Piccolo Medical Receives U.S. FDA Clearance of its SmartPICC™ System for the positioning of Peripherally Inserted Central Catheters

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Feb 22, 2021, 10:53 ET

SAN FRANCISCO, Feb. 22, 2021 /PRNewswire/ -- Piccolo Medical, Inc. announces that it has received FDA clearance of its SmartPICC™ System.

The SmartPICC™ System provides caregivers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without relying on x-ray or fluoroscopy confirmation of correct catheter placement. Over 3 million PICCs are placed in the US per year, with approximately 500,000 per year placed in patients with heart arrhythmias.^1,2 Traditional PICCs that are placed at the bedside without guidance systems result in optimal tip position in only 34% of patients, increasing risks for complications; 19% require repositioning adding cost and delaying care.³

The SmartPICC System provides real-time catheter tip location information using both the patient's cardiac electrical activity and a proprietary sensing technology called ionic dilution, which provides real-time qualitative blood flow information to the caregiver to aid in catheter navigation.

"We are excited to announce the commercial availability of the SmartPICC system to help the millions of patients that require a PICC catheter every year," said Piccolo Medical CEO Alexey Salamini. "With the combined benefits of dual independent sensing mechanisms, lack of expensive reusable capital equipment and lower overall cost to the hospital systems we expect the SmartPICC to rapidly become standard of care in the industry."

The dual sensor technology fits on a wire approximately 4-5 times the diameter of a human hair which can be easily threaded inside a PICC catheter. In addition, the SmartPICC requires no external chest piece, a possible fomite and source of transmission of infection.

"Given all of the advantages of the ionic dilution and ECG (ID-ECG) combination technology, the Piccolo SmartPICC System has the potential to become the new gold standard for bedside PICC and central venous catheter navigation and tip location systems," said Dr. Greg Schears of the Mayo Clinic. "I look forward to further clinical evaluation to demonstrate its efficacy in the currently underserved population of patients with arrhythmias."

About Piccolo Medical:

Piccolo Medical Inc. was spun out of the Theranova medical device incubator in San Francisco, CA. It has been funded by private investors but also by prestigious Phase I and II grant awards from the National Institute of Health's National Institute of Aging. Theranova has spun out several other successful medical device companies with products on the market in the US and EU.

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¹ A global challenge, a global perspective in Preventing Central Line-Associated Bloodstream Infections, Lori Meek Schuldt CW, Editor. 2012, The Joint Commission.
² Dale M. Higgins A, Carolan-Rees G (2016). Sherlock 3cG((r)) tip confirmation system for placement of peripherally inserted central catheters. A NICE medical technology guidance. Appl Health Econ Health Policy 14(1):41-49.
³ Keller EJ, Semaan E, Lee J, Aragona E, Molina H, et al. (2016). The direct and indirect costs of ultrasound-guided peripherally inserted central catheter repositioning at a large academic medical center. Journal of the Association for Vascular Access 21(4):230-236.

SOURCE Piccolo Medical