Berlin Heart

{{Short description|German health company}} {{Infobox company | name = Berlin Heart | logo = | type = Limited liability company | industry = Ventricular assist devices | fate = | predecessor =  | successor =  | founded = 2000 | founder =  | defunct =  | hq_location_city = Berlin | hq_location_country = Germany | area_served =  | key_people = | products = | owner =  | num_employees = | num_employees_year =  | parent = | website =  }}

'''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.<ref>[http://www.texaschildrens.org/Berlin-Heart/ ''Berlin Heart VAD''] {{Webarchive|url=https://web.archive.org/web/20150627002753/http://www.texaschildrens.org/Berlin-Heart/ |date=2015-06-27 }}. Texas Children's Heart Center. Retrieved 25 June 2015.</ref>

== History == [[File:Skulptur Wiesenweg 10 (Lankw) Berlin Heart Bär.jpg|thumb|180px|'Buddy Bear Berlin Heart'<br /> 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.<ref name=":0">{{Cite web |date= |title=Deutsches Herzzentrum Berlin: Historie - Die Entwicklung des Deutschen Herzzentrums Berlin |url=https://www.dhzb.de/unternehmen/historie |access-date=2024-08-23 |website=www.dhzb.de}}</ref> This pioneering procedure was followed in 1990 by the first paediatric EXCOR implantation at the same institution.<ref name=":0" />

The company officially began operations as Mediport Kardiotechnik GmbH in 1996, established by the German Heart Institute Berlin and was supported by private investors.<ref>{{Cite news |date=1998-03-27 |title=Wirtschaft: Eine kleine Pumpe bringt Urlaub fürs Herz |url=https://www.tagesspiegel.de/wirtschaft/eine-kleine-pumpe-bringt-urlaub-furs-herz-568927.html |access-date=2024-08-23 |work=Der Tagesspiegel Online |language=de-DE |issn=1865-2263}}</ref> 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).<ref>[http://www.berlinheart.de/index.php/unternehmen/content/unternehmen_geschichte ''Berlin Heart - History'']. Berlin Heart GmbH. Retrieved 25 June 2015.</ref> The EXCOR Pediatric device received full premarket approval (PMA) in the U.S. in 2017.<ref>{{Cite web |date=2017-06-06 |title=U.S. Food & Drug Administration (FDA): Premarket Approval (PMA), EXCOR Pediatric Ventricular Assist Device |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P160035 |archive-url=https://web.archive.org/web/20170711080437/https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P160035 |url-status=dead |archive-date=July 11, 2017 |access-date=2024-08-23 |website=www.accessdata.fda.gov}}</ref> 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.<ref>{{Cite web |date=2020-02-19 |title=Neue Möglichkeiten für schwer herzkranke Kinder |url=https://www.berlinheart.de/mediaroom/pressemitteilungen/pressemitteilung/neue-moeglichkeiten-fuer-schwer-herzkranke-kinder/ |access-date=2024-08-23 |website=www.berlinheart.de |language=de-DE}}</ref>

== 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.<ref name="HetzerWeng2004">{{cite journal |last1=Hetzer |first1=R |last2=Weng |first2=Y |last3=Potapov |first3=E |last4=Pasic |first4=M |last5=Drews |first5=T |last6=Jurmann |first6=M |last7=Hennig |first7=E |last8=Muller |first8=J |title=First experiences with a novel magnetically suspended axial flow left ventricular assist device |journal=European Journal of Cardio-Thoracic Surgery |volume=25 |issue=6 |year=2004 |pages=964–970 |issn=1010-7940 |doi=10.1016/j.ejcts.2004.02.038|doi-access=free |pmid=15144996 }}</ref> The rotor in the pump has an active magnetic bearing while floating contact free.<ref>[http://mylvad.dev.digitalbungalow.com/lvad-devices/berlin-heart-incor ''Berlin Heart Incor''] {{webarchive |url=https://web.archive.org/web/20150627004716/http://mylvad.dev.digitalbungalow.com/lvad-devices/berlin-heart-incor |date=June 27, 2015 }}. MyLVAD. Retrieved 25 June 2015.</ref> 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.<ref name="SchmidJurmann2008">{{cite journal |last1=Schmid |first1=Christof |last2=Jurmann |first2=Michael |last3=Birnbaum |first3=Dietrich |last4=Colombo |first4=Tiziano |last5=Falk |first5=Volkmar |last6=Feltrin |first6=Giuseppe |last7=Garatti |first7=Andrea |last8=Genoni |first8=Michele |last9=Gerosa |first9=Gino |last10=Göttel |first10=Peter |last11=Gummert |first11=Jan |last12=Halfmann |first12=Robert |last13=Hammel |first13=Dieter |last14=Hennig |first14=Ewald |last15=Kaufmann |first15=Friedrich |last16=Lanfranconi |first16=Marco |last17=Meyns |first17=Bart |last18=Mohr |first18=Friedrich |last19=Müller |first19=Johannes |last20=Nikolov |first20=Dimitar |last21=Rucinskas |first21=Kestutis |last22=Scheld |first22=Hans-Heinrich |last23=Schmid |first23=Franz-Xaver |last24=Schneider |first24=Michael |last25=Sirvydis |first25=Vytautas |last26=Tandler |first26=René |last27=Vitali |first27=Ettore |last28=Vlasselaers |first28=Dirk |last29=Weyand |first29=Michael |last30=Wilhelm |first30=Markus |last31=Hetzer |first31=Roland |title=Influence of Inflow Cannula Length in Axial-flow Pumps on Neurologic Adverse Event Rate: Results From a Multi-center Analysis |journal=The Journal of Heart and Lung Transplantation |volume=27 |issue=3 |year=2008 |pages=253–260 |issn=1053-2498 |doi=10.1016/j.healun.2007.12.007|pmid=18342745 }}</ref>

'''EXCOR''' is a paracorporeal, pulsatile flow VAD.<ref name="FraserJaquiss2012">{{cite journal |last1=Fraser |first1=Charles D. |last2=Jaquiss |first2=Robert D.B. |last3=Rosenthal |first3=David N. |last4=Humpl |first4=Tilman |last5=Canter |first5=Charles E. |last6=Blackstone |first6=Eugene H. |last7=Naftel |first7=David C. |last8=Ichord |first8=Rebecca N. |last9=Bomgaars |first9=Lisa |last10=Tweddell |first10=James S. |last11=Massicotte |first11=M. Patricia |last12=Turrentine |first12=Mark W. |last13=Cohen |first13=Gordon A. |last14=Devaney |first14=Eric J. |last15=Pearce |first15=F. Bennett |last16=Carberry |first16=Kathleen E. |last17=Kroslowitz |first17=Robert |last18=Almond |first18=Christopher S. |title=Prospective Trial of a Pediatric Ventricular Assist Device |journal=New England Journal of Medicine |volume=367 |issue=6 |year=2012 |pages=532–541 |issn=0028-4793 |doi=10.1056/NEJMoa1014164 |pmid=22873533|doi-access=free }}</ref> The device provides left ventricular, right ventricular or biventricular assistance.<ref>[http://www.cardiothoracicsurgery.wustl.edu/en/Pediatric/Ventricular-Assist-Devices-in-Children ''VADs in Children''] {{Webarchive|url=https://web.archive.org/web/20150627001156/http://www.cardiothoracicsurgery.wustl.edu/en/Pediatric/Ventricular-Assist-Devices-in-Children |date=2015-06-27 }}. Washington University School of Medicine in St. Louis. Retrieved 25 June 2015.</ref> 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.<ref name="EnginAyik2011">{{cite journal |last1=Engin |first1=C. |last2=Ayik |first2=F. |last3=Oguz |first3=E. |last4=Eygi |first4=B. |last5=Yagdi |first5=T. |last6=Karakula |first6=S. |last7=Ozbaran |first7=M. |title=Ventricular Assist Device as a Bridge to Heart Transplantation in Adults |journal=Transplantation Proceedings |volume=43 |issue=3 |year=2011 |pages=927–930 |issn=0041-1345 |doi=10.1016/j.transproceed.2011.01.147|pmid=21486630 }}</ref> 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.<ref>{{Cite web|url=https://www.ksl.com/article/46427506/utah-toddler-flown-to-germany-for-rare-heart-surgery|title=Utah toddler flown to Germany for rare heart surgery|website=www.ksl.com|language=en|access-date=2018-12-14}}</ref> 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.<ref>{{Cite web|url=https://www.ksl.com/article/46427506/utah-toddler-flown-to-germany-for-rare-heart-surgery|title=Utah toddler flown to Germany for rare heart surgery|website=www.ksl.com|language=en|access-date=2018-12-14}}</ref><ref>{{Cite web|url=https://nachrichten.idw-online.de/2018/12/13/mit-kunstherz-ueber-den-atlantik/|title=Mit Kunstherz über den Atlantik|website=nachrichten.idw-online.de|access-date=2018-12-14}}</ref>

== Milestones ==

* In 1996, the EXCOR Stationary Driving Unit Ikus received CE approval. * In 1999, the EXCOR mobile driving unit received CE approval. * In 2000, the first child in the USA is supported by EXCOR Pediatric.<ref>[https://web.archive.org/web/20110819164810/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM263039.pdf ''Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device'']. U.S. Food and Drug Administration. Retrieved 25 June 2015.</ref> * In 2003, INCOR received CE approval after successfully completing the Multi-Center Study.<ref>[http://www.businesswire.com/news/home/20030508005418/en/Berlin-Heart-INCOR-Implanted-Blood-Pump-Carmeda#.VJlgGEPrA ''Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark'']. Business Wire. Retrieved 25 June 2015.</ref> * In 2008, the INCOR patient Jean-Pierre Offe celebrated his five-year anniversary while on the system and therefore setting an INCOR world record.<ref>[http://www.prnewswire.co.uk/news-releases/heart-patient-living-with-implantable-heart-support-system-for-five-years-154761605.html ''Heart Patient Living With Implantable Heart Support System for Five Years'']. PR Newswire. Retrieved 25 June 2015.</ref> EXCOR Pediatric received unrestricted IDE Approval in the USA.<ref>[http://www.dicardiology.com/article/berlin-hearts-excor-pediatric-vad-approved-ide-study ''Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study''] {{webarchive |url=https://web.archive.org/web/20150627001402/http://www.dicardiology.com/article/berlin-hearts-excor-pediatric-vad-approved-ide-study |date=June 27, 2015 }}. Diagnostic and Interventional Cardiology. Retrieved 25 June 2015.</ref> * In 2009, the 500th patient received INCOR VAD at the German Heart Institute.<ref>[http://www.dhzb.de/en/about_us/the_dhzb/history_of_the_dhzb ''The History of the DHZB''] {{webarchive |url=https://web.archive.org/web/20150627021529/http://www.dhzb.de/en/about_us/the_dhzb/history_of_the_dhzb |date=June 27, 2015 }}. Deutsches Herzzentrum Berlin. Retrieved 25 June 2015.</ref> * In 2011, EXCOR Pediatric received FDA approval for the U.S. market.<ref>[https://web.archive.org/web/20120605031109/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm302715.htm ''Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD)'']. U.S. Food and Drug Administration. Retrieved 25 June 2015.</ref> The number of children who had been on EXCOR Pediatric reached over 1,000.<ref>[http://www.berlinheart.de/UserFiles/File/pressemitteilungen-0103-file-PM_1_000ste_EXCOR_Pediatric_Implantation_2012_01_24_en.pdf ''1000th child to be supported with the Berlin Heart ventricular assist device'']. Berlin Heart GmbH. Retrieved 25 June 2015.</ref> * In 2012, the longest support time of a toddler on EXCOR Pediatric reached 2.5 years.<ref>[http://www.berlinheart.de/UserFiles/File/pressemitteilungen-0107-file-Longest_support_time_with_the_EXCOR_31.07.2012.pdf ''Longest support time with the EXCOR® Pediatric ventricular assist device'']. Berlin Heart GmbH. Retrieved 25 June 2015.</ref> * In 2013, the EXCOR Pediatric 15 ml blood pump received CE approval. * In 2014, the 1,500th pediatric patient was supported by EXCOR Pediatric.<ref>[http://www.openpr.com/news/309864/The-1-500th-child-supported-by-the-Berlin-Heart-ventricular-assist-device-has-been-transplanted.html ''The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted'']. Open PR. Retrieved 25 June 2015.</ref> * In 2017, Excor Pediatric receives full market approval (Premarket Approval, PMA) on the US market.<ref>{{Cite web |title=Premarket Approval (PMA) |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P160035 |archive-url=https://web.archive.org/web/20170711080437/https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P160035 |url-status=dead |archive-date=July 11, 2017 |access-date=2022-08-26 |website=www.accessdata.fda.gov}}</ref> * In 2019, The new mobile drive for the heart support system Excor, the Excor Active, receives the CE marking.<ref>{{Cite web |title=Neue Möglichkeiten für schwer herzkranke Kinder |url=https://www.berlinheart.de/mediaroom/pressemitteilungen/pressemitteilung/neue-moeglichkeiten-fuer-schwer-herzkranke-kinder/ |access-date=2022-08-26 |website=www.berlinheart.de |date=19 February 2020 |language=de-DE}}</ref>

== 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.

== References == {{reflist}}

Category:Medical technology companies of Germany Category:Companies established in 2000