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About Us
At Berlin Heart we do everything we can to provide people with heart failure with the best possible care. The aim of our work is to ensure that these patients live well despite their illness.
Berlin Heart GmbH develops, produces and markets innovative systems for mechanical circulatory support. With our products EXCOR® Adult and EXCOR® Pediatric, we cover the entire scope of medical indications. We are the only company in the world offering systems that can support patients of every age and size, from newborns all the way to adults.
Our systems are used for left, right* or biventricular (bilateral) circulatory support: EXCOR®, Berlin Heart’s paracorporeal VAD, is virtually unrivaled in the domain of biventricular circulatory support.
With our world-renowned products, we are one of the industry's market leaders. We aspire to develop pioneering solutions with the highest precision and reliability. Our developments are always geared toward the needs of our customers and the requirements of the market – and will continue to do so in the future.
(*EXCOR® Adult and EXCOR® as RVAD are not FDA approved.)
At Berlin Heart we do everything we can to provide people with heart failure with the best possible care. The aim of our work is to ensure that these patients live well despite their illness. These are our guiding principles:
We support our users during the entire VAD therapy: from patient selection and preparation to implantation and postoperative care. Therefore, we provide a top level 24/7 medical and technical support.
Berlin Heart products and services stand for high quality “Made in Germany”. We produce our blood pumps, cannulae and driving units at our headquarters in Berlin-Lankwitz. Regular audits and certification processes prove the quality of our products.
We invest about half of our turnover in research and development projects. Using state-of-the-art technologies and professional expertise, we are constantly working to develop new products as well as develop existing products further. In research groups, we discuss with clinicians how the VAD therapy can be improved.
With our products we support newborns and children, for whom no approved long-term support exists otherwise. Our sense of responsibility towards patients with heart disease is also reflected in our commitment. For example, we support the McDonald's Kinderhilfe and are committed to an open discussion on organ donation.
CE-Approval of the EXCOR® Venous Cannula
The EXCOR® Venous Cannula enables a standardized implantation of the EXCOR® VAD to support the sub-pulmonary circulation of patients with venous connection abnormalities (e.g. Fontan circulation). Patients with failing Fontan circulation thus receive a new chance for a donor heart.
CE-Approval of the EXCOR® Graft Cannula
The new EXCOR® Graft Cannula is designed to offer the surgeon more options for cannulation during the implantation of the EXCOR® system.
Berlin Heart is one of the first companies worldwide whose quality management system was successfully audited according to the new MDR.
The new mobile driving unit EXCOR® Active receives CE marking.
![[Translate to Englisch:] EXCOR<sup>®</sup> Active](https://www.berlinheart.de/fileadmin/_processed_/2/3/csm_EXCOR_Active_frontal_6cfd2ea649.png "[Translate to Englisch:] EXCOR<sup>®</sup> Active")
EXCOR® Pediatric receives full pre-market approval (PMA) in the US market.
Pre-market approval is received for EXCOR® in South Korea.
Pre-market approval is received for EXCOR® Pediatric in Japan.
The EXCOR® blood pump with bileaflet valve receives CE approval.
The EXCOR® Pediatric 15 ml blood pump receives CE approval.
Longest support period of 2.5 years with EXCOR® Pediatric in a small child.
The FDA Humanitarian Device Exemption (HDE) is received for the EXCOR® Pediatric system in the US market.
The 500th patient receives the implantable INCOR® ventricular assist device at the German Heart Center.
The daughter of the US football star Charles Tillman is supported with EXCOR® Pediatric until her heart transplantation – the case attracts great media interest.
Berlin Heart receives the Investigational Device Exemption (IDE) approval (USA) for EXCOR® Pediatric, beginning of a prospective multi-center study.
Acquisition of Berlin Heart by a private investor and change of the company’s legal status to GmbH.
Foundation of the US subsidiary Berlin Heart Inc.
The story of EXCOR® Pediatric patient Miles Coulson appears on the front page of The New York Times and marks the beginning of a massive increase in demand in the USA and around the world.
After successful completion of the multi-center study, INCOR® receives CE approval.
INCOR® is used for the first time in a clinical trial. The heart of the then 42-year-old patient recovers so well that the system is explanted after just six months.
Foundation of Berlin Heart AG through a merger with the predecessor company, Mediport Kardiotechnik GmbH.
The mobile driving system Excor mobile receives CE approval.
Development work begins on INCOR®.
Fehling Medical AG acquires the EXCOR® VAD system.
Foundation as Mediport Kardiotechnik GmbH by the German Heart Center Berlin and private investors, CE approval of the EXCOR® stationary driving unit Ikus.
1st EXCOR® Pediatric implantation in the USA.
1st pediatric EXCOR® Implantation at the German Heart Institute in Berlin, Germany am Deutschen Herzzentrum in Berlin.
1st EXCOR® LVAD implantation at the German Heart Insitute in Berlin by Prof. Dr. Hetzer.
Sven-René Friedel
General Manager
Departments: Finance & Administration, Research & Development, Regulatory Affairs & Quality Management
Mr. Friedel studied economics in Fulda and Berlin with a focus on Accounting & Controlling and Innovation Management. He has known the development of the Berlin Heart since its very beginnings. Initially Mr. Friedel was responsible for various international VC financing activities as Head of Finance. In 2006 he commandeered the sale of Berlin Heart to its current owner. Following the establishment of the subsidiary Berlin Heart Inc. in the USA in 2008, he took over the management of ECP Entwicklungsgesellschaft mbH in addition to the commercial management at Berlin Heart. ECP pursued the development of a highly innovative percutaneous assist system for cardiology applications. In 2014 Mr. Friedel realized their successful sale together with a wide-ranging IP portfolio to Abiomed Inc.
Since October 2014 together with Dr. Ares K. Menon he manages the business of Berlin Heart.
Dr. med Ares K. Menon
General Manager
Departments: Field Operations (Sales & Clinical Affairs), Clinical Science, Marketing & Business Development, Production
Dr. Menon was trained as a specialist in cardiac surgery at the University Hospitals in Düsseldorf and Tübingen. He then worked as a senior physician first at the University Hospital Giessen and later at the University Hospital of the RWTH Aachen in cardiac, pediatric cardiac and vascular surgery. In addition to the entire spectrum of cardiovascular surgery, his operative focus was on off-pump bypass and aortic surgery and cardiac transplantation. In Aachen he set up and managed the Department of Cardiac Support Systems. He has extensive and long-standing experience in the implantation of short and long-term VAD systems as well as in the follow-up care of VAD patients.
After joining Berlin Heart in 2013 as Division Head for Clinical Issues and Direct Sales in Germany, Dr. Menon was responsible for Global Sales from mid-2013 and served as Medical Director. He has been Managing Director since October 2014 together with Mr. Sven-René Friedel.
In order to stay true to our values at Berlin Heart, we act according to the following principles:
In April 2015, users of the Berlin Heart system EXCOR® Pediatric founded the European EXCOR® Pediatric Investigator Group (short EEPIG). The group now consists of more than 50 VAD experts from 15 countries. The aim of the research group is to discuss and improve various aspects of pediatric VAD therapy. The biannual EEPIG meetings also provide a platform for the initiation of multicenter studies. A working group formed by the EEPIG deals, for example, with the topic of anticoagulation. A corresponding study, the Thromboembolic RIsk Study (TRIS), is currently in preparation.
Representatives of various European VAD clinics form the biventricular heart failure research group. At regular meetings, members evaluate approaches for optimal treatment of patients with biventricular heart failure. Within the research group, the prospective study "Successful support of biventricular heart failure patients by new EXCOR® Adult pumps with bileaflet valves" by Schmack et al. emerged.
Berlin Heart GmbH is part of the joint project "AMVAD": Additive Manufacturing for Cardiac Assist Devices, funded by Investitionsbank Berlin.
The project aims to develop a process that enables the use of additive manufacturing (AF) for the production of high risk medical devices (MP). This is to be developed and demonstrated using the example of a cannula with patient-specific geometry. In addition, the design and documentation of the development process is to be realized in order to enable a later, possible approval for individual medical devices.
The entire process chain will be investigated, starting with medical imaging and processing, through computer-aided product design, to product manufacture using AF, including process validation and proof of the safety and performance of the individually manufactured product. In this context, additive manufacturing technologies open up possibilities for patient-specific care for previously unprovided patient groups, while at the same time ensuring a high level of safety through a complete approval process.
For medium-sized medical technology companies, such a process means that even products with smaller quantities become economically feasible and can thus be realized. This is essential, especially for medical technology products in the field of pediatric applications, in order to be able to develop and offer therapy options. For small innovative companies, especially start-ups and small medium-sized enterprises, the time-to-market should also be significantly reduced.
The project is a joint project with the Gesellschaft zur Förderung angewandter Informatik e.V. (Society for the Advancement of Applied Computer Science, registered non-profit association, GFaI), the Institute of Computer Science, Humboldt University of Berlin (HU), the Zentrum zur Förderung eingebetteter Systeme e.V. (Center for the Advancement of Embedded Systems, ZeSys) and the Department 5.4, Biomaterials, Multimaterial Manufacturing Processes, Bundesanstalt für Materialforschung und -prüfung (Federal Ministry for Economic Affairs and Climate Action, BAM).
The project is co-financed by the European Regional Development Fund (ERDF).
With its houses, the foundation offers families of seriously ill children a home near the clinic where the young patients are being treated. As we know how important family closeness is, especially for young patients, we support the foundation and in particular the Ronald McDonald House in Berlin-Wedding. As an annual Christmas donation Berlin Heart assumes the sponsorship for an apartment and therefore its maintenance costs. In addition, our employees get involved in a very personal way: amongst others with renovation campaigns, cooking evenings for the residents of the house or through specially arranged bake sales.
![[Translate to Englisch:] Organspende](https://www.berlinheart.de/fileadmin/user_upload/Berlin_Heart/Bilder/30_Uber_uns/organspende.jpg "[Translate to Englisch:] Organspende")
Organ donation: While the number of patients on the waiting lists is steadily increasing, the number of available organs has been declining for years. At Berlin Heart we know what the often long wait for a donor heart means for the patients. This is why we want to draw attention to this problem all the more. Within and outside of our company, Berlin Heart is therefore committed to an open and conscious debate on the issue of organ donation.
![[Translate to Englisch:] Labdoo](https://www.berlinheart.de/fileadmin/user_upload/Berlin_Heart/Bilder/30_Uber_uns/Labdoo_Sambia.jpg "[Translate to Englisch:] Labdoo")
Labdoo: This charitable aid project gives children and young people access to IT and education. Berlin Heart supports Labdoo by donating PCs and laptops. The equipment benefits young people in schools, orphanages, child, youth and refugee projects in 107 countries worldwide. The hardware and Labdoo-added software allow pupils and refugees to take full advantage of the digital opportunities.