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Cardiaccs

Solution Provider

Cardiaccs AS

Contact person

Jonas Tyssø

Regulatory Status

ISO 13485 & pending regulatory approval

CHALLENGE AND SOLUTION

Current Situation
Today, 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. Surgeons have access to different ways of monitoring the function of the heart after surgery, however these tend to be either inaccurate, episodic or involve a high risk to the patient.

Customer Challenge
Surgeons and cardiologists want to be able to monitor the function of the heart more accurately and continuously without introducing additional risk to the patient or significantly altering the surgical and monitoring process. More timely and accurate monitoring and diagnosis of cardiac complications post surgery will reduce cost for healthcare systems and improve patient outcomes.

Our Solution
Cardiaccs has developed a unique and innovative method for cardiac monitoring that leverages technology that surgeons have been using for more than 30 years. Our solution provides highly accurate and continuous data on the function of the heart without changing the surgeon’s behavior. The high precision real-time data allows for improved patient recovery and early detection of cardiac dysfunction.

TECHNOLOGY DESCRIBED

CardiSense CS1® Lead
CardiSense is a combined motion sensor and temporary pacemaker lead that is placed on the heart surface up to 7 days after open cardiac surgery.
The sensor monitors the heart function with high accuracy in real time. The lead is placed and removed through the same procedure as normal pacemaker leads, so surgeons require no training to start using this device.
This sensing approach is patented and owned exclusively by Cardiaccs.

Accessories and Software
The sensor connects to external equipment by means of proprietary connections and accessories.
Cardiaccs’ monitor with proprietary software displays the heart function continuously, allowing early detection of complications and cardiac dysfunction such as bleeding and myocardial ischaemia
Click here for a 3D animation showing placement and connection to monitoring equipment and standard external pacemakers.

About Cardiaccs
Cardiaccs is a Norwegian ISO 13485 certified medical device manufacturer. The technology is pending regulatory approval. Multi-centre clinical trials for CEmarking under MDR is planned end of 2020