Multidirectional Access from a Single Needle Stick

Current vascular sheaths only allow devices to travel in one direction. The Upstream Access system solves this fundamental limitation with two key innovations:

1

Balloon-Anchored Sheath

An atraumatic balloon secures the sheath within the vessel, preventing accidental dislodgement and maintaining stable access throughout the procedure.

2

U-Turn Catheter

A specialized catheter enables devices to reverse direction within the vessel, allowing treatment of the contralateral limb or upstream anatomy from the same access point.

Access Point Antegrade Retrograde Distal Proximal Single Access Point  •  Multidirectional Treatment Sheath U-Turn Catheter

What's in the Kit

The Upstream Access system includes three key components, all designed to work with standard endovascular equipment.

Sheath with Balloon Anchor

The novel patentable component. A standard-profile sheath with an integrated atraumatic balloon that anchors securely in the vessel lumen.

Patent Protected

U-Turn Catheter

A specially shaped catheter that redirects within the vessel, enabling retrograde access. Uses familiar catheter technology clinicians already trust.

Dilator

A standard dilator that sits inside the sheath during insertion, facilitating smooth vessel entry and transition to the access configuration.

Protected Innovation

Our IP portfolio covers the core multidirectional access technology and multiple anchor design configurations.

Patent Application 1

Multidirectional Blood Vessel Entry Device

US Filed 09/20/2024

Patent Application 2

Antegrade Femoral Artery Entry Device and Sheath

US Filed 04/05/2022

Anchor Designs Covered

Balloon

Most Optimal

U-Prong

Double Strut

Single Strut

Proven in Preclinical Testing

The Upstream Access system has been validated through animal proof-of-concept testing, demonstrating successful multidirectional sheath placement.

Prototype Developed

Functional prototypes including sheath, balloon anchor, dilator, and U-turn catheter successfully manufactured.

Animal Study Complete

Successful proof of concept demonstrating bidirectional access from a single femoral entry point.

Design Refinement

Currently in active design refinement phase, optimizing balloon anchor performance and sheath profile for clinical use.

Clear Path to Market

FDA 510(k) Pathway

The Upstream Access device is pursuing a 510(k) clearance pathway, the most common and efficient regulatory route for medical devices with predicate comparisons.

Established Predicates

The device builds on well-established vascular sheath and catheter technologies, providing clear predicate devices for regulatory comparison and submission.

Streamlined Timeline

The 510(k) pathway enables a faster route to market compared to PMA, with design verification, validation testing, and submission targeting clearance efficiently.

Explore Partnership Opportunities

We're seeking strategic partners and licensees across vascular surgery, cardiology, and interventional radiology.

Get in Touch