Innovative Catheter Guidance Technology Aims for Zero Malpositioning

Millions of catheters are still being inserted each year without the use of guidance, posing unnecessary risks to patients. Blind insertions require confirmation through chest X-ray, which increases hospital costs, exposes patients to more radiation, and delays the start of medication infusion. Now, a new catheter guidance technology that utilizes intravascular cardiac electrical activity (ECG) offers an alternative method for confirming proper catheter placement, eliminating the need for chest X-rays.

Piccolo Medical (San Francisco, CA, USA) has developed the ECGuide technology, which uses the patient's ECG to determine the catheter tip position in real time. It has been approved as a substitute for chest X-rays to confirm correct catheter placement. While catheter guidance systems are commonly used in Peripherally Inserted Central Catheter (PICC) procedures, their adoption for Central Venous Catheter (CVC) procedures in the U.S. has been limited. Studies have shown that intravascular ECG technology enhances accuracy in both CVC and PICC placements and reduces complication rates.

Piccolo has now received clearance from the U.S. Food and Drug Administration (FDA) to market its PM2 System with ECGuide Connector, an innovative catheter guidance technology. This addition to Piccolo's product portfolio is aimed at reducing complications associated with central venous catheter insertions, a procedure that impacts over 8 million patients annually.

"Millions of catheters are still being inserted without guidance every year," said Augustus Shanahan, CEO of Piccolo Medical. "The evidence is clear: blind insertions pose unnecessary risks to patients and incur additional costs for hospitals. With the launch of ECGuide, we aim to overcome barriers related to cost and complexity, ultimately driving the industry towards a goal of zero malpositioning."

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