First HCTronic Heater-Cooler System installed at the Erasmus MC Medical Center in Rotterdam

04-16-2022

During recent months, our first HCTronic Heater-Cooler System installed at the Erasmus MC Medical Center in Rotterdam has been utilized during a wide variety of cardiac procedures ranging from straight forward normothermic CABG surgery to complex aortic surgery procedures requiring deep cooling. We are glad to announce that based on their early experience, we have received approval to start converting all Operating Rooms to our new system, which obviously is a great milestone!

 

We have been using the Limited Market Release to obtain feedback on our product and validate our processes. This information will be very valuable while we are moving towards a broader market introduction.

 

Please feel free to reach out to us if you have any questions or follow us on Linkedin if you want to be kept up-to-date: HCTronic Heater Cooler B.V.

 

The HCTronic Heater-Cooler System concerns a new generation HCU for use during cardiac procedures in conjunction with a Heart-Lung Machine (HLM). Our system uses proprietary heat pump technology (patent pending) to control the temperature without the need for buffer tanks and has a fully automated cleaning cycle to avoid manual chemical cleaning like conventional systems currently on the market.

Certification

Medical Device Regulation (EU) 2017/745 certified.

The HCS-1 device is a class IIb medical device in accordance with Regulation (EU) 2017/745.
Approved for clinical use in the European Union.