(Suction Activated Patent Hemostasis)

How it works

SAPH System

Designed to support flow-preserving radial hemostasis

Full SAPH system with sheath

Syringe pulling plunger

SAPH Band

How it Works

SAPH is designed to achieve hemostasis after transradial procedures—without collapsing the artery. Here’s how it works:

1. Align

The integrated notch guides precise positioning over the sheath entry site.

2. Activate

A 20 cc syringe generates gentle negative pressure, drawing the arteriotomy toward the soft pad.

3. Secure

A one-way valve maintains the vacuum seal; no manual titration or incremental deflation required.

4. Release

After the prescribed dwell time, the valve is opened to equalize pressure and allow removal of the device.

Key Advantages: SAPH is designed to

Support patent hemostasis without circumferential compression

Preserve arterial flow to help maintain future access

Be fully topical — no sutures, implants, or subdermal components

Help reduce pressure-related discomfort

Simplify workflow and minimize staff burden

Evidence at a Glance

  • Confirms the advantage of flow-preserving, non-compressive closure—SAPH achieves this through suction-based hemostasis.

    Minor et al., 2021 (J Invasive Cardiol) – Randomized Trial of VasoStat vs TR Band

    Explore the evidence

  • Eliminates uncertainty around banding protocols by achieving immediate, patent hemostasis without prolonged compression.

    Maqsood et al., 2023 (Circ Cardiovasc Interv) – Meta-analysis of Hemostasis Band

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  • By preserving flow without compression, SAPH directly addresses the key causes of RAO.

    Avdikos et al., 2017 (Cardiovasc Diagn Ther) – Review of Radial Artery Occlusion

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  • Underscores the need for safer, flow-preserving closure without added radiation—what SAPH delivers.

    Dobies et al., 2016 (Open Heart) – Registry Analysis of Radial vs Femoral PCI

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“The current hemo static therapies take time and create repetitive tasks from the nursing staff to remove the air. I see that the air removal protocols cannot realistically be followed.

Also, radial artery occlusion is a growing issue. Patients are coming in, sometimes at a young age and your typical CAD patient is going to require multiple caths throughout their lifetime, we hate to lose an access site.”

Bailey Estes

AGNP-C, MSN; Cardiac Cath Lab Scrub Nurse and Researcher; Co-Chair of the ACC Cardiovascular Team Communications Work Group; Cath Lab Digest Editorial Board Greater Abilene Area

Early Clinical Experience (Data on File)

17-patient first-in-human series:

100% acute hemostasis; 0% RAO observed; no device-related complications. Early clinical experience not powered for definitive safety or effectiveness conclusions.

Prospective 50-patient study ongoing to evaluate workflow efficiency, safety, and comfort

Designed for regulatory submission under FDA 510(k) pathway (predicate classification: vascular clamp/ compression, 21 CFR 870.4450).

SAPH is not yet FDA cleared, it is for investigational use only.

Aligned with Published Best Practices

SAPH is designed in accordance with published radial-first access and patent-hemostasis protocols that emphasize:

  • Preservation of arterial flow

  • Reduction of RAO Risk Factors

  • Enhanced patient comfort and recovery