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 validation complete. Pursuing U.S. regulatory clearance.
Preclinical testing complete
PreciSept has completed initial in-vivo preclinical testing. Results support the device's core mechanism of action across multiple crossing modalities.
Regulatory clearance
PreciSept is pursuing U.S. regulatory clearance. Two cleared transseptal access devices have been identified as candidate predicates, and external regulatory consultants are supporting submission planning.
Issued patents
Two issued U.S. patents covering needleless transseptal access and RF-assisted crossing technology. Additional applications are in progress.
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.
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