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FirstPass™ Forward Emitting IVL.

Innovative technology designed with the CTO in mind — invented by a clinician, for clinicians.*

Overview

A time saving choice for crossing CTOs.

FirstPass* is IVL technology created as a time saving choice for crossing CTOs more efficiently and less traumatically.

FirstPass is a truly forward-emitting intravascular lithotripsy (IVL) catheter optimized for crossing the heavily calcified proximal cap of peripheral Chronic Total Occlusions (CTOs). It is designed to deliver pulsatile sonic pressure waves from the catheter tip to fracture calcium and dense fibrous tissue in the cap — without requiring a guidewire to cross first.

That enables controlled, atraumatic guidewire penetration, followed by standard revascularization.

Designed for

  • True forward energy delivery — focused at the distal tip, no balloon pre-dilation needed.
  • Safety — designed to help limit dissection and perforation risk compared with aggressive atherectomy.
  • Efficiency — reduces steps, time and reliance on retrograde access; designed to reduce radiation and contrast use.
  • Deliverability — designed for a low profile and smooth delivery, with sizes planned for above- and below-the-knee applications.

Concept animation, not to scale. FirstPass is under development and not FDA cleared.

How it works

Fracture the cap. Cross the lesion.

  1. Artery with a 100% calcified blockageThe wire cannot cross the plaque.
  2. End-emitting IVL catheterLithotripsy energy is delivered forward, directly ahead of the tip.
  3. The catheter advances, creating a channelPulses fracture the calcium ahead of the tip, without a wire having to cross first.
  4. The wire can now crossThe catheter is withdrawn, a guidewire passed, and standard revascularization therapy can follow.
Differentiation

Forward facing — not just forward-ish.

Current intravascular lithotripsy platforms primarily deliver energy radially and are generally used once a guidewire has already crossed the lesion. Lesions that cannot be crossed remain a challenge. FirstPass focuses lithotripsy energy forward, at the tip, to fracture dense calcium directly in front of the catheter.

Truly forward-emitting

A prototype refined through numerous iterations to generate true distal delivery of lithotripsy for modifying a calcified CTO cap or other heavily calcified lesion — with strategic IP applicable to structural heart applications to support.

No guidewire needed first

Differentiated from other available IVL devices, FirstPass is designed so that a guidewire does not need to cross the treatment site first.

Less traumatic

Designed to modify the calcified cap in place, supporting controlled guidewire penetration rather than forcing a path through the vessel wall.

Benefit vision

Problem → Solution → Triple benefit.

Clinician

  • Safely cross CTOs
  • Increase treatment options
  • Reduce case time & waste

Patient

  • Reduce amputations
  • Improve outcomes
  • Improve quality of life

Facility — OBL / ASC / Hospital

  • Aligned with the shift to outpatient care
  • Expanded CMS reimbursement for peripheral procedures in ASCs and OBLs (January 2026)
Development status

Prototype progress.

Based on functional bench testing and visual inspection, our end-emitting lithotripsy catheter crossed both gypsum models and calcified human artery specimens.

FirstPass prototype catheter distal tip, side view
Prototype distal tip — side view
FirstPass prototype tip held between fingers for scale
Prototype tip, shown for scale
End-on view of the FirstPass prototype tip
End-on view of the emitting tip
FirstPass prototype catheter with hub and Y-connector
Catheter hub and connector
Two FirstPass prototype catheters
Prototype catheters
FirstPass prototype distal tip
Distal tip detail

Images show prototype devices under development.

What’s next

*FirstPass™ is currently under development and is not FDA cleared. It is not available for sale. Descriptions of FirstPass reflect design intent and early bench testing; safety and effectiveness have not been established.

For More Information

To learn more about Ropana Vascular’s Regulatory and Development Pathway, connect with us.

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