An interview with Steve Parker, CEO, Creavo Medical Technologies, conducted by April Cashin-Garbutt, MA (Cantab)
What was the vision behind Vitalscan?
In the UK, more than 5% of emergency department visits and up to 40% of emergency admissions are as a direct result of chest pain. Chest pain-related emergency hospital admissions not only create a vast economic burden on healthcare services but also cause huge disruption to inpatient care.
Currently hospitals operate a ‘rule in’ diagnosis or triage process which is hugely time consuming, requiring a combination of medical history, physical examination, ECG and blood tests including measurement of cardiac biomarkers (most commonly cardiac troponin, released when there is physical damage to the heart muscle itself). This combination can take many hours and may still be inconclusive.
A negative troponin test cannot ‘rule out’ unstable angina, or an early evolving heart attack before any muscle damage has occurred (because troponin only appears in the blood several hours after the onset of heart damage).
Equally, a normal ECG does not mean that heart damage is not taking place merely that the damage is such that it cannot be seen on the recording. As a result, patients may either be discharged despite having a high risk of heart damage or even death due to acute coronary syndromes or kept in hospital taking up valuable bed space, staff time and resources when these are not needed.
Due to this complex, yet often inconclusive triage process, the clinical need was clear – accurate ‘rule out’ would deliver significant benefits. This is what inspired the development of Vitalscan.
How does the device use quantum imaging to rule out serious cardiac conditions?
We have applied advanced quantum principles to create Vitalscan. It uses magnetocardiography (MCG) to measure, display and store electromagnetic fluctuations caused by heart activity.
The device produces a trace, numerical data and a 2D visual magnetic field map of the heart to aid healthcare professionals in the triage of patients presenting with chest pain. Cells in the heart that lack oxygen (ischaemic) or are dying distort the data points and parameters picked up by the device, this can then clearly be seen in the resulting trace and map.
Vitalscan performs a simple and non-invasive scan at the patient’s bedside in around 3-5 minutes. The device is designed to be used alongside other tests and support health professionals’ clinical judgement to identify those patients who are not suffering from ischemic heart disease.
Which conditions can the device help to rule out?
Vitalscan can help doctors to rule out cardiac conditions, such as a heart attack or other serious heart problems. Patients without a serious ischemic cardiac condition can be identified quickly, significantly saving hospitals time and resources.
How do you ensure there are no false negatives?
MCG is a technique that is proven to accurately detect the absence of many types of cardiac conditions. It measures the magnetic fields produced by electrical activity in the heart using extremely sensitive detectors. These signals are a million times smaller than those generated by the earth.
Initial clinical studies would indicate that the ‘rule out’ of non-cardiac patients can be achieved with a high specificity at near 100% negative predictive value. This means that Vitalscan has a near 100% accuracy rate.
What stage of development is Vitalscan currently at?
Vitalscan has been developed specifically for clinical research. Our learnings from the research will be implemented in our commercially-ready device which is planned for launch next year. Currently the device is being trialled at four major hospitals across the UK in Bristol, Nottingham, Leicester and Sheffield with further studies planned across Europe and in the United States.
What feedback have you received from trials so far and what impact do you hope the device will have on A&E departments?
Vitalscan has had positive feedback so far both from users and patients at the hospitals where it is being trialled. Users are pleased with how simple and quick it is to operate and patients like the fact that it’s a passive, non-invasive test, bringing relaxation to the A&E process which for most people can be very stressful.
It is estimated that up to 75% of patients who present at the emergency department with chest pain don’t actually have a serious cardiac condition, but will still have to complete the lengthy triage process. Being able to rule out these patients early on and removing the need for them to go through the process will free up the time and resources of A&E staff to allow them to treat the patients with more serious cardiac conditions and all other patients much quicker.
How much does Vitalscan cost and what evidence do you have to show that it could save the NHS money?
When Vitalscan goes to market next year it is likely to cost no more than £100,000 per device. When a cardiac patient is put through the full triage process it usually costs between £1,000 and £2,000 per patient. Based on this and the numbers of emergency cardiac admissions each year, it is estimated that Vitalscan could save the NHS as much as £200 million a year if it were to be rolled out across every A&E department in the country.
How long would it take hospitals to see a return on investment?
Depending on the volume of chest pain patients coming to an individual A&E department, we expect hospitals to see a return on investment in just six to eight weeks.
What do you think the future holds for diagnosing serious cardiac conditions?
There is a huge amount of research focussed on the better and earlier detection of those patients who are suffering from an acute heart condition such as a heart attack and this can only be good for the patient who receives better treatment quicker.
For patients who ultimately do not have a serious problem the clinical triage process becomes more complex with the goal of higher and higher sensitivity giving the potential for more false positive results. This results in a much stronger need for a device such as Vitalscan that can help identify those non-serious patients earlier and remove the need for the ever-increasing number of diagnostic tests.
Does Creavo Medical Technologies plan to release any devices to rule out other medical conditions?
Our focus right now is very much on cardiology and the detection of acute cardiovascular disease. However, the core technology has been proven to help rule out conditions in other organs as well, so we are open to exploring other opportunities.
Where can readers find more information?
About Steve Parker
With Steve at the helm, Creavo Medical Technologies has grown rapidly over the last three years. He was the driving force behind securing two successful rounds of investment which have been essential in bringing this exciting technology to life.
Steve comes from a strong leadership background. He has held a series of senior roles in international medical device companies over a period of 40 years. He started his career in engineering, marketing and sales roles with Marquette Electronics (later to become part of GE Medical Systems) and various national management roles at St Jude Medical Inc. (not part of Abbott Laboratories).
Steve also served as European Director of Sales and Marketing for Vasomedical Inc. and Managing Director of i-STAT Ltd, holding responsibility for all European operations. Most recently, he was Senior Director, International Commercial Operations, at Abbott Laboratories with divisional commercial responsibility for all markets outside of North America.
At Creavo Medical Technologies, Steve has built an experienced management team which includes specialists from a range of disciplines, including fundamental and clinical research, medical technology commercialisation, manufacturing and global regulatory and clinical strategy to ensure further successful growth.