Directed Systems has announced a strategic alliance with Arcos to manufacture and supply its health technology product called Hypotension Decision Assist (HDA) to hospitals across the USA.
The product is designed to help clinicians manage blood pressure and the cardiovascular system in patients undergoing anaesthesia during surgical procedures. The novel technology has been designed as an adjunct to patient monitors used in operating rooms to help keep patients stable and avoid inter-operative hypotension (IOH) episodes that are associated with negative outcomes for patients, including increased risk of mortality and organ damage. The technology has been prioritised for launch in the USA following its receipt of the Food and Drug Administration (FDA) 510(k) clearance of Hypotension Decision Assist (HDA) in November 2019.
Hospital operating rooms are highly pressurised environments for anaesthesiologists charged to keep patients safe and stable when undergoing surgery. IOH episodes are common 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.
Existing available patient monitors do not provide the specific clinical decision support information to the anaesthesiologist that HDA provides in the operating room. Even short periods of IOH during surgery, where it falls below certain patient specific critical thresholds, may increase the risks of organ injury and other adverse outcomes for the patient. A 2014 study of almost 17,000 anaesthetic records revealed that over a quarter (26%) of the surgical patients involved had a peri-operative systolic blood pressure of less than 80 mmHg for more than five minutes. The threshold for myocardial injury is an operative Mean Arterial Pressure (MAP) less than 65mmHg. The threshold for renal injury may be higher, possibly nearer 75 mmHg. A few minutes of a MAP less than 55mmHg is associated with Acute Kidney Injury and Myocardial Injury and has been demonstrated to increase markedly with prolonged intra-operative hypotension.
Mark Leaning, CEO and founder of Directed Systems, said: “We at Directed Systems Limited are delighted to announce that we have taken the decision to put our faith in Arcos to deliver our novel and newly launched and FDA 510(k) cleared Hypotension Decision Assist (HDA) to hospitals across the USA. We already have a trusted and proven relationship with Arcos in delivering their technology to the UK and we are now delighted to reciprocate and work with them to deliver our novel technology to help support US hospitals and ultimately support anaesthesiologists to deliver enhanced care for patients across North America especially at this challenging time during the pandemic that has put extreme pressure on our healthcare systems. More than ever before, we as medical technologists need to work together with our clinical colleagues to help deliver better patient care."
Hypotension Decision Assist (HDA), is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically rated touch-screen computer that supports anaesthetists by providing intuitive visualisation on a single display of at-a-glance time critical information about emerging critical cardiovascular situations to help better manage hypotension during surgery in the operating room.
Chris Meador, CEO and co-founder of Arcos, added: “We are delighted that the innovative UK based and international company Directed Systems Limited is leading the charge against the risks of hypotension in surgery and has chosen us to manufacture, fit and deliver their hypotension clinical decision support tool for clinicians across the USA as its priority launch country where needs are great. Arcos has been developing and supplying clinical decision support products in the U.S. market for the last seven years and we are enthusiastic about bringing Directed Systems Limited’s novel and much needed technology to U.S. patients.”
Directed Systems hopes that this strategic alliance with Arcos will provide the infrastructure to implement and expand its footprint in the USA. Pending CE mark approval from the European Union and UK-CA marking from UK regulatory authorities, the EU and UK launch of HDA is expected later in 2021, with a phased local country launch approach across the European countries including Germany, France, Spain, Italy, the UK and then beyond to the remaining EU markets.
