Technology
A mechanical-first approach to a procedure that's been waiting for one.
PreciSept is built around how operators want transseptal access to work — anchored before crossing, controlled throughout, and compatible with the tools already in the lab.
Context
Why transseptal access still varies operator to operator.
Transseptal puncture is a small step with outsized consequences. Even with modern tools, outcomes vary by operator experience, anatomy, and preferred technique. Existing crossing technologies have incrementally improved this step — but most still require the operator to commit to a crossing before the device is fully stabilized at the target site.
We believe the right answer is to separate two actions that have always been bundled: securing the position, then crossing. PreciSept is engineered around that distinction.
Workflow
Anchor. Cross. Lock.
A helical tip engages the septal tissue with a controlled quarter-turn. The wire is mechanically stable at the target site before any energy is applied. The operator confirms position before committing to a crossing.
Low-power RF assist completes the crossing through the anchored tip. Optimized energy delivery enables crossing through varied septal thicknesses with minimal collateral effect.
Once across, the wire forms a J-shape in the left atrium — a stable rail for sheath advancement, exchange, and tool delivery. No re-puncture, no re-crossing, no transition to a separate wire.
Designed for the lab you already have
A platform, not a closed system.
PreciSept is being developed for compatibility with the introducer sheaths and dilators already in routine use. Our hypothesis: operators don't want a new ecosystem — they want a better wire that fits the one they have. Universal compatibility is a design constraint, not an afterthought.
IP
Two issued US patents. Freedom-to-operate complete.
PreciSept's underlying technology is protected by two issued United States patents covering needleless transseptal access and RF-assisted crossing. An independent freedom-to-operate analysis has been completed by outside IP counsel; no blocking claims were identified. Additional applications are in progress around future enhancements.
Regulatory
FDA 510(k), with predicate devices identified.
PreciSept's regulatory pathway is a U.S. FDA 510(k) submission. Two cleared transseptal access devices have been identified as candidate predicates. We are working with an external regulatory consultant on pre-submission strategy.