Getinge announces U.S. Food and Drug Administration 510(k) clearance for PulsioFlex Monitoring System and PiCCO Module

WAYNE, N.J, Feb. 23, 2018 /PRNewswire/ -- Getinge, a leading global provider of innovative medical technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its PulsioFlex Monitoring System and PiCCO Module. The PulsioFlex Monitoring System, from Getinge's Maquet brand, is a diagnostic aid used to measure and monitor blood pressure and cardiopulmonary, circulatory and organ function variables in patients in intensive care units (ICUs). The accompanying PiCCO Module is used for hemodynamic management of critically ill patients. It provides cardiac output measurement continuously based on pulse contour analysis and intermittently through transpulmonary thermodilution technique.

"We plan to launch the PulsioFlex Monitoring System and PiCCO Module in the United States later this month. This will expand the portfolio of ICU solutions that we offer medical centers through our Advanced Patient Monitoring Business Area," said Greg Master, President, Acute Care Therapies USA, at Getinge. "With FDA clearance of this advanced bedside monitoring system, we now have our own advanced hemodynamic patient monitoring system to offer hospitals to help their staff make more informed clinical decisions and provide high-quality care for critically ill patients. Until now, the PiCCO Module was available only for use with patient monitoring systems from GE Healthcare and Philips Medical Systems."

Features of PulsioFlex Monitoring System
The PulsioFlex Monitoring System is a flexible platform for advanced hemodynamic monitoring that can be adapted to each patient's individual needs at any time. It also can be configured to support HIPAA compliance. The PulsioFlex Monitoring System has a modular setup that easily allows for future technology integration. Additionally, with the PulsioFlex monitor, the number of PiCCO parameters has been expanded by four – from nine to 13.

Two of the additional parameters allow for expanded assessment of pulmonary edema beyond the extravascular lung water index (ELWI) parameter:

• Pulmonary Vascular Permeability Index (PVPI) – Distinguishes between cardiogenic and permeability caused pulmonary edema
• Intrathoracic Blood Volume (ITBV) – Shown to be consistently 25 percent higher than Global End-Diastolic Volume in a clinical study using double-indicator dilution technology to measure ITBV and extravascular lung water (EVLW)ⁱ

Two of the additional PiCCO parameters expand capabilities for contractility monitoring:

• Global Ejection Fraction (GEF) – Offers a complete picture of the overall cardiac contractility
• Cardiac Power Output/Cardiac Power Index (CPO/CPI) – Shown in clinical studies to be the strongest independent predictor of hospital mortality in patients with cardiogenic shock^ii,iii

PulsioFlex includes OrganView, a novel graphical overview that uses a traffic light system to identify out-of-range values, and three different calculated volume test methods – Fluid Challenge, Passive Leg Raising and End Expiratory Occlusion – to help determine the patient's fluid responsiveness.

The PulsioFlex monitoring system allows real-time dynamic monitoring with a dedicated PiCCO module, which is the only system in the U.S. today that continuously measures cardiac and pulmonary values such as CPI, ELWI and GEDI for the critically ill patient.

About Getinge
Getinge is a global provider of innovative solutions for operating rooms, intensive care units, sterilization departments and for life science companies and institutions. Based on our first-hand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving the every-day life for people, today and tomorrow.

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i} Sakka SG et al. Assessment of cardiac preload and extravascular lung water by single transpulmonary thermodilution. Intensive Care Med. 2000;26(2):180-187.
ⁱⁱ Mendoza DD, Cooper HA and Panza JA. Cardiac power output predicts mortality across a broad spectrum of patients with acute cardiac disease. Am Heart J. 2007;153(3):366-70.
ⁱⁱⁱ Fincke R et al. Cardiac power is the strongest haemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004;44(2):340-8.

SOURCE Getinge