Advanced cardiac monitoring
The situation
More than 900,000 open heart surgeries are conducted each year in the US and EU. While this number has decreased in recent years, the complexity of the patients requiring surgery has increased.
The challenge
Available techniques for monitoring the function of the heart after surgery tend to be either inaccurate, episodic echo-cardiography or involve a high risk to the patient.
The solution
Real-time heart function data allows for correct medication, early detection of complications and
improved patient recovery, reducing cost for healthcare systems.
“It is additional information that could reveal problems or complications faster than other parameters which have to be detected after a problem is suspected, e.g. a TEE is performed. I could imagine that a problem could be signaled at an earlier stage.”
German cardiothoracic surgeon
Our technology
1. Smart lead
Temporary pace leads are used routinely during cardiac surgery, all over the world. Cardiaccs' smart lead has an integrated sensor for monitoring cardiac function.
2. Easy to use
Cardiaccs' combined sensor and pace lead is placed and removed in the same way as standard temporary pace leads.
3. Vital data
Cardiaccs' lead has an embedded accelerometer sensor that measures the velocity of each cardiac contraction. This is a vital parameter for monitoring the cardiac function.
“The benefits are that you might be able to nip a problem in the bud. Like ischemia and maybe rhythm issues.”
US cardiothoracic surgeon
Cardiaccs
Story
Cardiaccs was founded in 2009 by
Prof. Erik Fosse as a result of 8 years of research and development by the Intervention Centre at Oslo University Hospital in cooperation with Buskerud and Vestfold University College. Since February 2016, the company has been
ISO 13485 certified for design and development of medical devices.
Vision
Cardiovascular related diseases are
the leading cause of hospitalization and death worldwide, and there is an increase of patients with complex cases where open heart surgeries are required. Cardiaccs wants to cover the urgent unmet need for better cardiac monitoring to reduce morbidity and mortality in this patient group.
Technology
Cardiaccs provides technology for measuring myocardial contractility, a vital parameter for monitoring of the cardiac function. With a continuous and accurate monitoring of the cardiac function, intra- and post-operative complications can be avoided, before a patient becomes critical.
Quality
Certified
Cardiaccs is ISO 13485 certified for the design, development and manufacture of active, non-implantable cardiac monitoring devices and associated software. Quality has been at the center of everything we do, right from the beginning.
Cardiaccs Monitoring System
The CardiaSense CS1 lead has an embedded accelerometer and can be placed epicardially using two electrode anchors. A straight atraumatic thorax needle is used to penetrate the chest, and the needle is unscrewed to allow connection to the accessory CB1 and a standard external pacemaker.
The CB1 connects to the patient monitor using USB. The monitor runs our proprietary CM Software for continuous monitoring of myocardial velocity.
Follow our clinical trial program at www.sambafun.eu
Intended Use
The CardiaSense CS1 is intended for continuous cardiac function monitoring and temporary left ventricular pacing and sensing in patients undergoing open heart surgery. CS1 can be used on all patients in need of myocardial function monitoring and temporary ventricular pacing. CS1 can be used during and after cardiac surgery, in the operating room, intensive care unit or the general ward, for up to 7 days.
TM
TM
Research
The datasheet of the CS1 research device can be downloaded here and is now available for order
Contact us for more info on the research device
The CS1 research product is suitable for animal trials and is NOT FOR HUMAN USE
The CS1 research device can be used for measuring acceleration in 3-axis and can be placed epicardially on the left or right ventricle. Some example applications are outlined in the previous research performed on 3-axis accelerometers for heart function assessment.
Detection of myocardial ischaemia by epicardial accelerometers in the pig
2008
British Journal of Anaesthesia,
Oxford Journals
Halvorsen et al
Halvorsen et al
Feasibility of a three-axis epicardial accelerometer in detecting myocardial ischemia in cardiac surgical patients
2008
Left ventricular function can be continuously monitored with an epicardially attached accelerometer sensor
2014
Hyler et al
Grymyr et al
Assessment of 3D motion increases the applicability of accelerometers for monitoring left ventricular function
2014
Continuous monitoring of cardiac function by 3-dimensional accelerometers in a closed-chest pig model
2015
Grymyr et al
Grymyr et al
Detection of intraoperative myocardial dysfunction by accelerometer during aortic valve replacment
2016
Krogh et al
Continuous estimation of acute changes in preload using epicardially attached accelerometers
2020
Team
Lucile holds a masters degree in
mechanical engineering and has several years of experience from medical device design, quality and regulatory compliance.
Jonas holds a masters degree in engineering cybernetics from NTNU and has several years of engineering and R&D experience, both within tech startup and multinational IT. Jonas is heading the CardiaSense project.
Knut Halvor holds a masters degree in computer science from NTNU and has more than 10 years of SW development experience. Knut Halvor is developing the CM Software for CardiaSense
Mattis holds a masters degree in electrical engineering from NTNU and has over 4 years of experience in medical device development where he has played a key role in the design phases, risk management and 60601-1
Paul Gordon
Clinical Affairs Manager
Paul holds an MSc in pharmacy and a PhD degree in cancer cell biology. He has more than 25 years of experience in clinical trial design, management, and execution with world leading companies.
Dorian holds an Masters degree in quality assurance, validation methods and quality control. He has several years of experience from medical device manufacturing and process validation for ISO 13485 and FDA 21 part 11 compliance.
CEO, Founder and Chairman
Erik has a lifelong experience as a cardiothoracic surgeon and is head of department at the Intervention Centre at Oslo University Hospital. He has 10 patent applications and has participated in establishing multiple medical companies.
Member of the Board
Ulf is an accountant and has 20 years of experience as economical advisor and business developer. He is CEO/CFO of 5 companies and owner of Finanstorget AS, an authorized accounting company.
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