Corporate | 8 August 2012 10:11

Geratherm Medical AG: The international medical journal ‘Stroke’ published convincing results of a clinical trial conducted at the University Hospital Heidelberg, Germany

Geratherm Medical AG / Key word(s): Study

08.08.2012 / 10:11

Clinical Trial Substantiates Superiority of SRAclinic in the Detection of Atrial fibrillation

The international medical journal ‘Stroke’ published convincing results of a clinical trial conducted at the University Hospital Heidelberg, Germany

SRAclinic shows significant superiority over standard procedures – 40 percent more patients with paroxysmal atrial fibrillation identified

Geratherm/apoplex, Pirmasens, 08. August 2012. Throughout Germany, in France and Austria, more than 30 hospitals (stroke units) already use successfully the fully automated ECG analysis for the detection of atrial fibrillation SRAclinic (SRA = Stroke Risk Analysis), developed by the apoplex medical technologies GmbH, Pirmasens (Germany). The medical journal ‘Stroke’, an official journal of the American Heart Association, just published the results of a clinical trial, which proves a clear superiority of SRAclinic* to the current standard procedures for the detection of paroxysmal atrial fibrillation. This is of great importance especially for those patients with strokes of unknown origin. Only the detection of atrial fibrillation makes an adequate therapy with anticoagulating drugs possible to reduce the risk for further strokes.

The publication in ‘Stroke’ is based on a prospective study conducted by the principal investigator Prof. Dr. med. Roland Veltkamp, between March 2010 and January 2011 on approximately 500 patients at the stroke unit of the University Hospital Heidelberg. The study compared the detection rate of paroxysmal atrial fibrillation of SRAclinic with the current standard procedure. The investigators succeeded in proofing superiority of SRAclinic over the 24 hour long term ECG and the ECG monitoring without the automated detection software in the identification of patients with paroxysmal atrial fibrillation.

‘SRAclinic has clearly proven it’s superiority over the elaborate methods used in our stroke unit to detect atrial fibrillation’, states Prof. Dr. med. Roland Veltkamp. ‘After the analysis of the study results we changed the routine diagnostic for the detection of paroxysmal atrial fibrillation at our stroke unit with 20 beds completely to SRAclinic. The anyway recorded ECG signals from the monitoring system at the stroke unit are analysed by SRAclinic. 24 hour long term ECGs are only recorded in exceptional cases which means a considerable relieve for our colleagues from cardiology.’

This is the link to the online published abstract in ‘stroke’.

http://stroke.ahajournals.org/content/early/2012/08/07/STROKEAHA.112.654954.abstract?sid=53a0663e-7a28-4fb7-b841-cb9dab80d5e0

The full paper can be accessed online on the internet page of ‘stroke’ after registration.

‘SRAclinic is well on the way to become the standard procedure for the detection of paroxysmal atrial fibrillation in stroke units. In about 25 percent of all strokes in Germany the origin of the stroke cannot be identified. A substantial part of these is assumed to be caused by undetected paroxysmal atrial fibrillation, which increases the risk for secondary strokes with worse consequences for the patients’ states Albert Hirtz, Managing Director of apoplex medical technologies GmbH. ‘New methods do not necessarily induce higher costs but can often reduce the current costs – with benefits for the patients and the insurance companies. SRAclinic is safe, reliable and a resource-efficient solution, as it uses data from the monitoring system for the analysis’ emphasizes Albert Hirtz the economical advantages of SRAclinic.

Convincing Study Results
The objective of the study was a comparison of the two presently applied standard procedures in stroke units, which are 24 hour long term ECG and patient monitoring, with SRAclinic in relation to an identification of patients with previously unknown paroxysmal atrial fibrillation. Patients with ischemic stroke or TIA (transitional ischemic attack) were included in the study. During their stay at the stroke unit, in 41 from 496 patients paroxysmal atrial fibrillation was detected for the first time. 14 (34.1%) patients were found with 24 ECG recordings, 27 (65.9%) with the continuous bed side electrographic monitoring and 38 (92.7%) have been identified with SRAclinic. That means, SRAclinic is able to increase the detection rate for paroxysmal atrial fibrillation more than twofold compared to the widely used 24 hour long term ECG recording.

Background information to SRAclinic
The fully automated S troke R isk A nalysis SRAclinic , developed by the apoplex medical technologies GmbH, Pirmasens, for the detection of atrial fibrillation is already used in the stroke units of more than 30 hospitals in Germany, France and Austria.
SRAclinic is analysing the ECG data from the mandatory patient monitoring or from long term ECG recordings. The analysis is based on a mathematical algorithm which interprets deviations from the heart rate dynamics which come along with atrial fibrillation. There is also a version for primary prevention (SRAdoc und SRA24), which is offered to General practitioners.

Supplementary information about apoplex medical technologies
apoplex medical technologies GmbH was founded in 2004 in Pirmasens, in the west of the Rhineland-Palatinate, and, within the field of medical technology, specializes in new and innovative technological products for the prevention of strokes throughout the world. The subsidiary of Geratherm Medical AG focuses on easily applicable and efficient methods of patient screening using medical-technical applications to prevent strokes and vascular dementia. The SRA (Stroke Risk Analysis) procedure is the first practicable screening method for paroxysmal atrial fibrillation. It is available in versions for use in medical practices and stroke units. apoplex medical technologies is supported by an extensive academic and clinical network, which professionally supplements its own core competences in the fields of mathematics, physics and medicine. Further information is available at www.apoplexmedical.com .

Additional information
apoplex medical technologies GmbH
Albert Hirtz
Delaware Avenue 1 – 3
D-66953 Pirmasens
fon: +49/(0)6331/698998-0
fax: +49/(0)6331/698998-19
http://www.apoplexmedical.com
a.hirtz@apoplexmedical.com

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Language:	English
Company:	Geratherm Medical AG
	Fahrenheitstraße 1
	98716 Geschwenda
	Germany
Phone:	+49 (0)36205 98-0
Fax:	+49 (0)36205 98-1 15
E-mail:	info@geratherm.com
Internet:	www.geratherm.com
ISIN:	DE0005495626
WKN:	549562
Listed:	Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, München, Stuttgart

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