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PreciSept

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 critical step with outsized consequences. Even with modern tools, outcomes still vary by operator experience, anatomy, and technique.

Existing crossing technologies have improved this step incrementally — but most still require the operator to commit to crossing before the system is fully stabilized at the intended target.

PreciSept addresses this fundamental limitation by separating two actions that have historically been coupled: precise positioning and controlled crossing.

By enabling secure stabilization before crossing, the system introduces controlled optionality — allowing the operator to select the most appropriate crossing strategy based on anatomy and procedural context.

Workflow

Anchor. Cross. Lock.

01 — Anchor

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.

02 — Cross

Low-power RF assist completes the crossing through the anchored tip. Optimized energy delivery enables crossing through varied septal thicknesses with minimal collateral effect.

03 — Lock

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 U.S. patents protect the core technology.

PreciSept's underlying technology is protected by two issued United States patents covering needleless transseptal access and RF-assisted crossing. Additional applications are in progress around future enhancements.

Regulatory

Pursuing U.S. 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.

Investigational device. PreciSept is an investigational device and is not currently cleared or approved for sale by the U.S. Food and Drug Administration or any other regulatory body. CAUTION: Investigational device. Limited by federal (or United States) law to investigational use.

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