Automated vascular access device development

The National Heart, Lung, and Blood Institute awarded MDC Studio, Inc. $309,813 on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to develop an automated vascular access device that enables less-experienced providers to safely and reliably perform central venous and arterial cannulation.

The R61 phase focuses on automating the core steps of successful cannulation. MDC Studio will design, construct, and test sensors and automation to detect blood vessel puncture, distinguish artery from vein, and advance a guidewire into the vessel; the first milestone requires successful identification and cannulation of porcine femoral artery and vein in vivo in more than 8 out of 10 attempts with a guidewire. The recipient will then design, construct, and test a catheter system to cannulate the target vessel automatically; the second milestone requires demonstration of detection and successful cannulation of porcine artery and vein in vivo in greater than 4 out of 5 attempts with a catheter, completing the R61 phase. The R33 phase will involve designing and engineering a sterile, patient-specific, disposable cassette to interface with the reusable device base unit and beginning the regulatory process for FDA submission.

Work is performed in Baltimore, Maryland. The period of performance runs from September 1, 2026, through June 30, 2028. This is a Project Grant, a form of assistance funding supporting small-business-led development of cardiovascular technologies.

Abstract

Central venous catheterization and arterial cannulation are lifesaving procedures performed 5-7 million times per year in the U.S., often by less-experienced providers in urgent situations. High rates of complication and failure (4-19%) remain a problem, even with ultrasound guidance. The ability of less experienced providers to safely and effectively achieve arterial and central venous access is a significant unmet need in emergency medicine, trauma and critical care. Vascular rescue is developing a portable, self-contained, self-powered, semi- automated vascular access device (avad) that will allow less-than-experienced providers to safely, quickly, and reliably achieve central venous and arterial cannulation. The overall goal of this catalyze proposal is to move the avad prototype to successful automated cannulation of the target vessel by the sheath, which competing devices cannot do. In the R61 phase we will automate all the steps of successful cannulation. In the R33 phase we will design and build the sterile patient-specific cassette and begin the regulatory process for FDA submission. (R61) aim 1: to design, construct and test sensors and automation to detect puncture of a blood vessel, distinguish artery VS. Vein and advance a guidewire into the vessel. R61 milestone 1: successful identification and cannulation of a porcine femoral artery and vein in vivo (more than 8 out of 10 attempts) with a guidewire. (R61) aim 2: to design construct and test a catheter system to cannulate the target vessel automatically. R61 milestone 2: to demonstrate detection and successful cannulation of a porcine artery and vein in vivo (greater than 4 out of 5 attempts) with a catheter. This will be the pivotal milestone that will complete the R61 phase of the project. (R33) aim 3: to design and engineer the sterile cassette (patient-specific and disposable) to interface with the reuseable avad base unit to puncture and cannulate vessels. R33 milestone 3: demonstrate in a porcine or cadaver model (>5 cases) a functional interface for vascular cannulation between a sterilizable disposable cassette and the avad base unit. (R33) aim 4: generate a regulatory path document to define milestones for FDA submission. Funding of the catalyze proposal will align and integrate our device development team with the expertise of the accelerator partners to bring this life-saving technology forward towards widespread clinical use.