Doctors at St George’s Hospital in London, UK are set to become the first within the UK National Health Service (NHS) to begin using Oxford Heartbeat’s PreSize Neurovascular technology following its receipt of CE-mark certification earlier this year.
A pilot study will see several hospitals across the UK using PreSize, as well as giving Oxford Heartbeat the opportunity to collect “crucial evidence” on the medical software’s effectiveness, the company states in a press release. The launch of this technology at St George’s Hospital marks the first phase of a pilot across a number of NHS trusts.
“I am very excited about trialling PreSize Neurovascular at St George’s Hospital. It has the potential to vastly improve the safety, efficacy and cost-effectiveness of flow-diverter treatments,” said Jeremy Madigan (St George’s Hospital, London, UK). “Knowing in advance the absolute correct size of device provides peace of mind for the operator, leads to a quicker and smoother procedure, and reduces overall stress for the whole team. It will also be a very useful tool to explain procedures to our patients in clinic and, through thorough data collection and feedback, should ultimately inform improved stent design and technology.”
This study is being fully funded by the Artificial Intelligence (AI) in Health and Care Award 2020—created by a number of UK government bodies, including NHSX and the National Institute for Health and Care Research (NIHR), in an effort to further integration of AI and other digital solutions that will drive innovation within the NHS.
As a recipient of this award, Oxford Heartbeat has been recognised as a company developing a promising AI solution that could “revolutionise” patient care, the release also notes.
Oxford Heartbeat’s innovative PreSize Neurovascular software aims to “drastically reduce” risks associated with minimally invasive brain aneurysm treatments involving placement of a flow diverter by enabling clinicians to plan and rehearse stenting procedures in a safe, virtual environment that accurately represents the anatomy in front of them and recommends a best-fit stent for that specific patient. This more individualised approach is ultimately intended to optimise surgical choices, improve patient outcomes and reduce hospital resource wastage.
“We always put the needs of patients and the clinical community first,” said Katerina Spranger, CEO of Oxford Heartbeat. “PreSize drives social change by bringing direct benefits to surgeons and patients while, for hospitals, we are enabling the improvement of standards for delivery of care. We estimate that PreSize will benefit thousands of patients in the UK annually. Due to trends of ageing population, PreSize has the potential to bring benefits to an ever-increasing number of patients in the future.”
In March 2020, Oxford Heartbeat announced that PreSize Neurovascular had been awarded a CE mark, meaning it is certified as having met the health, safety and environmental protection standards for products sold within the European Economic Area (EEA). At the same time, the company also announced receipt of a full ISO13885:2016 certification as a medical device firm from the British Standards Institution (BSI).
This CE mark was granted in light of a retrospective validation study carried out in collaboration with four interventional neuroradiology centres in the UK. Based on a retrospective analysis of preoperative and postoperative data from 65 brain-stenting patients, PreSize was able to successfully predict the final deployed stent configuration within the patients’ anatomies, with an “excellent” average accuracy of 96.75%—a rate that, according to Oxford Heartbeat, significantly exceeds clinical expectations of 90% and makes PreSize “one of the safest planning tools anywhere for clinicians performing stenting”.