News

Professor Stephan Haulon as Medyria Clinical Study Report Independent Reviewer

February 26, 2019

Prof. Stefan Haulon from Marie Lannelongue Hospital in Le Plessis Robinson, France, accepted to serve as independent Medyria clinical study report reviewer. Medyria expect to submit to NSAI in April 2019  

Dr. med. Jörg Teßarek as Independent CRF reviewer of Medyria First in Human Clinical Trial

February 17, 2019

Adjudication of clinical study CRF's is progressing well. Dr. Tessarek from Bonifatius,  Lingen, Germany, accepted to be the independent reviewer of our CRF's 

Medyria finalized the 40 patient enrollment in First in Human Germany based Clinical trial

February 14, 2019

40 EVAR patients were enrolled and treated safely using TrackCath Technology. 

Medyria First in Man Clinical Trial enrolled 25 patients successfully

The Germany based 32 patients multi center clinical trial held in UKD, Dusseldorf (Principal Investigator and study coordinator , Prof, Hubert Schelzig), UniKlinik Aachen (Dr. J. Kalder), UnliKlinik Leipzig (Dr. A. Schmidt)  and UKE Hamburg (Prof. T.Koelbel), has enrolled and treated 27 EVAR patients so far. 

"I believe that this product can reduce the use of contrast dye and reduce the radiation to patient and to the surgeons. The trackCath system appears to be of great help for the cannulation of visceral arteries in complex cases. I am looking forward to see the outcomes of the multi-center first in man ACCESS study." said Dr. Andrej Schmidt, principal investigator from Leipzig

October 07, 2018

Medyria received EN ISO 13485:2016 certification from NSAI.

Medyria has achieved the highest quality standards in Europe for the design, manufacture and distribution of intravascular flow sensing catheters and associated monitoring systems. 

Medyria AG to present TrackCath®, Blood Flow Velocity Measuring System for safer EVAR procedures at Charing Cross 2018.

April 23, 2018

Source: Medyria AG

 

LONDON and Winterthur - April 24, 2017 - Medyria AG today announced that it will be presenting TrackCath®, Blood Flow Velocity Measuring System at Charing Cross Symposium (CX), one of the world's largest educational meetings specializing in vascular and endovascular disease management, in London from April 24-26, 2018

 

An abstract on ‘TrackCath system; new approach to cannulation(s)’ will be presented by Dr. Zoran Rancic, MD, PhD Clinic For Cardiovascular Surgery, University Hospital of Zurich, Switzerland.

 

The TrackCath Catheter Positioning System consists of a catheter, flow measurement unit and a monitor. A patented sensing technology measures the blood’s velocity and identifies for the accurate positioning and cannulation in the aorta for significantly reducing the use of X-ray and contrast dye during the Endovascular Aneurysm Repair (EVAR) procedures.

 

Reducing the amount of contrast dye injected in chronic kidney disease (CKD) patients is aligned with cardiology and radiology society guidelines that urge physicians to use dye sparing approaches in patients at risk of Contrast-induced acute kidney injury (CI-AKI). Prevention of CI-AKI may lead to shorter hospital stays, improved patient outcomes, and may ultimately save patients’ lives.

 

According to several studies conducted by Dr. Athanasios Saratzis MBBS FHEA PhD FRCS at NIHR Leicester Biomedical Research Centre UK, pre-existing chronic kidney disease is prevalent in 40% of EVAR patients (Saratzis et al. Ann Vasc Surg. 2016; 31) and the CI-AKI related short and long term mortality rates post procedure are at 4.8% and 2.4% respectively (Saratzis et al. EJVES 2015; 49). In the UK alone, this represents and additional £12.2 million in extra treatment costs and >5,100 extra bed days annually (Saratzis et al. Kidney International 2017)

 

About Medyria

Medyria AG is a Switzerland based company that has successfully developed an innovative and proprietary sensorized catheter, the TrackCath System designed to protect kidneys from the harmful effects of X-ray and contrast dye in Endovascular Aneurysm Repair procedures (EVAR).

 

Medyria's mission is to make TrackCath® a standard of care for patients suffering from Chronic Kidney Disease during EVAR procedures.

Medyria announces the successful First in Human trial of its novel TrackCath System™

March 19, 2018

TrackCath System™, the novel Medyria Blood Flow Velocity Sensor equipped catheter was carried out safely and exhibited the intended benefits during a First in Human EVAR procedure performed on 20 March 2018 in UniKlinik RWTH, Aachen by PD. Dr. Johannes Kalder, Vascular Surgeon and Deputy Chief of the Department of Vascular Surgery, University Hospital; RWTH Aachen, Germany

PD. Dr. Johannes Kalder said “TrackCath System™ was used for the identification of coeliac trunk, superior mesenteric artery and right renal artery. The TrackCath System™ Blood Flow Velocity Measurement worked smoothly and allowed quick and easy identification of the three vessels. Cannulation was performed in the superior mesenteric artery using the TrackCath System™ catheter.  

TrackCath System™ provides exceptional support during wire exchange. I have been involved in the early stage development and animal studies of TrackCath System™ with Dr. Mauro Sette, founder and Chief Technology Officer of Medyria. I always believed in the TrackCath System technology, as it is designed to answer a clear unmet need.  I am now very pleased to be associated with the clinical development of TrackCath System™

Gilles Lachkar, CEO of Medyria, said “This is a major milestone for both Medyria and for the advancement of effective identification and cannulation of side branches during EVAR procedures. Medyria is developing the TrackCath System™ to bring accuracy and speed during the cannulation phase of complex EVAR procedures. This successful first clinical result confirms the promise of the TrackCath System™ in improving the management of complex EVAR and reducing utilisation of X-rays and Contrast dye during the procedure”

Medyria First in Human trial (Access Trial) is a prospective, single-arm, multicentre clinical trial performed on 32 patients treated with standard or complex EVAR procedures.

Access trial is a necessary step towards CE-Mark and is geared to be completed by summer 2018 according to initial plan.

The objective of the study is to assess the safety and performance of the TrackCath System™ to establish clinical evidence. Secondary objectives encompass additional scientific data such as procedure duration, C-dye consumption and X-ray exposure.

Investigational sites are:

Universitätsklinikum Düsseldorf  - Klinik für Gefäß- und Endovaskularchirurgie:

Prof. Dr. med. Hubert Schelzig (Country Coordinator)

 

Universitätsklinikum Aachen – Klinik für Gefäßchirugie:

Priv.-Doz. Dr. med. Johannes Kalder

 

Universitätsklinikum Hamburg – Universitäres Herzzentrum Hamburg GmbH (UHZ) – Klinik und Poliklinik für Gefäßmedizin:

Prof. Dr. med. Tilo Kölbel

 

Universitätsklinikum Leipzig – Klinik und Poliklinik für Angiologie:

Priv.-Doz. Dr. med. Andrej Schmidt 

Medyria closes series B round and receives approval for first-in-man clinical trial

December 28, 2017

Medtech startup Medyria specialising in cardiovascular catheter navigation and sensing has successfully closed its series B round at CHF 3.7 Million with a contribution of CHF 1.28 from investiere.ch.

With the funds from the B round closing, Medyria is now set for their first-in-man clinical trials for its catheter positioning system, thanks to the green-light from the German Federal Institute for Drugs and Medical Devices (BfArM).

“We always believed in Medyria’s highly relevant technology in the fast-growing market of endovascular surgery and recognized its potential already in 2014 when we conducted a first investment round and added it to our portfolio”, says Michael Blank, Investment Manager at investiere.ch. “We are very happy and proud that we could enable our investors to participate in two financing rounds before the first human trials and we look forward to continue supporting Medyria along its journey.”

Medyria has developed a catheter positioning system with the potential to significantly reduce the use of x-ray and contrast dye. Today, such interventions are visualized using x-ray and contrast-dye, both of which can lead to severe health complications. In fact, 41% of patients are at risk of developing kidney damage or allergic reactions to the dye. Medyria’s technology significantly reduces patient risks and cuts costs by shortening hospital stays and eliminating toxic contrast dye complications. Numerous project milestones have already been reached, including successful animal trials as well as product verification and validation. Medyria will begin the human trials in the coming weeks.

BfArM Approval

December 28, 2017

BfArM, the competent federal higher authority in Germany, approved Medyria Access First in Man clinical trial today. 

This is a major milestone for Medyria 

Access trial will be conducted in trial patients in order to assess the safety and the performance of TrackCath System, Medyria's innovative sensorized catheter, in EVAR patients.

Medyria welcomes a new CEO

July 31, 2017

Medyria names Gilles Lachkar, a seasoned bio-pharma and med-tech industry executive, as CEO

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CAUTION - Investigational device. Limited by law to investigational use.