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]
In 1996, Mediport Kardiotechnik GmbH was founded by the German Heart Institute Berlin and was supported by private investors. Four years later, in 2000, Berlin Heart AG was founded after merging with its predecessor company, Mediport Kardiotechnik GmbH. The U.S. subsidiary, Berlin Heart Inc., was established in Texas in 2005. Due to a long-term private investor, Berlin Heart changed its legal structure in 2006 to a limited liability company (GmbH).[2]
Productsedit
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.[3] The rotor in the pump has an active magnetic bearing while floating contact free.[4] 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.[5]
EXCOR is a paracorporeal, pulsatile flow VAD.[6] The device provides left ventricular, right ventricular or biventricular assistance.[7] 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.[8] 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).
Triviaedit
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.[9] 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.[10][11]
Milestonesedit
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.[12]
In 2003, INCOR received CE approval after successfully completing the Multi-Center Study.[13]
In 2008, the INCOR patient Jean-Pierre Offe celebrated his five-year anniversary while on the system and therefore setting an INCOR world record.[14] EXCOR Pediatric received unrestricted IDE Approval in the USA.[15]
In 2009, the 500th patient received INCOR VAD at the German Heart Institute.[16]
In 2011, EXCOR Pediatric received FDA approval for the U.S. market.[17] The number of children who had been on EXCOR Pediatric reached over 1,000.[18]
In 2012, the longest support time of a toddler on EXCOR Pediatric reached 2.5 years.[19]
In 2013, the EXCOR Pediatric 15 ml blood pump received CE approval.
In 2014, the 1,500th pediatric patient was supported by EXCOR Pediatric.[20]
In 2017, Excor Pediatric receives full market approval (Premarket Approval, PMA) on the US market.[21]
In 2019, The new mobile drive for the heart support system Excor, the Excor Active, receives the CE marking.[22]
Locationsedit
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.
Referencesedit
^Berlin Heart VAD. Texas Children's Heart Center. Retrieved 25 June 2015.
^Berlin Heart - History. Berlin Heart GmbH. Retrieved 25 June 2015.
^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.
^Berlin Heart Incor June 27, 2015, at the Wayback Machine. MyLVAD. Retrieved 25 June 2015.
^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.
^VADs in Children 2015-06-27 at the Wayback Machine. Washington University School of Medicine in St. Louis. Retrieved 25 June 2015.
^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.
^"Utah toddler flown to Germany for rare heart surgery". www.ksl.com. Retrieved 2018-12-14.
^"Utah toddler flown to Germany for rare heart surgery". www.ksl.com. Retrieved 2018-12-14.
^"Mit Kunstherz über den Atlantik". nachrichten.idw-online.de. Retrieved 2018-12-14.
^Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device. U.S. Food and Drug Administration. Retrieved 25 June 2015.
^Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark. Business Wire. Retrieved 25 June 2015.
^Heart Patient Living With Implantable Heart Support System for Five Years. PR Newswire. Retrieved 25 June 2015.
^Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study June 27, 2015, at the Wayback Machine. Diagnostic and Interventional Cardiology. Retrieved 25 June 2015.
^The History of the DHZB June 27, 2015, at the Wayback Machine. Deutsches Herzzentrum Berlin. Retrieved 25 June 2015.
^Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). U.S. Food and Drug Administration. Retrieved 25 June 2015.
^1000th child to be supported with the Berlin Heart ventricular assist device. Berlin Heart GmbH. Retrieved 25 June 2015.
^Longest support time with the EXCOR® Pediatric ventricular assist device. Berlin Heart GmbH. Retrieved 25 June 2015.
^The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted. Open PR. Retrieved 25 June 2015.
^"Neue Möglichkeiten für schwer herzkranke Kinder". www.berlinheart.de (in German). 19 February 2020. Retrieved 2022-08-26.
January 01, 1970
berlin, heart, gmbh, german, company, that, develops, produces, markets, ventricular, assist, devices, vads, devices, mechanically, support, hearts, patients, with, stage, heart, failure, products, include, implantable, incor, paracorporeal, excor, date, produ. 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 Berlin HeartCompany typeLimited liability companyIndustryVentricular assist devicesFounded2000HeadquartersBerlin Germany Contents 1 History 2 Products 3 Trivia 4 Milestones 5 Locations 6 ReferencesHistory edit nbsp Buddy Bear Berlin Heart in front of the Head Office in Berlin In 1996 Mediport Kardiotechnik GmbH was founded by the German Heart Institute Berlin and was supported by private investors Four years later in 2000 Berlin Heart AG was founded after merging with its predecessor company Mediport Kardiotechnik GmbH The U S subsidiary Berlin Heart Inc was established in Texas in 2005 Due to a long term private investor Berlin Heart changed its legal structure in 2006 to a limited liability company GmbH 2 Products editBerlin 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 3 The rotor in the pump has an active magnetic bearing while floating contact free 4 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 5 EXCOR is a paracorporeal pulsatile flow VAD 6 The device provides left ventricular right ventricular or biventricular assistance 7 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 8 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 editIn 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 9 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 10 11 Milestones editIn 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 12 In 2003 INCOR received CE approval after successfully completing the Multi Center Study 13 In 2008 the INCOR patient Jean Pierre Offe celebrated his five year anniversary while on the system and therefore setting an INCOR world record 14 EXCOR Pediatric received unrestricted IDE Approval in the USA 15 In 2009 the 500th patient received INCOR VAD at the German Heart Institute 16 In 2011 EXCOR Pediatric received FDA approval for the U S market 17 The number of children who had been on EXCOR Pediatric reached over 1 000 18 In 2012 the longest support time of a toddler on EXCOR Pediatric reached 2 5 years 19 In 2013 the EXCOR Pediatric 15 ml blood pump received CE approval In 2014 the 1 500th pediatric patient was supported by EXCOR Pediatric 20 In 2017 Excor Pediatric receives full market approval Premarket Approval PMA on the US market 21 In 2019 The new mobile drive for the heart support system Excor the Excor Active receives the CE marking 22 Locations editBerlin 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 edit Berlin Heart VAD Texas Children s Heart Center Retrieved 25 June 2015 Berlin Heart History Berlin Heart GmbH Retrieved 25 June 2015 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 Berlin Heart Incor Archived June 27 2015 at the Wayback Machine MyLVAD Retrieved 25 June 2015 Schmid Christof Jurmann Michael Birnbaum Dietrich Colombo Tiziano Falk Volkmar Feltrin Giuseppe Garatti Andrea Genoni Michele Gerosa Gino Gottel Peter Gummert Jan Halfmann Robert Hammel Dieter Hennig Ewald Kaufmann Friedrich Lanfranconi Marco Meyns Bart Mohr Friedrich Muller Johannes Nikolov Dimitar Rucinskas Kestutis Scheld Hans Heinrich Schmid Franz Xaver Schneider Michael Sirvydis Vytautas Tandler Rene 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 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 VADs in Children Archived 2015 06 27 at the Wayback Machine Washington University School of Medicine in St Louis Retrieved 25 June 2015 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 Utah toddler flown to Germany for rare heart surgery www ksl com Retrieved 2018 12 14 Utah toddler flown to Germany for rare heart surgery www ksl com Retrieved 2018 12 14 Mit Kunstherz uber den Atlantik nachrichten idw online de Retrieved 2018 12 14 Berlin Heart Inc EXCOR Pediatric Ventricular Assist Device U S Food and Drug Administration Retrieved 25 June 2015 Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark Business Wire Retrieved 25 June 2015 Heart Patient Living With Implantable Heart Support System for Five Years PR Newswire Retrieved 25 June 2015 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 The History of the DHZB Archived June 27 2015 at the Wayback Machine Deutsches Herzzentrum Berlin Retrieved 25 June 2015 Berlin Heart EXCOR Pediatric Ventricular Assist Device VAD U S Food and Drug Administration Retrieved 25 June 2015 1000th child to be supported with the Berlin Heart ventricular assist device Berlin Heart GmbH Retrieved 25 June 2015 Longest support time with the EXCOR Pediatric ventricular assist device Berlin Heart GmbH Retrieved 25 June 2015 The 1 500th child supported by the Berlin Heart ventricular assist device has been transplanted Open PR Retrieved 25 June 2015 Premarket Approval PMA www accessdata fda gov Retrieved 2022 08 26 Neue Moglichkeiten fur schwer herzkranke Kinder www berlinheart de in German 19 February 2020 Retrieved 2022 08 26 Retrieved from https en wikipedia org w index php title Berlin Heart amp oldid 1217591323, wikipedia, wiki, book, books, library,
