Berlin Heart

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Berlin Heart
legal form GmbH
Seat Berlin , GermanyGermanyGermany 
management Sven-René Friedel, Ares K. Menon
Number of employees 228
sales 20.5 million euros
Branch Medical technology
Website www.berlinheart.de
Status: July 22, 2020

Berlin Heart GmbH develops, produces and sells systems for mechanical heart support, also known colloquially as artificial hearts. The EXCOR Adult and EXCOR Pediatric products can support patients of all ages and sizes, from babies to adults.

The company currently has 228 employees.

The systems are used for left, right or biventricular (bilateral) cardiac support. The EXCOR Pediatric product, specially developed for children, is the only cardiac support system worldwide that has been approved for pediatric VAD therapy.

* The availability of some or all of the products shown may be restricted due to country-specific approvals. The use of EXCOR VAD on adults, RVAD support, Excor mobil and EXCOR Active is not approved by the FDA.

history

1987: First EXCOR LVAD implantation at the German Heart Center in Berlin by Prof. Dr. Roland Hetzer .

1990: First pediatric EXCOR implantation at the German Heart Center in Berlin.

1996: Founding as Mediport Kardiotechnik GmbH by the German Heart Center Berlin and private investors

2000: Foundation of Berlin Heart AG through a merger with the predecessor company Mediport Kardiotechnik GmbH

2005: Foundation of the US subsidiary Berlin Heart Inc.

2006: Acquisition of Berlin Heart by a private investor and change of name to a GmbH

2017: EXCOR Pediatric receives full premarket approval (PMA) on the US market.

2019: The new mobile drive for the EXCOR cardiac support system, the EXCOR Active, receives the CE mark.

Product range

' Buddy Bär Berlin Heart ' in
front of the entrance to the head office at
Wiesenweg 10, 12247 Berlin

Berlin Heart's main product is EXCOR Adult , an artificial heart that has already been implanted more than 2,200 times. It is indicated in life-threateningly ill adults with severe heart failure after all conservative treatment options have been exhausted.

With EXCOR Pediatric , Berlin Heart has the only approved product that can be used as a cardiac support system for small children and infants. With the help of the system, a child was cared for for the first time in 1990 at the German Heart Center in Berlin. EXCOR Pediatric was first implanted in the USA by the Riley at IU Heals by means of a special decree of the FDA ( Food and Drug Administration ) from mid-December 2011, despite the lack of approval. The background was that the lack of approval for severely heart disease children in the USA prevented access to life-saving implants. The children's artificial heart triggered worldwide interest. Shortly thereafter, on December 16, 2011, EXCOR Pediatric received FDA approval.

In June 2014 EXCOR Pediatric was successfully implanted in a 12-day-old infant in Gateshead . Up until then, this was the youngest patient in the world to use an artificial heart. The infant died of medical complications a week later. In Australia, a 15-day-old girl was successfully treated with EXCOR Pediatric until the transplant. Also in 2014, a two-year-old girl in Toronto, Canada, was successfully supported with the system through to transplantation. In the meantime EXCOR Pediatric has also been used successfully with children in Japan, Argentina and Mexico. In total, more than 1,700 EXCOR Pediatric were implanted.

A study in the USA has shown that therapy with EXCOR® Pediatric significantly improves the chances of survival compared to conventional therapy (ECMO).

At the same time, Berlin Heart developed the first magnetically mounted, absolutely wear-free cardiac support pump (axial pump) INCOR , which is based on the principle of the Archimedean screw . Due to the freely stored screw, there is no friction or wear effect, which does not result in a replacement operation in the event of longer or permanent use. As the screw floats in the magnetic field without friction, this system transports blood without attacking the platelets in it. The medication with anticoagulants can be reduced accordingly.

Web links

Individual evidence

  1. ↑ Management
  2. ↑ a b Federal Gazette : Annual financial statements as of December 31, 2018
  3. ↑ Berlin Heart company website. Retrieved July 22, 2020 .
  4. ↑ Federal Gazette: Annual financial statements as of December 31, 2018. Retrieved on July 22, 2020 .
  5. ↑ You save children's lives. Frankfurter Allegemeine Zeitung, February 16, 2020, accessed on July 22, 2020 .
  6. ^ A b German Heart Center Berlin: History - The Development of the German Heart Center Berlin. Retrieved August 12, 2020 .
  7. ↑ Der Tagesspiegel: A small pump brings a vacation for the heart. March 26, 1998, accessed August 12, 2020 .
  8. ↑ Welt am Sonntag: Hearts that get by without a pulse. January 1, 2006, accessed August 12, 2020 .
  9. ↑ Berliner Morgenpost: Investor takes over Berlin Heart AG. October 14, 2006, accessed August 12, 2020 .
  10. ↑ US Food & Drug Administration (FDA): Premarket Approval (PMA), EXCOR Pediatric Ventricular Assist Device. June 6, 2017, accessed August 12, 2020 .
  11. ↑ Berlin Heart GmbH: New opportunities for children with severe heart problems. February 19, 2020, accessed August 12, 2020 .
  12. ^ Artificial hearts from Berlin all over the world Berliner Morgenpost
  13. ↑ Cosmopolitan city ​​with a heart Berliner Zeitung
  14. ↑ Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device SPONSOR EXECUTIVE SUMMARY Food and Drug Administration
  15. ↑ 30 years of artificial hearts - a Berlin success story  ( page no longer available , search in web archives )  Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. German Heart Center Berlin@1@ 2Template: Toter Link / www.dhzb.de  
  16. ↑ Riley Applaud's FDA Approval of Berlin Heart Device ( Memento of the original from October 6, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Riley Hospital for Children @1@ 2Template: Webachiv / IABot / iuhealth.org
  17. ↑ Excor pediatric obtained FDA approval ( Memento of the original from October 6, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , German Heart Center Berlin, February 2012  @1@ 2Template: Webachiv / IABot / www.dhzb.de
  18. ↑ Facebook bans fundraising page for sick baby awaiting heart transplant saying it's 'gory and evokes a negative response' dailymail.co.uk
  19. ^ El Gregorio Marañón hizo seis trasplantes en 24 hours el pasado 20 de agosto. Retrieved May 30, 2017 (Spanish).
  20. ↑ 2-month-old heart patient undergoes surgery ( Memento of the original from October 6, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. nbc12.com  @1@ 2Template: Webachiv / IABot / www.nbc12.com
  21. ↑ FDA Approves Mechanical Cardiac Assist Device for Children With Heart Failure US Food and Drug Administration
  22. ↑ Kate Proctor: Race to find 12-day-old baby a new heart as she becomes the youngest patient on transplant list. Daily Mirror , June 3, 2014, accessed October 1, 2014 .
  23. ↑ World's youngest 'Berlin Heart' baby dies in hospital www.thenorthernecho.co.uk
  24. ^ How tiny patients given the gift of life by Royal Children's Hospital cardiac team Sunday Herald Sun
  25. ↑ Berlin Heart technology helps kids waiting for heart transplants globalnews.ca
  26. ↑ T. Kakuta, T. Hoashi, H. Sakaguchi, K. Kagisaki, J. Negishi, M. Shimada, E. Tsuda, I. Shiraishi, N. Fukushima, H. Ichikawa: Early Single Institutional Experience of Berlin Heart EXCOR ( ®) Pediatric Ventricular Assist Device in Japan. In: Circulation journal: official journal of the Japanese Circulation Society. Volume 80, Number 12, November 2016, pp. 2552-2554, doi : 10.1253 / circj.CJ-16-0819 , PMID 27784856 .
  27. ↑ CONECTADAS Y ESPERANDO UN CORAZÓN DONATEHOY.COM
  28. ↑ Médicos mexicanos realizan primer implante de corazón artificial informador.com.mx
  29. ^ Artificial hearts from Berlin all over the world Berliner Morgenpost
  30. ^ Prospective Trial of a Pediatric Ventricular Assist Device, The New England Journal of Medicine
  31. ↑ Cardiac support pump modeled on the Archimedean screw
  32. ↑ Artificial Hearts German Heart Foundation