90 days preclinical study ended on Sept. 8, detailed examinations in process, these picture upfront.
Cor/log Probe 1P has been successfully used in ten patients in three different hospitals across Germany. Hemodynamic state changes of different surgical and transcatheter based procedures were recorded.
Compare waveforms before and after interventions at different points of time up to 30 days in total:
See the exact moment of intervention and the hemodynamical state change that follows:
First in world mobile, wireless measurement of right atrial pressures during activity of patient:
emka MEDICAL started a structured preclinical experiment in a validated preclinical lab with referenced measurements (two probes per insertion site, used as implants, altogether 36 probes) for several periods of indwelling times, time lines much above 30 days, and these picture show performances within first days.
Further patient applications with tricuspid interventions got executed in Hamburg also in May, 2020, results to be reserved for planned publications of the cardiologists in charge.
Cor/log Probe 1P for assist pressure monitoring (at axial heart pump hear assist) got CE marked March 19, as medical device of class IIa, for right atrium pressure monitoring (then class III) emka MEDICAL has started application for a clinical trial along ISO 14155 at BfArM. Still clinical data will be collected through pathway EU-MDR-Annex XIII, custom-made devices, to evaluate CE conformity for the jugular venous pressure sensing application, in such case Cor/log Probe 1P will be medical device of class IIb.
The DGK congress April 15-18 got cancelled, we will not exhibit, but we got an advertorial about Cor/log Probe 1P in “Spitzenforschung Herz-Kreislauf-Medizin 2020” related to DGK, will be visible on our NEWS soon.
We will exhibit on the DKG congress 2020 in Mannheim from April 15 to April 18, congress subject “the multimorbid heart patient” fits to our mobile monitoring capabilities of Cor/log Probe 1P.
Prof. Schofer, Hamburg, has submitted a lecture about „First wireless right atrial pressure measurement in patients with severe tricuspid regurgitation before and after percutaneous or surgical treatment“, Abstract will be available after acceptance by DGK here on the NEWS as link. That relates to the October 2019 NEWS with picture of a used Cor/log Probe 1P.
Our DGK booth number will be: 026, Level -1.
Cor/log Probe 1P got successfully used in human applications in two different clinical sites in September and October. Both clinical partners are preparing publications so emka MEDICAL is waiting with further presentations until publication.
For now we can present you a photo of one used Cor/log Probe 1P after an indwelling time of one week.
Successful in-vivo experiment in May 2019. Two Cor/log Probe 1P were implanted into a freely moving pig. Zero drift of the pressure baseline over 29 days. Measurement of S1 and S2 heart sounds due to high frequency resolution of the probe. This can be used to identify the a- and v-wave of the central venous pressure which can be used to diagnose tricuspid valve regurgitation. Continuous data transfer during this time to Cor/log Connect and Cor/log App.
We will be presenting our Cor/log System at the Hamburg Heart Days 2019 from 17 to 18 May. You can visit us at booth 22 in the tent. We are excited to talk to you about monitoring of structural heart diseases in the right heart.
After much work and effort of our team, we are proud to present the finalized system for Cor/log Probe 1P.
Take a look at our short presentation of the system and its applications. Cor/log Probe 1P will be soon available for the European market.
You can meet us on the Annual Congress of the German Society of Cardiac and Thoracic Surgeons midst of February 2019 in Wiesbaden.