular Center in Jonesboro, Arkansas.
