# A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement

> **NIH NIH SB1** · PICCOLO MEDICAL, INC. · 2024 · $1,324,870

## Abstract

Abstract
In the United States alone, more than three million peripherally inserted central catheters (PICCs) are placed
each year to provide IV therapies, where in about half of cases navigation through the venous system is
typically performed blind, or without navigation guidance. Improper PICC placement is relatively common, is
costly, and has serious complications for critically-ill patients. Unfortunately, under blind placement 30-55% of
PICC tips are not optimally placed on the first attempt and require repositioning, which has an average direct
cost of $223 per patient and often necessitates the removal and reinsertion of the catheter line that carries a
4-6% risk of pneumothorax. Moreover, approximately 17% of these improperly positioned PICCs are placed
into the right atrium, which is associated with a multitude of life-threatening complications. Improper placement
of PICCs also often requires referral to an interventional radiologist for fluoroscopic-guided central line
placement, which is expensive ($1,000) and requires more radiation exposure for the patient. Not surprisingly,
over half of all PICCs are administered to patients over the age of 60. Therefore, safe and accurate PICC
placement is critical for providing high-quality care to older Americans. Despite serious adverse events
associated with blind placement of PICC lines, current vascular access systems have not been widely adopted.
The Teleflex ARROW® G4 VPS and the Bard Sherlock 3CG® TCS are PICC guidance systems that employ
ECG for positioning the PICC tip into the correct location: the region that includes the lower superior vena cava
(SVC) and cavoatrial junction (CAJ). While these procedures often limit the need for a confirmatory X-ray, they
have poor and variable successful placement rates (44-84%), are 30-70% more expensive than standard
PICCs, require skilled staff, and have significantly longer procedure times as compared to standard, blind PICC
placement. Additionally, these guidance systems rely solely on the use of ECG, which is ineffective for patients
with cardiac arrhythmias, a condition that affects approximately 16% of all patients requiring a PICC line. To
address the need for accurate, safe, and cost-effective PICC placement, Piccolo Medical has developed the
Smart PICC™ system, a point-of-care catheter system that uses unique hemodynamic signatures of different
vascular regions in combination with ECG for real-time vascular access guidance into the SVC/CAJ. The goal
of this Commercialization Readiness Pilot (CRP) is to support the commercialization of a cost competitive
Smart PICC™ system in the vascular access marketplace. First, we will design a Gen 2 Smart PICC™
system with improved usability and performance, and reduced cost of goods sold (COGS) to enable
commercial launch (Aim 1). Second, we will submit a 510(k) to the FDA for the Smart PICC™ Gen 2 system
(Aim 2). The successful completion of these Aims will allow us to commercialize this refined syst...

## Key facts

- **NIH application ID:** 10932381
- **Project number:** 5SB1AG060793-05
- **Recipient organization:** PICCOLO MEDICAL, INC.
- **Principal Investigator:** Augustus Shanahan
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,324,870
- **Award type:** 5
- **Project period:** 2018-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10932381

## Citation

> US National Institutes of Health, RePORTER application 10932381, A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement (5SB1AG060793-05). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10932381. Licensed CC0.

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