St. Jude Medical (St. Paul, Minnesota) last week reported FDA clearance and a Health Canada License for the ACross Transseptal Access System, a device designed to improve control and simplify the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation (AF) ablation.
The device is used to reach the left atrium of the heart, which is difficult to access but where some of the most complex arrhythmias occur, St. Jude said.
“It’s much easier to reach the right side of the heart than the left side of the heart,” Kathleen Janasz, a spokesperson for St. Jude Medical, told Medical Device Daily.
“The sheath, dilator and needle are all consolidated in the ACross system and allows the physician to have more control,” Janasz said. “It’s one device as opposed to three.”
Another advantage to using the ACross system versus traditional methods, Janasz said, is that the device’s handle allows the components to fit precisely together, ensuring that the puncture needle is not deployed until the physician is confident in its location, and that it is only advanced a pre-determined distance.
Also, St. Jude noted, the ergonomic design of the device incorporates a directional fin, or ridge, on the handle, so that the physician will intuitively know the orientation of the needle and sheath tip within the heart.
Janasz told MDD that she is “not aware of any other device like it.”
The device was first used at Southlake Regional Health Centre (Newmarket, Ontario) by Atul Verma, MD, and Yaariv Khaykin, MD.
“The ACross System brings consistency and simplicity to a procedure which can be complex and challenging,” Khaykin said. “While ACross uses techniques and approaches that have been employed by [electrophysiologists (EPs)] for many years, its enhanced tools simplify the procedure and add safeguards for some of the most critical steps.”
Because there is no direct path to the left atrium to deliver therapy, EPs use a long, curved needle to puncture the septum, or wall, between the left and right atrium and pass a sheath into the left chamber. The process of making this puncture and creating a conduit to the left atrium is called a “transseptal” procedure, the company said.
Traditional transseptal tools require clinicians to simultaneously manipulate a separate needle, dilator, and sheath, maintaining precise distances between each component and their angles relative to the patient’s anatomy. This complex procedure may often require two or more people to manipulate the various components to prevent potential complications due to inadvertent needle deployment or improper orientation, St. Jude said.
The ACross Transseptal System is part of a growing portfolio of access, diagnosis, visualization and therapy products provided by St. Jud to help physicians serve the unmet clinical needs of patients with cardiac arrhythmias, the company noted.
St. Jude has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.