The Upstream Access system is a multidirectional vascular access device that allows clinicians to treat disease in any direction from a single puncture site.
Current vascular sheaths only allow devices to travel in one direction. The Upstream Access system solves this fundamental limitation with two key innovations:
An atraumatic balloon secures the sheath within the vessel, preventing accidental dislodgement and maintaining stable access throughout the procedure.
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.
The Upstream Access system includes three key components, all designed to work with standard endovascular equipment.
The novel patentable component. A standard-profile sheath with an integrated atraumatic balloon that anchors securely in the vessel lumen.
A specially shaped catheter that redirects within the vessel, enabling retrograde access. Uses familiar catheter technology clinicians already trust.
A standard dilator that sits inside the sheath during insertion, facilitating smooth vessel entry and transition to the access configuration.
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
Balloon
Most Optimal
U-Prong
Double Strut
Single Strut
The Upstream Access system has been validated through animal proof-of-concept testing, demonstrating successful multidirectional sheath placement.
Functional prototypes including sheath, balloon anchor, dilator, and U-turn catheter successfully manufactured.
Successful proof of concept demonstrating bidirectional access from a single femoral entry point.
Currently in active design refinement phase, optimizing balloon anchor performance and sheath profile for clinical use.
The Upstream Access device is pursuing a 510(k) clearance pathway, the most common and efficient regulatory route for medical devices with predicate comparisons.
The device builds on well-established vascular sheath and catheter technologies, providing clear predicate devices for regulatory comparison and submission.
The 510(k) pathway enables a faster route to market compared to PMA, with design verification, validation testing, and submission targeting clearance efficiently.
We're seeking strategic partners and licensees across vascular surgery, cardiology, and interventional radiology.
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