H2020 Fast-track to Innovation

The Project

Cardiovascular disease (CVD) describes diseases of blood vessels or the heart and includes coronary heart disease, stroke, peripheral arterial disease, and aortic disease. The blood flow to the heart, the brain or other parts of the body can be negatively impacted by blockages (e.g. a thrombus) or narrowing (stenosis). Due to ageing populations in the developed world and adverse lifestyle factors for many, CVD is on the rise. CVD accounts for 40% of deaths in the EU and costs the EU economy over €190 billion a year. Imaging technologies are crucial for thorough diagnosis and accurate optimal treatment planning of complex vascular diseases and associated surgery. Current gold-standard for three-dimensional vascular imaging is CT angiography, an imaging technology that is based on X-rays and a contrast agent that may harm the patient´s renal function over time.

Our mission is to make vascular imaging more affordable and safer for the patient through the innovative tomographic ultrasound solution PIUR tUS. PIUR tUS extends regular ultrasound devices with a tomography function so physicians can produce three-dimensional diagnostic information without the side effects current imaging technologies may introduce. Optimized usability and a high degree of automatization improves diagnostic workflows and communication between physicians while eliminating the patient´s exposure to radiation and harmful contrast agents for several indications.

In this project, we want to develop a second generation of PIUR tUS, making it mobile, more affordable, and develop additional clinical applications.

Project Objectives

Software

Development of new clinical applications

We will develop new software solutions that provide a larger portfolio of tools for visualization and data analysis. We we will leverage Deep Learning algorithms to automize most of our quantification tools.

Mobile hardware design

The hardware of the 2nd Generation PIUR tUS device will be mobile and available with an optional cart. This allows easier transportation in-between rooms and is perfectly suited for institutions with multiple-scan rooms and POC.

Hardware
Sensor

Development of innovative sensor tracking solution

A wireless, sensor-based tracking unit will increase ease-of-use, flexibility, and reduce costs. It does not require external references and is a cost-effective solution to upgrade any ultrasound with 3D-capabilities.

Four clinical multi-center studies

We will perform four clinical studies with 200 participants each. The studies include „Treatment planning for peripheral arterial disease (PAD)“, „Conduit mapping for coronary and peripheral bypass surgery“, „Detection of complications following surgically created arterio-venous fistula for haemodialysis“, and „Assessment of Carotid artery disease by measurement of Carotid Plaque Volume (CPV) for determination of surgical benefit“

ClinicalStudies

The Consortium

Independent Vascular Services Limited

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Independent Vascular Services (IVS) specialises in provision of high quality, comprehensive vascular services to the NHS and Private sector with its team of highly talented and experienced clinical vascular scientists. IVS is the largest provider of specialist vascular ultrasound services in Europe, performing over 70,000 vascular investigations every year. IVS currently provide services to over ten NHS hospitals covering an estimated population of over 4 million people. It is the first independently accredited vascular service in the UK.

IVS will consult the project team during the development and commercialisation of piur tUS, manage clinical studies at UHSM, and distribute the system in the UK. Additionally, they will train customers on 3D ultrasound image acquisition and analysis after purchasing the piur tUS device.

Website: http://www.ivs-online.co.uk

piur imaging GmbH

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piur imaging GmbH develops tomographic ultrasound solutions for the safe and cost-effective image diagnostics of vascular diseases. Our expertise lies in medical devices, 3D imaging and image diagnostics. Our vision is to create innovative diagnostic solutions for the healthcare market. Since the incorporation of Piur Imaging GmbH in 2014, we have attracted seed funding which has been used in the development and certification of a 3D freehand tomographic ultrasound technology, Generation 1 PIUR tUS system.

Our mission is to improve vascular image diagnostics “We make vascular imaging safer and more affordable through innovative tomographic ultrasound solutions”

Website: http://www.piurimaging.com

ImFusion GmbH

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ImFusion is a Munich based R&D company that specialises in medical 3D image processing. ImFusion offers consulting, research and development in advanced medical image computing technologies and computer vision. Our strong academic track record is paired with the expertise to create highly efficient product implementations on today’s parallel multi-core and GPU architectures.

We aim at advancing the state of the art by developing superior medical image computing technology. At the same time, this technology shall be well packaged and usable by both engineers and researchers, as well as clincians.

ImFusion complex image processing algorithms will form an important basis for both the piur Sensor Tracking technology and the automatic segmentation algorithms.

Website: http://www.imfusion.de

ACMIT Gmbh

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Since 2010 ACMIT Gmbh (partly under their former company name „Integrated Microsystems Austria GmbH“) is operating a competence center for medical technology development (Austrian Center for Medical Innovation and Technology), dealing with development of new medical technology in the area of minimally invasive procedures.

Website: http://www.acmit.at

University of Manchester, Institute of Cardio-Vascular Science

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The Institute of Cardiovascular Sciences is comprised of nearly 40 principal investigators made up of both clinicians and basic scientists with national and international reputations in their respective fields.

ICVS performs a wide spectrum of research spanning clinical trials, whole organs, tissues, cells and single molecule studies. Their success and strategy was recognised internationally, with 75% of their Cardiovascular researchers rated as world leading and internationally excellent.

Website: http://www.manchester.ac.uk

3rd Party Partners

Institute for Medical Systems (IMT) - OVGU

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Institute for Medical Systems (IMT), Faculty of Electrical Engineering and Information Technologies, Otto von Guericke University Magdeburg
Engineering, natural sciences and medicine are the main fields of expertise of the OVGU Magdeburg. Medical engineering is one of the four research focuses of the university.

The IMT research team has longstanding expertise in the fields of medical device tracking, signal processing, electronics development, and sensor design. Within their own technical labs, the IMT has access to a variety of devices which are required during the development and evaluations process such as clinical ultrasound (US), MRI and X-ray devices, different commercial tracking systems, and rapid prototyping machines.

Within the project OVGU will provide development support for the sensor technology and accuracy and performance testing of the system and components.

Website: http://inka-md.de/

Abstracts Clinical Studies

Chief Investigator – Prof Charles McCollum
Principal Investigator – Mr Steven Rogers

Contrast enhanced tomographic (3D) ultrasound assessment of the crural arteries and plantar arch in peripheral arterial disease

Peripheral arterial disease (PAD) describes the build-up of atherosclerotic plaque within the arteries of the legs which, when it becomes flow-limiting, can cause a range of symptoms from intermittent claudication through to critical limb ischaemia. In severe cases, this can require catheter-based revascularisation using angioplasty and stenting, or arterial bypass surgery. The first line tool in the diagnosis of PAD is duplex ultrasound, however, this has limitations. To aid surgical planning, surgeons still rely on alternative angiographic imaging, which poses a risk to the patient. Contrast Enhanced Tomographic Ultrasound (CEtUS) is a novel imaging modality that negates the risks of alternative angiographic imaging and may play a role in PAD treatment planning.

Contrast Enhanced tUS to Measure Carotid Plaque Volume

Stroke is the leading cause of disability in the UK, affecting over 150 000 people/year. Carotid artery disease (CAD) accounts for 30% of ischaemic strokes; even though we now know that most strokes are caused by atheroembolism. The indication to operate on CAD is still the severity of the stenosis. Current European Society of Vascular Surgery (ESVS) guidelines, based on 4 major trials (ECST, NASCET, ACST, ACAS), recommend carotid endarterectomy (CEA) for symptomatic severe carotid stenoses. In asymptomatic patients, the severity of carotid stenosis is a poor predictor of stroke risk as asymptomatic patients with >70% carotid stenosis have an ipsilateral stroke risk of under 2%/year. The fact severe atherosclerotic arterial disease may not cause stenosis has been known for many years. Research has reported that arteries undergo outward remodelling to preserve luminal diameter, with stenosis only occurring once 40% of the internal elastic lamina is occupied by plaque. We recently completed a study recruiting 220 patients undergoing CEA. Remarkably Carotid Plaque Volume (CPV) in patients undergoing CEA within four weeks of symptoms of TIA or stroke was almost double of that seen in asymptomatic patients. Mean CPV in the symptomatic group was 1.01cm3 compared with 0.78cm3 in those with no symptoms (p=0.003) demonstrating a clear potential link between CPV and cerebrovascular symptoms in CAD. 3D ultrasound has been widely used to assess plaque volume and been proven to be reliable with low observer variability but is time consuming. Contrast enhanced ultrasound is proven to be safe when used in acute stroke and several studies demonstrate improved visualisation of CAD. We believe that this improved visualisation of CAD will enable us to better measure CPV and potentially develop automatic analysis of CPV to make it clinically utile.

Comparison of standard duplex ultrasound imaging to tUS for the evaluation of potential autologous bypass grafts for coronary and vascular surgery

Coronary artery bypass grafting (CABG) is required when there is significant and profound cardiac ischemia. Peripheral arterial occlusive disease bypass grafting (PBG) is required when there is significant and profound ischaemia of the lower limb. CABG and PBG is necessary in coronary heart disease to restore adequate blood supply to the heart muscle and in peripheral arterial disease to restore adequate blood supply to the muscles of the lower limb. The success of CABG and PBG can be determined by the availability of suitable veins being harvested. At present, surgeons utilise standard 2D duplex ultrasound mapping to select the best vessel for surgery. This relies on high levels of trust between the ultrasound practitioner and surgeon that the practitioner is identifying the best vessel. Tomographic ultrasound (tUS) allows the surgeons themselves to visualise and identify the optimum vessel candidate quickly. This study assesses the utility of tomographic ultrasound for this purpose, comparing tUS to standard duplex but also the harvested vein.

Tomographic ultrasound for the detection of complications following surgically created arterio-venous fistula for haemodialysis

Two percent of patients with chronic kidney disease (CKD) will progress to kidney failure and more than half the total cost to the UK National Health Service for CKD is spent on renal replacement therapy (RRT) each year. In 2005, there were over forty thousand patients on RRT in the UK, which was increasing by 5% each year. Dialysis, using a surgically created arterio-venous fistula, is the foremost method of RRT with in hospital haemodialysis (HD) costing over thirty-five thousand pounds, per patient, each year. The main cause of fistula failure is through intimal hyperplasia resulting in a flow-limiting stenosis and therefore, poor vascular access for HD and is the largest cause of morbidity in renal failure patients. Tomographic ultrasound (tUS) may play a role in determining the stenosis location and size, currently confirmed by alternative angiographic imaging, avoiding the use of unnecessary radiation and nephrotoxic contrast; identifying clearly patients that require intervention. This study will compare the cost effectiveness and accuracy of tUS at identifying the target stenosis when compared to angiograms.