April 2021

CorLog App achieved CE as a class IIa software as medical device.

CorLog App receives, stores and displays blood pressure profiles wirelessly sent from CorLog Probe 1P. One key function of CorLog App is the compare mode which allows users to display two blood pressure profiles. This enables the user to differentiate between hemodynamic states of the patient.

Right atrial pressure before and after tricuspid valve repair
Right ventricular pressure of COVID-19 patient at the beginning and at the end of therapy

March 2021

A paper gets prepared for publication to demonstrate clinical value of CorLog Probe 1P, title, authors:

Continuous long term wireless measurement of right ventricular and pulmonary arterial pressure in patients with severe COVID-19 pneumonia using a newly developed right ventricular pressure transducer, by Gärtner M+, Glocker R++, Glocker F++, Hopf HB+
+ Dept. of Anesthesia, perioperative medicine and interdisciplinary intensive care medicine, ECLS-ECMO center Langen, Asklepios Klinik Langen, Roentgenstrasse 20, 63225 Langen
++ emka MEDICAL GmbH, 63739 Aschaffenburg, Germany

“Since 2020 newly developed ultrathin catheter tip transducer for long term application have been used, introduced percutaneously via the internal jugular or subclavian vein into the right ventricle for wireless continuous measurements of right ventricular pressures and the estimated diastolic (ePAD) und mean (mPAP) pulmonary artery pressure in patients with severe ARDS caused by COVID-19 pneumonia who all were invasively or noninvasively mechanically ventilated. Preliminary results will be presented”

That means in more than 30 patients in run times up to 30 days four pressures are lined up in historical evolution and there is correlation (significance proven) between cardiac pressure control and survival.

January 2021

180 days preclinical study ended on Jan. 21, detailed examinations in process. Picture of catheters right after opening ventricle below.

Picture 1: Catheters after opening ventricle

More in short time.

November 2020

CorLog Probe 1P in times of COVID-19

emka MEDICAL GmbH has developed an innovative technology for measuring invasive pressures. The focus is on measuring blood pressures. The main goal of using this technology is to monitor and adapt therapy for general heart failure. On the way there, emka MEDICAL is also exploring other applications such as structural heart diseases (tricuspid valve insufficiency), cardiac support systems and pulmonary arterial hypertension (PAH). The development goes from short-term applications of up to 30 days to long-term applications in which CorLog is implanted.

In the future, CorLog Probe 1P could also play a role in the fight against COVID-19. COVID-19 often increases the flow resistance of the lungs and thus the pressure (pulmonary artery pressure), see figure 1. According to guidelines for pulmonary arterial hypertension (PAH), this should be examined with a right heart catheterization. This complex procedure, which is also stressful for the heart valves, only provides one-time information. Using CorLog Probe 1P not only saves you this procedure, you also get continuous and mobile pressure values of up to 30 days. These pressures can then be used to adjust pharmaceutical therapy to bring PAH under control.

Figure 1: COVID-19 effects that can lead to pulmonary hypertension and right heart failure [1].

Pulmonary hypertension [1] can also damage the right ventricle [3] [4] and cause right heart failure [1] [2]. Both pulmonary hypertension and changes in the right ventricle can be measured using CorLog [5], see also figure 2.

Figure 2: Right ventricular pressure (black) and part of the curve that is common with pulmonary artery pressure (red). Localization of the area with the help of the first time derivative of the pressure.

In contrast to other solutions, patients can be mobilized with CorLog. This can be used to carry out stress tests which can be monitored wirelessly with CorLog.

The use of CorLog for severe courses of COVID-19 with pulmonary hypertension is currently being investigated by intensive care physicians. Publications are planned.

Quotes:

[1] Park JF, Banerjee S, Umar S. In the eye of the storm: the right ventricle in COVID-19. Pulm Circ. 2020;10(3):2045894020936660. Published 2020 Jul 2. doi:10.1177/2045894020936660

[2] Argulian E, Sud K, Vogel B, et al. Right Ventricular Dilation in Hospitalized Patients with COVID-19 Infection [published online ahead of print, 2020 May 15]. JACC Cardiovasc Imaging. 2020;10.1016/j.jcmg.2020.05.010. doi:10.1016/j.jcmg.2020.05.010

[3] Basso C, Leone O, Rizzo S, et al. Pathological features of COVID-19-associated myocardial injury: a multicentre cardiovascular pathology study. Eur Heart J. 2020;41(39):3827-3835. doi:10.1093/eurheartj/ehaa664

[4] Li Y, Li H, Zhu S, et al. Prognostic Value of Right Ventricular Longitudinal Strain in Patients With COVID-19 [published online ahead of print, 2020 Apr 28].JACC Cardiovasc Imaging. 2020;S1936-878X(20)30342-9. doi:10.1016/j.jcmg.2020.04.014

[5] Karamanoglu M, Bennett T, Ståhlberg M, et al. Estimation of cardiac output in patients with congestive heart failure by analysis of right ventricular pressure waveforms. Biomed Eng Online. 2011;10:36. Published 2011 May 13. doi:10.1186/1475-925X-10-36

September 2020

90 days preclinical study ended on Sept. 8, detailed examinations in process, these picture upfront.

August 2020

CorLog 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:

May/June 2020

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.

March 2020

CorLog 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 CorLlog 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 CorLog Probe 1P in “Spitzenforschung Herz-Kreislauf-Medizin 2020” related to DGK, will be visible on our NEWS soon.