Directed Systems boosts fight against hypotension during surgery
Cambridge company Directed Systems Limited looks poised for a boom in the US with its newly-upgraded technology designed to manage hypotension – dangerously low blood pressure – during surgery.
It has unveiled a new version of – and FDA 510(k) clearance for – its operating room solution Hypotension Decision Assist (HDA)® which is now available for sale in the US.
While the HDA is currently not for sale in Europe, Directed Systems is in the process of resolving that issue.
It is conducting a clinical investigation with collaborative partners at Queen Elizabeth Hospital Birmingham and this will form part of a submission for EU and UK regulatory approval. EU and UK market launches of HDA are expected in 2022.
The FDA clearance, meanwhile, allows the HDA)® software to be installed on an Advantech medical tablet with networking capabilities. The new version is smaller, lighter, with a more portable medical grade tablet and new remote capabilities that provide case review summaries, remote software upgrade capability and advanced performance metrics via a cloud-based data analytics and reporting platform.
The solution is installed on a medical grade touch-screen tablet and supports anaesthesiologists by providing intuitive visualisation on a single display of at-a-glance time critical information about emerging critical cardiovascular situations in the operating room.
It is indicated for use to help anaesthetists to manage the blood pressure, haemodynamic stability and cardiovascular system of patients undergoing surgery and counter hypotensive episodes and cumulative hypotension during surgery.
With HDA on a smaller, lighter, portable medical grade tablet, software upgrades can now be installed remotely to further assist medical professionals to easily obtain enhancements and new functionality that improve the overall HDA user experience.
The new HDA-OR2 also enables Hypotension Case Review to be revised at the end of each surgical procedure – providing a complete case review summary that visualises any hypotensive episodes, total cumulative hypotension and trends of several additional haemodynamic parameters.
It is scrollable and zoomable for time specific and detailed analysis. Its improved functionality now has additional networking capabilities, able to access cloud based HDA analytics and reporting platform for in depth analysis of individual and overall caseload performance metrics.
Episodes of inter-operative hypotension (IOH) are common occurrences in the operating room and are known to occur in over one quarter of patients undergoing non-cardiac surgery at any time.
IOH can cause poor outcomes – even death – especially in high-risk patients undergoing surgery and occur when it falls below certain patient specific critical thresholds and may increase the risks of organ injury and other adverse outcomes.
Dr Mark Leaning CEO and founder of Directed Systems, said: “We are delighted that the new Hypotension Decision Assist (HDA-OR2)™ has achieved FDA 510(k) clearance allowing it to be provided to anaesthesiologists and hospitals across the United States to help better manage hypotension during surgery.
“We know that the COVID pandemic has massively interrupted hospitals in their ability to provide surgical services and recognise that there is an ambition now to clear surgical waitlists.
“We look forward to helping support US hospitals and anaesthesiologists to deliver enhanced care for their surgical patients as they aim to reduce surgical waitlists and return to a more normal provision of surgical services for their patient communities.”