Directed Systems joins force with Arcos, Inc. to supply their innovative clinical decision support technology to US hospitals

Directed Systems joins force with Arcos, Inc. to supply their innovative clinical decision support technology to US hospitals that addresses common problem of hypotension during surgery as it explores international post-Brexit sales opportunities in the USA

Cambridge, UK – 17th December 2020. Today, Directed Systems Ltd, announced a strategic alliance with Arcos, Inc. to manufacture and supply its innovative health technology product called Hypotension Decision Assist (HDA)TM to hospitals across the USA; designed to help clinicians manage blood pressure and the cardiovascular system in patients undergoing anesthesia 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 U.S. Food and Drug Administration (FDA) 510(k) clearance of Hypotension Decision Assist (HDA)TM in November 2019.

This business alliance is a positive step for the British company as an example of a UK health technology company exploring opportunities beyond its 1 January 2021 Brexit departure from its European trading partner the European Union, as it now makes available its innovative HDA technology in the United States, the largest market in the world for healthcare.    

Hospital operating rooms are highly pressurised environments for anaesthesiologists charged to keep patients safe and stable when undergoing surgery. However, IOH episodes are common and are known to occur in over one quarter of patients undergoing non-cardiac surgery at any time.1 IOH can cause poor outcomes, even death – especially in high-risk patients undergoing surgery.2 Existing available patient monitors do not provide the specific clinical decision support information to the anesthesiologist 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.1 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 < 80 mmHg for > 5 minutes.2 The threshold for myocardial injury is an operative Mean Arterial Pressure (MAP) < 65mmHg. The threshold for renal injury may be higher, possibly nearer 75 mmHg. A few minutes of a MAP < 55mmHg is associated with Acute Kidney Injury and Myocardial Injury and has been demonstrated to increase markedly with prolonged intra-operative hypotension.1

“We at Directed Systems Limited are delighted to announce that we have taken the decision to put our faith in Arcos, Inc. to deliver our novel and newly launched and FDA 510(k) cleared Hypotension Decision Assist (HDA)TM to hospitals across the USA” explained Mark Leaning PhD, CEO and Founder of Directed Systems Limited. “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)TM, is a uniquely designed 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.

 “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” added Chris Meador, CEO and Co-Founder of Arcos.

Directed Systems Limited hopes that this strategic alliance with Arcos, Inc will provide the infrastructure to implement and expand a successful 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.

Note to Editors:

About Directed Systems Limited Directed Systems Limited is a fast-moving medical software and data science company based in Cambridge, England, with an office in Austin, Texas, USA. The company provides software that incorporates smart proprietary algorithms and data science to analyse, visualise and interpret real-time physiological signals. This helps clinicians manage blood pressure and the cardiovascular system in patients undergoing anaesthesia during surgical procedures. For further information, visit: https://directedsystems.com/ 

About Arcos, Inc. Arcos, Inc. develops and provides clinical decision support tools to empower health care workers in critical care situations, improving patient outcomes and reducing health care costs. Arcos’ products include Vent Navigator™, Blood Navigator™ and Burn Navigator®. Arcos is headquartered in Missouri City, Texas, USA. For more information, visit ArcosMedical.com

About Hypotension Decision Assist (HDA)TM HDA is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their invasive arterial pressure is being continuously monitored by a multi-parameter operating room patient monitor. It is indicated for use to assist anaesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery. The U.S. Food and Drug Administration (FDA) 510(k) clearance of a US version of Hypotension Decision Assist (HDA)TM was received in November 2019.

For media/journalists:

For further information, on Directed Systems Limited, please contact: Roseann Ward, Ward PR Limited Email: roseann.ward@wardpr.co.uk Mobile/Cell: + 44 (0) 7932 798151 

For further information, on Arcos Inc, please contact: Jennifer Kinney, Arcos, Inc. Email: j.kinney@arcosmedical.com

References

1. Walsh M. Kurz A. Turan A. et al. relationship between Interoperative Mean Arterial Pressure and Clinical Outcomes after Noncardiac Surgery. Anesthesiology 2013; 119 (3);507-505. Doi:10.1097/ALN.0b013e3182a10e26. 

2. Nair et al. “Anesthesia information management system-based near real-time decision support to manage intraoperative hypotension and hypertension.” Anesth Analg 2014; 118: 206–214