SentreHeart yesterday touted the first-in-human procedures involving its Lariat left atrial appendage closure device to reduce the risk of stroke in patients with atrial fibrillation.
The initial nine procedures, performed by Drs. Kryzstof Bartus and Randy Lee at Krakow, Poland’s John Paul II hospital, used the EpiRail vacuum stabilization system for an epicardial-only, percutaneous approach that avoids transseptal catheterization. Lariat is designed to close off the LAA from the exterior of the heart using a pre-tied suture.
Redwood City, Calif.-based SentreHeart is running a 600-patient trial comparing Lariat and pulmonary vein isolation with PVI alone in treating atrial fibrillation.
“The Lariat with EpiRail is a true game changer in the area of percutaneous LAA closure,” Bartus said in prepared remarks. “The benefits we have seen in this early experience is the elimination of transseptal catheterization, no manipulation within the heart that may lead to thrombus formation, and no use of contrast in the heart which will be a benefit to patients with renal disease.”
“The initial experience with the EpiRail approach with the Lariat device for percutaneous LAA closure has been outstanding and is a revolutionary advancement. Epicardial visualization of the LAA via the EpiRail approach allows for the Lariat snare to easily be passed over the LAA resulting in a faster and safer LAA closure procedure,” Lee added.