Transseptal access, reimagined
Accessing the heart with precision, not puncture.
PreciSept is a universal, needleless transseptal guidewire — engineered for predictable left-heart access in structural heart, electrophysiology, and beyond.
Investigational device · Not available for sale in the US
The shift
Left-heart procedures are growing. Access has not kept up.
Transseptal access is the foundation of nearly every left-heart intervention — atrial fibrillation ablation, left atrial appendage occlusion, mitral and tricuspid repair, pulsed-field ablation. Procedural volumes are climbing fast. Yet the crossing step remains one of the least standardized and most variable parts of the workflow.
PreciSept is designed to change that — a single, universal device built around how operators actually want to work.
The PreciSept workflow
Anchor. Cross. Lock.
Three steps, one wire. Engineered to separate stabilization from crossing — so operators commit to a position before they commit to an action.
Anchor
A helical tip engages the septum mechanically, stabilizing the device at the target before any energy is applied.
Cross
Low-power RF assist completes the crossing — gentle, controlled, and integrated into the same wire.
Lock
The wire forms a J-shape inside the left atrium, creating a stable rail for sheath advancement and tool exchange.
Open by design
One wire. Any sheath. Any procedure.
PreciSept is being developed as a universal, licensable platform — engineered to work with the introducer sheaths and dilators operators already use. No vendor lock-in. No new hardware footprint. Just better access.
Status
Preclinical, with bench data and an FDA pathway in motion.
Bench data complete
PreciSept's V1 prototype has completed ex-vivo benchtop testing. Animal studies are next.
FDA 510(k) pathway
Regulatory pathway is FDA 510(k), with two cleared predicate devices identified. Engaged with an external regulatory consultant for pre-submission strategy.
Issued patents
Two issued US patents covering needleless transseptal access and RF-assisted crossing technology.
Freedom to operate
Independent freedom-to-operate analysis is complete. No blocking claims identified.
Building the foundational layer for left-heart intervention.
We're raising a seed round and building partnerships with strategics. If that's relevant to you, let's talk.
Request a meeting