The Device

What Is the Stiletto?

The Stiletto is a midline catheter -- a medium-length IV line that sits in the upper arm for 1-4 weeks. It's used when patients need IV therapy longer than a standard peripheral IV can handle but don't need a full central line (PICC).

Common use cases:

• Outpatient antibiotics (OPAT) -- patients going home with IV antibiotics
• Chemotherapy access -- reliable access for infusion cycles
• TPN administration -- nutrition delivery
• Difficult IV access patients -- patients whose veins are hard to find or keep

Manufacturer: Piper Access (brand: Avia Vascular)

FDA clearance: 510(k) K210047 (2021)

Power injectable: Yes -- CT contrast compatible (300 psi, 5ml/sec)

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The Problem It Solves

Every other midline catheter on the market uses a guidewire to thread the catheter into the vein. The insertion process:

Standard midline (BD PowerGlide): 5 steps

1. Insert needle into vein
2. Feed guidewire through needle
3. Thread catheter over guidewire
4. Remove guidewire
5. Confirm placement

The guidewire is where things go wrong. It can kink, knot, or fracture. When a catheter gets pulled back across the needle bevel, the sharp edge can shear the catheter tip. In BD's Power product line, 90% of extracted failure modes are mechanical (n=90 extracted events), and guidewire-related failures are a recurring pattern in event narratives.

Those aren't abstractions. They mean:

• Retained catheter fragments requiring surgical retrieval ($15-30K per event)
• X-ray to find the fragment, interventional radiology consult, retrieval procedure
• Patient harm, extended hospital stays, litigation risk

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How SlipStream Technology Works

Stiletto insertion: 2 steps

1. Insert needle into vein
2. Advance catheter (SlipStream threads it without a guidewire)

That's it. No guidewire to feed, no wire to remove, no wire to kink or fracture.

SlipStream Technology uses a proprietary mechanism to advance the catheter without a guidewire. The result:

• Zero guidewire failures -- the mechanism that causes kinking, knotting, and fracturing doesn't exist
• Fewer procedural steps -- 2 vs 5
• Lower cognitive load -- less can go wrong during difficult insertions
• Faster insertion time -- fewer steps = faster completion

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Who Uses It

Primary users: Vascular access teams -- specialized nurses who place midlines and PICCs

Settings:

• Hospitals (inpatient and outpatient)
• Infusion centers
• Oncology clinics
• Home health (placement before discharge)

Decision makers:

• Vascular Access Director -- selects the device
• Value Analysis Committee -- approves the purchase
• Chief Nursing Officer -- strategic alignment
• Risk Manager -- liability assessment

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A Note on MAUDE Event Counts

MAUDE event counts correlate strongly with market share. BD has ~40% of the vascular access market and hundreds of thousands of devices in the field. Stiletto has <5% market share with far fewer devices deployed. Comparing raw event totals between these two products is comparing installed base, not safety.

The meaningful comparisons are:

• Injury rates per event -- what percentage of reported events result in patient harm
• Failure mode patterns -- are the same mechanical failures repeating across facilities
• Root cause distribution -- is the manufacturer attributing failures to users vs. design

These rate-based and pattern-based analyses are covered in the Competitive Landscape section.

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Specifications

Spec	Stiletto	BD PowerGlide
Insertion mechanism	SlipStream (guidewire-free)	Guidewire
Insertion steps	2	5
Power injectable	Yes	Yes
Pressure rating	300 psi	300 psi
Flow rate	5 ml/sec	5 ml/sec
FDA clearance	K210047 (2021)	Various

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Positioning Statement

For vascular access teams who need reliable extended dwell access, Stiletto is the only midline catheter that eliminates guidewire failure modes because SlipStream Technology threads without a guidewire.

Tagline: The only midline that eliminates guidewire failure modes.

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Data: FDA MAUDE database, FDA 510(k) clearance records.