Berlin Heart

Berlin Heart
Name	Berlin Heart
Type	Private
Industry	Medical devices
Founded	1996
Founder	Dr. Heinz-Hermann Voss
Headquarters	Berlin, Germany
Products	EXCOR Pediatric, INCOR, EXCOR Adult

Berlin Heart Berlin Heart is a medical device company known for developing mechanical circulatory support systems, particularly ventricular assist devices used in pediatric and adult patients. The company produces paracorporeal and implantable pumps used as bridges to transplantation and recovery, collaborating with hospitals, research institutes, and regulatory agencies worldwide. Berlin Heart systems are used in tertiary care centers and specialize in support for congenital and acquired cardiac conditions.

Introduction

Berlin Heart devices are employed in specialized centers such as Charité – Universitätsmedizin Berlin, Great Ormond Street Hospital, Cleveland Clinic, Mayo Clinic, and Bambino Gesù Hospital for patients with end-stage heart failure or severe cardiomyopathy. The manufacturer interacts with regulators including the European Medicines Agency, U.S. Food and Drug Administration, and national health authorities in Germany, United Kingdom, and United States. Clinical use often involves multidisciplinary teams from institutions like Johns Hopkins Hospital, St. Jude Children’s Research Hospital, and Children’s Hospital of Philadelphia.

Device Design and Components

Berlin Heart systems include paracorporeal pumps such as the EXCOR series and implantable devices like INCOR. Components often referenced in clinical protocols include blood pumps, cannulae, pneumatic drivers, hydraulic bladders, artificial valves, and tubing sets manufactured to standards from organizations such as International Organization for Standardization and European Committee for Standardization. The EXCOR Pediatric system features interchangeable pump sizes compatible with surgical techniques practiced at centers like Texas Children’s Hospital and Hospital for Sick Children. Controller units may be used alongside devices from companies such as Abiomed and HeartWare in hybrid care pathways described in literature from Stanford Health Care and Massachusetts General Hospital.

Indications and Patient Selection

Indications for Berlin Heart support follow guidelines issued by societies like the American Heart Association, European Society of Cardiology, Pediatric Cardiac Society, and consensus statements from International Society for Heart and Lung Transplantation. Typical indications include refractory heart failure due to dilated cardiomyopathy, myocarditis, congenital heart disease, and acute decompensation after procedures at centers like Royal Brompton Hospital or Bristol Royal Hospital for Children. Patient selection involves multidisciplinary evaluation by teams including transplant services at UCLA Health, hemodynamic assessment units at Karolinska University Hospital, and genetic counseling services at Great Ormond Street Hospital for inherited cardiomyopathies.

Surgical Implantation and Management

Surgical implantation protocols reference techniques from cardiac surgery programs at University Hospital Freiburg, Mount Sinai Medical Center, Toronto General Hospital, and Sheba Medical Center. Cannulation strategies, anticoagulation regimens, and postoperative care follow pathways outlined by professional groups such as Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery. Postoperative management includes anticoagulation monitoring using assays developed in laboratories like those at University College London and infection control measures coordinated with departments at Karolinska University Hospital and Aarhus University Hospital. Rehabilitation and physical therapy interfaces involve collaboration with programs at Duke University Hospital and Johns Hopkins Hospital.

Outcomes and Complications

Reported outcomes appear in registries and trials coordinated with institutions such as INTERMACS, EuroELSO, and study groups at University of Oxford and University of Cambridge. Survival to transplant, myocardial recovery rates, and device-related adverse events have been published by teams at Vanderbilt University Medical Center, Emory University Hospital, and Yale New Haven Hospital. Complications include thromboembolism, hemorrhage, infection, and device malfunction that require management strategies described by specialists at Cleveland Clinic and Vienna General Hospital. Long-term follow-up is often performed through transplant centers like Hospital Universitario La Paz and pediatric networks coordinated by European Reference Network ERN-RND for neuromuscular and rare disease overlap.

History and Development

The company was founded in the late 1990s in Berlin with engineering contributions from academic groups at Technische Universität Berlin and collaborations with clinicians from Charité – Universitätsmedizin Berlin. Early clinical adoption involved pediatric cardiac units at Bambino Gesù Hospital and research partnerships with Max Planck Society. Regulatory milestones included CE marking and investigational device exemptions involving agencies such as the European Medicines Agency and U.S. Food and Drug Administration. Subsequent product iterations and clinical studies were reported by investigators from University College London, University of Pennsylvania, Heidelberg University Hospital, and Monash Health.

Category:Medical device manufacturers Category:Cardiac assist devices Category:Companies based in Berlin