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.

Profile

Ventricular assist devices for patients worldwide

Berlin Heart GmbH develops, produces and markets innovative systems for mechanical circulatory support. With our products INCOR®, 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. Designed specifically for children, our EXCOR® Pediatric product is the only ventricular assist device approved for pediatric VAD therapy worldwide. We have developed the implantable INCOR® left ventricular assist device for long-term support in adolescents and adults. Our first patient has been reliably supported by the system for more than ten years.

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.

What defines Berlin Heart

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. We follow our principles for this:

Future orientation

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.

Outstanding quality

Berlin Heart products and services stand for high quality “Made in Germany”. We produce our blood pumps, cannulae and drives at our headquarters in Berlin-Lankwitz. Regular audits and certification processes prove the quality of our products.

Responsibility

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 Ronald McDonald's Charity Houses and are committed to an open discussion on organ donation.

Partnership

We support our users during the entire VAD therapy: from patient selection and preparation to implantation and postoperative patient care. If you have any questions, our clinical specialists can be reached around the clock.

History

Milestones in Berlin Heart’s history

FDA grants premarket approval (PMA) for EXCOR® Pediatric in the US

INCOR® patient Wolfgang A. will be supported with the system for more than ten years, setting an INCOR® world record

Market approval of EXCOR® in South Korea

Market approval of EXCOR® Pediatric in Japan

The EXCOR® blood pump with bileaflet valves receives CE approval

The EXCOR® Pediatric 15 ml blood pump receives CE approval

The longest support period with EXCOR® Pediatric in a small child is 2.5 years

FDA grants HDE approval for the EXCOR® Pediatric in the US

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

Full IDE approval (USA) granted for EXCOR® Pediatric, commencement of prospective multicenter study

Acquisition of Berlin Heart by a private investor and change of the company’s legal structure to a limited company ("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 US boom in demand that continues 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 of INCOR® commences

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

Management

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 in the University Hospital Giessen and later at the University Hospital of the RWTH Aachen in cardiac, paediatric cardiac and vascular surgery. In addition to the entire spectrum of cardiovascular surgery, the operative focus was on off-pump bypass and aortic surgery as well as 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 starting his career at 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. Since October 2014 he has served as Managing Director together with Mr. Sven-René Friedel.

How Berlin Heart operates

In order to stay true to our values at Berlin Heart, we act according to the following principles:

  • We orient ourselves to the best and in so doing act as role models an frontrunners in our field
    For this purpose we bring, develop and demand maximum performance. During this process we have integrated all the skills available to our colleagues and employees.
  • We regard the interests of our company as our own
    Everyone acts in a goal-oriented and efficient manner as if the company was their very own.
  • We treat each other honestly, openly and with trust
    We stand by our mistakes, learn from them and accept them also with others.
  • We are an authentic company
    We stick to our promises and deadlines. We make and stand by our decisions, make them transparent, and implement them consistently.
  • Image
    We save lives! We stay true to this very human value and express it outwards.
  • Leadership
    We define clear objectives for ourselves and our staff, and we also implement them responsibly.
  • We achieve optimum quality
    We achieve optimum quality through market-driven, reliable and pragmatic solutions.
  • Market orientation
    We understand and create values that are important for our customers. To achieve this we develop the required competences within a market-oriented business model and in a planned manner.
  • Innovation
    We create the conditions that foster creativity amongst our employees. This has lead to an innovative development of our organization, our value added processes and our product offers.

Clinical research

European EXCOR® Investigator Group

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.

 

Biventricular Heart Failure Research Group

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 bilateral 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.

Research Funding

Together with the Biofluid Mechanics Lab at Charité – Universitätsmedizin Berlin, Berlin Heart GmbH is carrying out the project "Ways to implement a cost-oriented VAD therapy II".

The aim of the project is further research in the field of mechanical circulatory support for the chronic treatment of terminal heart failure. Looking at the entire therapy chain, we strive to improve the interaction between the life-support system, patients and medical staff, as well as safe and cost-effective patient care after leaving the clinic.

The project is co-financed by the European Regional Development Fund (ERDF).

Commitment

What we stand for

As a medical technology company, we take responsibility not only for the quality of our products, but also for our patients and fellow human beings. Therefore, we are involved in projects that are particularly close to our hearts:

Ronald McDonald House Charities

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 absorbs the maintenance costs for an apartment. In addition, our employees get involved in a very personal way: with renovation campaigns, the weekly cooking evenings for the residents of the house or through specially arranged bake sales.

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 makes us want to draw attention to the 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.

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 possibilities.