Piccolo Medical has announced that it has received US Food and Drug Administration (FDA) clearance of its SmartPICC system.
The SmartPICC system offers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without the use of X-ray or fluoroscopy confirmation of correct catheter placement.
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.”
“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 Greg Schears of the Mayo Clinic, Rochester, USA. “I look forward to further clinical evaluation to demonstrate its efficacy in the currently underserved population of patients with arrhythmias.”