Project: Novel Catheter Tracking System
Every year cardiovascular disease (CVD) causes over 1.9 million deaths in the European Union (EU), representing the leading cause of mortality. In most of the cases the treatment consists in a catheter based surgery, with angioplasty, ablation, and stenting being the most common procedures [1]. Aging and a growing population will constantly increase the number of treatments with e.g. 450’000 aortic stent-grafts will be implanted in Europe [2] and 650’000 heart coronary stents in the US [3] in 2016._x000D__x000D_When inserted in the body the catheter needs to be continuously visualized during surgery. The visualization is performed in 90% of the procedures with contrast dye and x-ray imaging, not without drawbacks on the patient: 1) contrast dye causes in many patients (from 4% in the general population to 25% in patients with diabetes or hypertension [4]) an impairment of the renal function often resulting in the need for dialysis and 2) x-rays are harmful for patients and doctors as the x-rays carries the risk of triggering cancer [5]._x000D__x000D_THERE IS THUS AN UNMET NEED FOR TRACKING CATHETERS WITHOUT USING CONTRAST DYE AND IONISING RADIATIONS_x000D__x000D_CO GOAL OF NoCaTS_x000D_The overarching aim of this project is to develop an innovative catheter with an integrated tracking system based on the novel “Trackcath” technology that has been recently patented by the CO participant M7._x000D__x000D_“Trackcath” is unique as it is able to track anatomical landmarks that the surgeon use to navigate the catheter, e.g. side branches, localized by measuring the flow patter in their vicinity (cfr. Annex). It is composed of different hardware and software components that will be developed or optimized and integrated as reflected in the work plan of the proposed project:_x000D_- A disposable catheter equipped with flow sensors (Wp1,2)_x000D_- A blood flow measurement unit (Wp3)._x000D_- An intuitive graphical user interface that visualizes the position of the catheter within the vasculature (Wp4)._x000D__x000D_For the development of this highly innovative catheter with a great market potential , we have formed a multi-disciplinary consortium of 2 R&D-driven SMEs with IP protected knowledge (M7, CP), a leading industrial sensor manufacturer (IST) and 3 reknown research organisations (USZ, ZHAW and Acreo) from Switzerland and Sweden. Each of our Ps provides a different component and a specific yet complementary expertise required to develop, validate and bring this new medical device to the market within 2 years after the project end. Being a medical device with medium-high level of risk (Class IIb), animal and human trials will be performed in order to fully comply with current regulations_x000D__x000D_- M7 will provide the patented concept of the Trackcath technology and develop the flow measuring system and the graphical user interface_x000D_- Cathprint is proprietary of a unique technology that allows the wiring and bonding of sensor in an automatic and batched way_x000D_- Acreo will design a novel sensor manufacturing process using hybrid printing technologies_x000D_- IST will develop the micro-sensors and perform the process development_x000D_- ZHAW will contribute with its expertise in the design of electronics and software architecture_x000D_- The University hospital of Zürich (USZ) with his team of top level vascular surgeons will prepare and perform the in vivo studies and ensure clinical, surgical and regulatory compliance_x000D__x000D_ECONOMIC AND HEALTHCARE IMPACT_x000D_“The development of medical devices may deliver innovative solutions for diagnosis, prevention, treatment […] that could contribute to mitigating the shortage of healthcare professionals and could contribute to addressing the sustainability of healthcare system […] Innovation in medical devices should contribute to the continued improvement of patient and user safety”_x000D_COUNCIL OF EUROPEAN UNION, 6June2011_x000D__x000D_In line with this EU policy and existing EC directives, the NoCaTS project will:_x000D_- In the short term, eliminate the risk of contrast induced nephropaty (CIN). Estimated [4] as 20,000USD the cost of the CIN, due to prolonged hospitalization and treatments_x000D_-In the medium term, Trackcath will lower the x-ray delivered to patient and surgeons_x000D__x000D_The Trackcath based catheter system represents a great opportunity to advance the state-of-the-art in CVD treatment and a huge potential for commercialisation for the project Ps while providing a better solution to surgeons and patients and reducing health care costs_x000D__x000D_The NoCaTS was accepted under the Swiss-Swedish Iniative for R&D Calls as Eurostars project._x000D__x000D_[1]European Cardiovascular Disease Statistics 2012. European Heart Network_x000D_[2] Greenhalgh S., Charing Cross conference 2011_x000D_[3]Auerbach DI, et al. Hospital Stays with Cardiac Stents,2009:Statistical Brief_x000D_[4]The Impact of Diabetes Mellitus and Renal Insufficiency on the Outcome of Endovascular Abdominal Aortic Aneurysm Repair. Markovic et. al. Perspect. vasc. surg. endovasc. ther.2010 _x000D_[5]Breast cancer mortality after diagnostic radiography. Doody MM, Spine. 15,2000.
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Acronym
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NoCaTS
(Reference Number: 8212)
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Duration
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02/09/2013 - 31/08/2016
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Project Topic
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Aim of this project is to design and produce a novel tracking system for catheters used in cardiovascular procedures. The use of the novel tracking system will reduce the need of the contrast dye and x-ray during cardiovascular procedures.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 10
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Project partner
