SAN FRANCISCO, Feb. 22, 2021 /PRNewswire/ — Piccolo Medical, Inc. proclaims that it has obtained FDA clearance of its SmartPICC™ System.
The SmartPICC™ System gives caregivers the power to navigate peripherally inserted central catheters (PICCs) to the entryway of the guts with out counting on x-ray or fluoroscopy affirmation of appropriate catheter placement. Over Three million PICCs are positioned within the US per 12 months, with roughly 500,000 per 12 months positioned in sufferers with coronary heart arrhythmias.1,2 Conventional PICCs which are positioned on the bedside with out steerage methods lead to optimum tip place in solely 34% of sufferers, rising dangers for problems; 19% require repositioning including value and delaying care.3
The SmartPICC System gives real-time catheter tip location data utilizing each the affected person’s cardiac electrical exercise and a proprietary sensing know-how referred to as ionic dilution, which gives real-time qualitative blood move data to the caregiver to help in catheter navigation.
“We’re excited to announce the industrial availability of the SmartPICC system to assist the tens of millions of sufferers that require a PICC catheter yearly,” mentioned Piccolo Medical CEO Alexey Salamini. “With the mixed advantages of twin unbiased sensing mechanisms, lack of high-priced reusable capital tools and decrease total value to the hospital methods we count on the SmartPICC to quickly grow to be customary of care within the business.”
The twin sensor know-how matches on a wire roughly 4-5 occasions the diameter of a human hair which will be simply threaded inside a PICC catheter. As well as, the SmartPICC requires no exterior chest piece, a potential fomite and supply of transmission of an infection.
“Given all the benefits of the ionic dilution and ECG (ID-ECG) mixture know-how, the Piccolo SmartPICC System has the potential to grow to be the brand new gold customary for bedside PICC and central venous catheter navigation and tip location methods,” mentioned Dr. Greg Schears of the Mayo Clinic. “I stay up for additional medical analysis to exhibit its efficacy within the presently underserved inhabitants of sufferers with arrhythmias.”
About Piccolo Medical:
Piccolo Medical Inc. was spun out of the Theranova medical gadget incubator in San Francisco, CA. It has been funded by personal traders but in addition by prestigious Part I and II grant awards from the Nationwide Institute of Well being’s Nationwide Institute of Ageing. Theranova has spun out a number of different profitable medical gadget corporations with merchandise in the marketplace within the US and EU.
1 A worldwide problem, a world perspective in Stopping Central Line-Related Bloodstream Infections, Lori Meek Schuldt CW, Editor. 2012, The Joint Fee.
2 Dale M. Higgins A, Carolan-Rees G (2016). Sherlock 3cG((r)) tip affirmation system for placement of peripherally inserted central catheters. A NICE medical know-how steerage. Appl Well being Econ Well being Coverage 14(1):41-49.
3 Keller EJ, Semaan E, Lee J, Aragona E, Molina H, et al. (2016). The direct and oblique prices of ultrasound-guided peripherally inserted central catheter repositioning at a big tutorial medical heart. Journal of the Affiliation for Vascular Entry 21(4):230-236.
SOURCE Piccolo Medical