Berlin Heart

Last updated
Berlin Heart
Company typeLimited liability company
IndustryVentricular assist devices
Founded2000
Headquarters
Berlin
,
Germany

Berlin Heart GmbH is a German company that develops, produces and markets ventricular assist devices (VADs). The devices mechanically support the hearts of patients with end-stage heart failure. Berlin Heart's products include the implantable INCOR VAD and the paracorporeal EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure. [1]

Contents

History

'Buddy Bear Berlin Heart' in front of the Head Office in Berlin Skulptur Wiesenweg 10 (Lankw) Berlin Heart Bar.jpg
'Buddy Bear Berlin Heart'
in front of the Head Office in Berlin

In 1987, the first EXCOR LVAD implantation was performed by Roland Hetzer at the German Heart Centre in Berlin. [2] This pioneering procedure was followed in 1990 by the first paediatric EXCOR implantation at the same institution. [2]

The company officially began operations as Mediport Kardiotechnik GmbH in 1996, established by the German Heart Institute Berlin and was supported by private investors. [3] Four years later, in 2000, Mediport Kardiotechnik merged with its predecessor company, Mediport Kardiotechnik GmbH to form Berlin Heart AG.

The expansion continued with the establishment of a U.S. subsidiary, Berlin Heart Inc., in Texas in 2005.

A significant change occurred in 2006, when a private investor acquired Berlin Heart and changed its legal structure in 2006 to a limited liability company (GmbH). [4] The EXCOR Pediatric device received full premarket approval (PMA) in the U.S. in 2017. [5] Most recently, the EXCOR Active, a new mobile drive for the EXCOR ventricular assist device, was granted CE marking, affirming its compliance with European health, safety, and environmental standard. [6]

Products

Berlin Heart manufactures two types of VADs: implantable and paracorporeal.

INCOR is an axial-flow pump for support of the left ventricle. In this system, the pump is implanted directly next to the heart and is connected to the heart by cannula. The blood coming from the heart flows into the INCOR axial pump. [7] The rotor in the pump has an active magnetic bearing while floating contact free. [8] Due to the rotation, up to eight liters of blood per minute are continuously pumped through the body. A percutaneous driveline connects the pump with the external controller. The control unit and the two batteries are carried in a shoulder-bag. [9]

EXCOR is a paracorporeal, pulsatile flow VAD. [10] The device provides left ventricular, right ventricular or biventricular assistance. [11] The EXCOR system includes paracorporeal, pneumatically-driven polyurethane blood pumps. Each pump consists of a blood chamber and an air chamber which are separated by a multilayer flexible membrane. [12] The movement of air in and out of the air chamber is controlled by a driving unit. It moves the membranes, which draw blood into the blood chamber and push it back into the body. Like the heart, EXCOR blood pumps have valves which ensure that the blood only flows in one direction. The blood pumps are connected to the heart and blood vessels via silicone cannula.

The EXCOR product range covers blood pumps and cannula of various sizes and types. While EXCOR Adult is specifically designed for adults, EXCOR Pediatric includes devices for young patients (from newborns to adolescents).

Trivia

In 2018 Chloe Caldwell became the first pediatric patient to be flown for a medical treatment from the United States to Germany. Caldwell had been implanted a VAD manufactured by Berlin Heart after severe heart problems. [13] A team of doctors at the Berlin's Deutsches Herzzentrum Berlin (DHZB) removed the VAD successfully and she is expected to make a full recovery, without the need of a heart transplant. [14] [15]

Milestones

Locations

Berlin Heart's headquarters is in Berlin, Germany, where all products and equipment are also manufactured. The wholly owned Berlin Heart, Inc. in the Woodlands, Texas, provides support for implanting centers in the United States and Canada.

Related Research Articles

<span class="mw-page-title-main">Artificial heart</span> Mechanical device which replaces the heart

An artificial heart is an artificial organ device that replaces the heart. Artificial hearts are typically used to bridge the time to complete heart transplantation surgery, but research is ongoing to develop a device that could permanently replace the heart in the case that a heart transplant is unavailable or not viable. As of December 2023, there are two commercially available full artificial heart devices; in both cases, they are for temporary use, of less than a year, for total heart failure patients awaiting a human heart to be transplanted into their bodies.

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<span class="mw-page-title-main">Extracorporeal membrane oxygenation</span> Technique of providing both cardiac and respiratory support

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AbioCor was a total artificial heart (TAH) developed by the Massachusetts-based company AbioMed. It was fully implantable within a patient, due to a combination of advances in miniaturization, biosensors, plastics and energy transfer. The AbioCor ran on a rechargeable source of power. The internal battery was charged by a transcutaneous energy transmission (TET) system, meaning that no wires or tubes penetrated the skin, reducing the risk of infection. However, because of its size, this heart was only compatible with men who had a large frame. It had a product life expectancy of 18 months.

<span class="mw-page-title-main">Ventricular assist device</span> Medical device to assist or replace a heart

A ventricular assist device (VAD) is an electromechanical device that provides support for cardiac pump function, which is used either to partially or to completely replace the function of a failing heart. VADs can be used in patients with acute or chronic heart failure, which can occur due to coronary artery disease, atrial fibrillation, valvular disease, and other conditions.

William S. Pierce is an American cardiothoracic surgeon and chemical engineer who led development of the first pneumatic heart assist pump. The Pierce-Donachy Ventricular Assist Device, also known as the Penn State Assist Pump, was designated an International Historic Mechanical Engineering Landmark by the American Society of Mechanical Engineers in 1990.

Abiomed, Inc. is a medical device technology company that operates as a stand-alone business within Johnson & Johnson's MedTech Segment. Abiomed develops and manufactures temporary external and implantable mechanical circulatory support devices. The company is headquartered in Danvers, Massachusetts with additional offices in Woburn, Baltimore, Berlin, Aachen, and Tokyo.

Cardiothoracic anesthesiology is a subspeciality of the medical practice of anesthesiology, devoted to the preoperative, intraoperative, and postoperative care of adult and pediatric patients undergoing cardiothoracic surgery and related invasive procedures.

Adrian Kantrowitz was an American cardiac surgeon whose team performed the world's second heart transplant attempt at Maimonides Medical Center in Brooklyn, New York on December 6, 1967. The infant lived for only six hours. At a press conference afterwards, Kantrowitz emphasized that he considered the operation to have been a failure.

A wearable cardioverter defibrillator (WCD) is a non-invasive, external device for patients at risk of sudden cardiac arrest (SCA). It allows physicians time to assess their patient's arrhythmic risk and see if their ejection fraction improves before determining the next steps in patient care. It is a leased device. A summary of the device, its technology and indications was published in 2017 and reviewed by the EHRA Scientific Documents Committee.

The Hemopump was designed to allow for temporary support of a failing heart. It is a continuous flow pump, and does not need to be synced to the rhythm of the heart. It assists in temporary heart stimulation with conditions such as cardiogenic shock following acute myocardial infarction, heart failure from cardiopulmonary bypass, and more. The pump can continually monitor the left ventricle, which allows for perpetual observation of the hearts condition. This allows for any necessary changes to be made when needed. The pump operates at speeds between two hundred and ninety and four hundred and seventy revolutions per minute.

Destination therapy is a therapy that is final rather than being a transitional stage until another therapy—thus, in transportation metaphor, a destination in itself rather than merely a bridge or road to the destination. The term usually refers to ventricular assist devices or mechanical circulatory support to keep the existing heart going, not just until a heart transplant can occur, but for the rest of the patient's life expectancy. It is thus a course of treatment for severe heart failure patients who are not likely candidates for transplant. In contrast, bridge-to-transplant therapy is a way to stay alive long enough, and stay healthy enough, to await transplant while maintaining eligibility for transplant.

Thoratec Corporation is a United States-based company that develops, manufactures, and markets proprietary medical devices used for mechanical circulatory support for the treatment of heart-failure patients worldwide. It is a global leader in mechanical circulatory support devices, particularly in ventricular assist devices (VADs).

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Charles D Fraser, Jr. is the medical director and surgeon of the Texas Center for Pediatric and Congenital Heart Disease at Dell Children's Medical Center. Formerly, Fraser was chief of congenital heart surgery and cardiac surgeon-in-charge at Texas Children's Hospital, the nation's largest pediatric hospital, served as chief of the Congenital Heart Surgery Division at Baylor College of Medicine, and director of the Adult Congenital Heart Surgery Program at the Texas Heart Institute.

William F. Bernhard was an American cardiovascular surgeon, Emeritus Professor of Surgery at Harvard Medical School, and cardiovascular surgical pioneer.

James K. Kirklin is an American cardiac surgeon who has made significant scientific and surgical contributions in the fields of heart transplantation and mechanical circulatory support devices to assist the pumping action of the heart. He was formerly Professor of Surgery (1987-2022), Director of the Division of Cardiothoracic Surgery (2006-2016), Director of the James and John Kirklin Institute for Research in Surgical Outcomes (KIRSO) (2016–2022), and Co-Director of Comprehensive Cardiovascular Center (2011-2017) at the University of Alabama at Birmingham (UAB). While at UAB, he held the UAB Cardiovascular Research Chair (1998-2006), the John Kirklin Chair of Cardiovascular Surgery (2006-2017), and the James Kirklin Chair of Cardiothoracic Surgery (2017-2022).

ReliantHeart, Inc. is a privately held American company headquartered in Houston, Texas that designs, manufactures, and provides remote monitoring capabilities for its left ventricular assist devices which are used to assist circulation for failing hearts.

Pump thrombosis (PT) is considered a specific case of a major device malfunction, and is classified as either suspected or confirmed pump thrombus. Typically, the device is an implanted blood pump such as a left ventricular assist device. The malfunction is a blockage in the flow of blood anywhere along a vessel and it is mainly due to the bio-incompatible presence of a fairly complex mechanical apparatus. Pump thrombus is dreaded complication of CF LVAD technology that can require repeat surgery to replace the pump or lead to death.

Eric A. Rose is an American cardiothoracic surgeon, scientist, entrepreneur and professor and Chairman of the Department of Population Health Science & Policy, and Associate Director for Clinical Outcomes at Mount Sinai Heart. He is best known for performing the first successful paediatric heart transplant, in 1984 while at NewYork–Presbyterian Hospital (NYP).

References

  1. ↑ Berlin Heart VAD. Texas Children's Heart Center. Retrieved 25 June 2015.
  2. 1 2 "Deutsches Herzzentrum Berlin: Historie - Die Entwicklung des Deutschen Herzzentrums Berlin". www.dhzb.de. Retrieved 2024-08-23.
  3. ↑ "Wirtschaft: Eine kleine Pumpe bringt Urlaub fürs Herz". Der Tagesspiegel Online (in German). 1998-03-27. ISSN   1865-2263 . Retrieved 2024-08-23.
  4. ↑ Berlin Heart - History. Berlin Heart GmbH. Retrieved 25 June 2015.
  5. ↑ "U.S. Food & Drug Administration (FDA): Premarket Approval (PMA), EXCOR Pediatric Ventricular Assist Device". www.accessdata.fda.gov. 2017-06-06. Retrieved 2024-08-23.
  6. ↑ "Neue Möglichkeiten für schwer herzkranke Kinder". www.berlinheart.de (in German). 2020-02-19. Retrieved 2024-08-23.
  7. ↑ Hetzer, R; Weng, Y; Potapov, E; Pasic, M; Drews, T; Jurmann, M; Hennig, E; Muller, J (2004). "First experiences with a novel magnetically suspended axial flow left ventricular assist device". European Journal of Cardio-Thoracic Surgery. 25 (6): 964–970. doi: 10.1016/j.ejcts.2004.02.038 . ISSN   1010-7940. PMID   15144996.
  8. ↑ Berlin Heart Incor Archived June 27, 2015, at the Wayback Machine . MyLVAD. Retrieved 25 June 2015.
  9. ↑ Schmid, Christof; Jurmann, Michael; Birnbaum, Dietrich; Colombo, Tiziano; Falk, Volkmar; Feltrin, Giuseppe; Garatti, Andrea; Genoni, Michele; Gerosa, Gino; Göttel, Peter; Gummert, Jan; Halfmann, Robert; Hammel, Dieter; Hennig, Ewald; Kaufmann, Friedrich; Lanfranconi, Marco; Meyns, Bart; Mohr, Friedrich; Müller, Johannes; Nikolov, Dimitar; Rucinskas, Kestutis; Scheld, Hans-Heinrich; Schmid, Franz-Xaver; Schneider, Michael; Sirvydis, Vytautas; Tandler, René; Vitali, Ettore; Vlasselaers, Dirk; Weyand, Michael; Wilhelm, Markus; Hetzer, Roland (2008). "Influence of Inflow Cannula Length in Axial-flow Pumps on Neurologic Adverse Event Rate: Results From a Multi-center Analysis". The Journal of Heart and Lung Transplantation. 27 (3): 253–260. doi:10.1016/j.healun.2007.12.007. ISSN   1053-2498. PMID   18342745.
  10. ↑ Fraser, Charles D.; Jaquiss, Robert D.B.; Rosenthal, David N.; Humpl, Tilman; Canter, Charles E.; Blackstone, Eugene H.; Naftel, David C.; Ichord, Rebecca N.; Bomgaars, Lisa; Tweddell, James S.; Massicotte, M. Patricia; Turrentine, Mark W.; Cohen, Gordon A.; Devaney, Eric J.; Pearce, F. Bennett; Carberry, Kathleen E.; Kroslowitz, Robert; Almond, Christopher S. (2012). "Prospective Trial of a Pediatric Ventricular Assist Device". New England Journal of Medicine. 367 (6): 532–541. doi: 10.1056/NEJMoa1014164 . ISSN   0028-4793. PMID   22873533.
  11. ↑ VADs in Children Archived 2015-06-27 at the Wayback Machine . Washington University School of Medicine in St. Louis. Retrieved 25 June 2015.
  12. ↑ Engin, C.; Ayik, F.; Oguz, E.; Eygi, B.; Yagdi, T.; Karakula, S.; Ozbaran, M. (2011). "Ventricular Assist Device as a Bridge to Heart Transplantation in Adults". Transplantation Proceedings. 43 (3): 927–930. doi:10.1016/j.transproceed.2011.01.147. ISSN   0041-1345. PMID   21486630.
  13. ↑ "Utah toddler flown to Germany for rare heart surgery". www.ksl.com. Retrieved 2018-12-14.
  14. ↑ "Utah toddler flown to Germany for rare heart surgery". www.ksl.com. Retrieved 2018-12-14.
  15. ↑ "Mit Kunstherz über den Atlantik". nachrichten.idw-online.de. Retrieved 2018-12-14.
  16. ↑ Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device. U.S. Food and Drug Administration. Retrieved 25 June 2015.
  17. ↑ Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark. Business Wire. Retrieved 25 June 2015.
  18. ↑ Heart Patient Living With Implantable Heart Support System for Five Years. PR Newswire. Retrieved 25 June 2015.
  19. ↑ Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study Archived June 27, 2015, at the Wayback Machine . Diagnostic and Interventional Cardiology. Retrieved 25 June 2015.
  20. ↑ The History of the DHZB Archived June 27, 2015, at the Wayback Machine . Deutsches Herzzentrum Berlin. Retrieved 25 June 2015.
  21. ↑ Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). U.S. Food and Drug Administration. Retrieved 25 June 2015.
  22. ↑ 1000th child to be supported with the Berlin Heart ventricular assist device. Berlin Heart GmbH. Retrieved 25 June 2015.
  23. ↑ Longest support time with the EXCOR® Pediatric ventricular assist device. Berlin Heart GmbH. Retrieved 25 June 2015.
  24. ↑ The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted. Open PR. Retrieved 25 June 2015.
  25. ↑ "Premarket Approval (PMA)". www.accessdata.fda.gov. Retrieved 2022-08-26.
  26. ↑ "Neue Möglichkeiten für schwer herzkranke Kinder". www.berlinheart.de (in German). 19 February 2020. Retrieved 2022-08-26.


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