Berlin Heart

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]

History

'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

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).

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.^[9]
• In 2003, INCOR received CE approval after successfully completing the Multi-Center Study.^[10]
• In 2008, the INCOR patient Jean-Pierre Offe celebrated his five-year anniversary while on the system and therefore setting an INCOR world record.^[11] EXCOR Pediatric received unrestricted IDE Approval in the USA.^[12]
• In 2009, the 500th patient received INCOR VAD at the German Heart Institute.^[13]
• In 2011, EXCOR Pediatric received FDA approval for the U.S. market.^[14] The number of children who had been on EXCOR Pediatric reached over 1,000.^[15]
• In 2012, the longest support time of a toddler on EXCOR Pediatric reached 2.5 years.^[16]
• In 2013, the EXCOR Pediatric 15 ml blood pump received CE approval.
• In 2014, the 1,500th pediatric patient was supported by EXCOR Pediatric.^[17]

Studies

EXCOR Pediatric Prospective Trial of a Pediatric Ventricular Assist Device

The prospective, multicenter, single-arm study consisted of two cohorts, divided according to body surface area (BSA): cohort 1 BSA <0.7 m2, cohort 2 BSA >0.7 to <1.5 m2. Survival in the two cohorts was compared with survival in two propensity-score-matched historical control groups (one for each cohort, n=48) undergoing extracorporeal membrane oxygenation (ECMO) as a bridge to heart transplantation selected from the ELSO registry. The primary endpoint for the EXCOR Pediatric VAD was time to death or weaning with an unacceptable neurologic outcome, while the primary endpoint for the ECMO group was time to death (no data on neurologic status is available in the ELSO database). The Kaplan–Meier survival curves for EXCOR Pediatric patients were significantly better for each cohort when compared to their respective ECMO control group. Overall, for patients supported with EXCOR Pediatric VAD, 88% in cohort 1 and 92% in cohort 2 were bridged to transplant or recovery with acceptable neurological outcome.^[6]

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.

Literature

• Fraser et al., Prospective trial of a pediatric ventricular assist device. N Engl J Med. 2012; 367(6): 532-41.
• Engin, C. et al. Ventricular Assist Device as a Bridge to Heart Transplantation in Adults Transplant Proc. 2011 Apr: 43(3): 927-30.
• Jones, C. B. et al. Successful Bridge to Recovery with 120 Days of Mechanical Support in an Infant with Myocarditis. J Heart Lung Transplant. 2009: 28:202–5.
• Cassidy, J. et al. Changing Patterns of Bridging to Heart Transplantation in Children. J Heart Lung Transplant 2009 March: 28:249–54.
• Gandhi, S. K. et al. Beyond Berlin: Heart transplantation in the "untransplantable". J Thorac Cardiovasc Surg 2008 Nov.; 136: 529-531.
• Gandhi, S. K. et al. Biventricular Assist Devices as a Bridge to Heart Transplantation in Small Children Circulation 2008 Sep.: 118: 89-93.
• Schmid, C. et al. Influence of inflow cannula length in axial-flow pumps on neurologic adverse event rate: Results from a multi-center analysis. J Heart Lung Transplant 2008. 27; 3: 253-260.
• Hetzer, R. et al. First experiences with a novel magnetically suspended axial flow left ventricular assist device. Eur J Cardiothorac Surg 2004 25: 964-970.

References

1. Berlin Heart VAD. Texas Children’s Heart Center. Abgerufen am 25. Juni 2015.
2. Berlin Heart - History. Berlin Heart GmbH. Abgerufen am 25. Juni 2015.
3. 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.
4. Berlin Heart Incor Archived June 27, 2015, at the Wayback Machine.. MyLVAD. Abgerufen am 25. Juni 2015.
5. 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.
6. 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.
7. VADs in Children. Washington University School of Medicine in St. Louis. Abgerufen am 25. Juni 2015.
8. 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.
9. Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device. U.S. Food and Drug Administration. Abgerufen am 25. Juni 2015.
10. Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark. Business Wire. Abgerufen am 25. Juni 2015.
11. Heart Patient Living With Implantable Heart Support System for Five Years. PR Newswire. Abgerufen am 25. Juni 2015.
12. Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study Archived June 27, 2015, at the Wayback Machine.. Diagnostic and Interventional Cardiology. Abgerufen am 25. Juni 2015.
13. The History of the DHZB Archived June 27, 2015, at the Wayback Machine.. Deutsches Herzzentrum Berlin. Abgerufen am 25. Juni 2015.
14. Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). U.S. Food and Drug Administration. Abgerufen am 25. Juni 2015.
15. 1000th child to be supported with the Berlin Heart ventricular assist device. Berlin Heart GmbH. Abgerufen am 25. Juni 2015.
16. Longest support time with the EXCOR® Pediatric ventricular assist device. Berlin Heart GmbH. Abgerufen am 25. Juni 2015.
17. The 1,500th child supported by the Berlin Heart ventricular assist device has been transplanted. Open PR. Abgerufen am 25. Juni 2015.