Of children treated with the berlin heart excor device as a bridge to transplant, 29% experienced at least 1 neurological event. Continuous flow driven by a magnetically suspended axial flow rotor. The berlin heart excor pediatric device regulatory database was queried to identify all us children who received the berlin heart excor pediatric device between may 9, 2007 and december 31, 2010. Do not initiate cardiac support with the excor blood pumps until the. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support.
Berlin heart excor march 14th, 2005 medgadget editors cardiac surgery, pediatrics in an article by the associated press, we read about the berlin heart, an extracorporeal heart designed for. Fda summary of safety and effectiveness data page 6 ide clinical study a. The excor device has been approved by the food and drug administration fda with a pma. Berlin heart mechanical heart assist great ormond street. The excor is a pneumatically driven paracorporeal blood pump manufactured in 5 sizes. About berlin heart while only the excor pediatric is approved for use in the us, our products incor, excor adult and excor pediatric span the entire range of medical indications for patients of all ages from newborn babies to adults. Despite the improvement in ventricular assist device vad therapy in adults and in adolescents, in infant population only. Children aged 0 to 16 years with severe heart failure interagency registry for mechanically assisted circulatory support profile 1 or 2 due to 2ventricle heart disease and actively listed for ht comprise the primary study cohort. Transplant survival following berlin heart excor support. Excor is an integral part of an internationally active joint venture system with research and development centres in europe, asia and america. Berlin heart ensures production, delivery and service in times of corona customer letter march 2020 medical professionals for further information about our system excor pediatric. Berlin heart excor pediatric ventricular assist device in a.
The use of the berlin heart excor in patients with functional. Backgroundrecent data suggest that the berlin heart excor pediatric ventricular assist device is superior to extracorporeal membrane. It is a wellestablished lifesaving therapy for the bridge to heart transplant or to provide circulatory support in a transplanted patient. Complication profile of the berlin heart excor biventricular. Since 1990, the excor pediatric vad has been successfully used in increasing numbers at 166 pediatric heart centers in 37 countries. Pdf mechanical cardiac support in the young with the berlin.
Used on humanitarian approvals on a casebycase basis in the us. It is indicated for children with lifethreatening heart failure after all conservative therapeutic options have been exhausted. Instructions for use ifu our recommendation is to download the instructions for use, to print them if necessary and to read them carefully. The recommendations in this manual are based on berlin hearts. Use of berlin heart ventricular assist devices as a total. Cardiac graft survival after bridge to transplant with the berlin heart excor at texas childrens hospital tch was comparable to a national benchmark of pediatric heart transplant using the organ procurement and transplantation network optn. Here you can find news, pictures and videos from and about berlin heart. These happen very rarely, and the berlin heart has many backup systems and safety features to ensure the safety of the child should problems occur. We describe a 7yearold female caucasian child with classic sotos. Aug 31, 2019 berlin heart excor pediatric ventricular assist device is a mechanical circulatory support device currently used in pediatric patients.
Literature references relative to berlin heart excor pediatric. Pdf biventricular berlin heart excor pediatric use. Approval for the berlin heart excor pediatric ventricular assist device vad. Neurological injury was the leading cause of death after implantation of the berlin heart excor. Berlin heart executive summary update, 2016 pdf 504kb presentation. Biventricular berlin heart excor pediatric use across the. To our knowledge, argatroban has not been used for berlin heart excor vads in humans although lepirudin and danaparoid have been used with adult hit patients with lvads, 1 including one with a berlin heart excor vad. In addition, survival after vad explanation and cardiac transplantation is equivalent to patients receiving a transplant. Currently, the berlin heart excor is the only pediatricspecific device approved by the fda as a bridge to transplantation. Recent data suggest that the berlin heart excor pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Most common diagnosis requiring texas childrens hospital.
Pump exchanges are frequently required in the berlin heart excor vad. The berlin heart excor berlin heart ag, berlin, germany system consists of a paracorporeal, pneumatic compressoroperated diaphragm pump with polyurethane valves 10, 15, 25 or 30 ml stroke volume and silicon cannulae 8, 16, 17. Pdf clinical experience with berlin heart excor in. Biventricular assist device bivad support was a strong predictor of early mortality in the berlin heart excor pediatric investigational device exemption ide study assess safety and probable benefit of the excor pediatric ventricular assist device vad. This is equally important when it comes to effective vci corrosion protection provided by the packaging itself. Comparison of paracorporeal and continuous flow ventricular assist devices in children. The larger pumps 50, 60 and 80 ml are equipped with mechanical valves sorin, milan, italy. At excor, we are trailblazers in this field and have been marketing vci film for over 20 years. Patients with primary diastolic dysfunction are included in this study. Long term biventricular support with berlin heart excor in. Berlin heart excor pediatric ventricular assist device vad.
Prospective trial of a pediatric ventricular assist device. Disclosure forms provided by the authors are available with the. More than 1,700 excor pediatric patients have been implanted with the excor pediatric vad system and. Fulltext pdf berlin heart excor use in patients with congenital heart disease. Berlin heart excor pediatric was developed in conjunction with deutsches herzzentrum berlin, germany in the early 1990s, as a paracorporeal, pneumatically driven, pulsatile flow mechanical circulatory support device available in sizes virtually suitable for all children. The use of berlin heart excor vad in children less than 10 kg. Berlin heart gmbh, berlin, germany ventricular assist device vad as a bridge to transplant btt is commonplace. Berlin heart offers a comprehensive service plan for this system. Berlin heart excor ventricular assist device the annals of. The wide portfolio of pumps and cannulae allows berlin heart to meet the individual needs of each patient. This device is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Nine patients with a bvad excor system were treated between 2006 and 2012.
We intended to describe the characteristics of pump deposits in a larger patient series and evaluate if changes in our. Pdf first berlin heart excor pediatric vad interhospital. Safety of berlin heart excor pump changes in the picu. The berlin heart excor pediatric satisfies a large range of anatomical, clinical and practical requirements of vad therapy with an extensive portfolio of different size blood pumps and a wide selection of atrial, apex and arterial. Pump size of berlin heart excor pediatric device influences clinical outcome in children. Published data are limited to 1 in 4 children who received the device as part of the us clinical trial. American experience with the berlin heart excor berlin heart meditechnik gmbh, berlin, germany, morales and colleagues11 found 70% success as a bridge to transplant and 7% success as a bridge to recovery.
The excor system incorporates paracorporeal, pulsatile membrane pumps and implantable silicone cannulae. Supported by berlin heart and by a grant 1r01fd003557 from the food and drug administration office of orphan product development. Neurological complications and outcomes in the berlin heart. The paracorporeal vad is used for the short to longterm support of the left andor right ventricular pumping function. Outcomes of berlin heart excor pediatric ventricular assist. In adults, it has been identified that 5% to 10% of the vad population is benefited by bivad support over left ventricular assist device. Clinical experience with berlin heart excor in pediatric patients in argentina. The excor device has small pumps that can be used to support the left or right or both sides of the patients heart. Use of vads to support pediatric patients lags behind use to support adults, but experience is growing. Longterm results of berlin heart excor pediatric implantation in.
The use of the berlin heart excor in patients with functional single. Management of a pediatric patient on the berlin heart excor. We report our experience with the paracorporal berlin heart excor system berlin heart ag, berlin, germany used as a biventricuclar assist device bvad. The berlin heart excor pediatric ide study reported bivad support was a predictor of early mortality 32. Berlin heart excor pediatric ventricular assist device for. With reliable and globally successful products, berlin heart is one of the industrys market leaders. The berlin heart is a mechanical device, and as with any piece of machinery there is always the possibility that it will develop mechanical problems. A texas childrens hospital study demonstrated that cardiac support with the berlin heart excor is an effective therapy to bridge children to heart transplantation. External membrane pump device designed for children.
Below you will find instructions for use for clinics as well as for patients for all berlin heart products. One device is the berlin heart excor pediatric ventricular assist device or simply excor device. Berlin heart excor pediatric ventricular assist device. Paediatric mechanical circulatory support with berlin heart. Multilayer membrane rupture in a pediatric patient. Food and drug administration granted humanitarian device exemption approval of the berlin heart excor pediatric vad on december 16, 2011.
Excor is an extracorporeal pneumatically pulsatile ventricular assist device approved for use in pediatric age group since 2011 in the united. Berlin heart excor pediatric ventricular assist device for bridge to. Twenty pediatric patients with restrictive cardiomyopathy n, hypertrophic cardiomyopathy n 3, or congenital heart disease with restrictive physiology n 4 who were supported with excor were identified. Excor pediatric is a mechanical circulatory support system that provides. Berlin heart excor use in patients with congenital heart disease. The companys sales territory is growing, and alongside germany now includes austria, switzerland, spain, portugal, italy, romania, hungary, south africa and mexico. The berlin heart excor is a heart pump that maintains blood flow in babies and small children with serious heart failure. Devices are made that can possibly help a person whose heart function is not pumping enough blood to their body. Pump size of berlin heart excor pediatric device influences. Excor pediatric is designed for use in young patients, from newborns to adolescents. European studies suggested that excor pediatric can.
Persons with disabilities having problems accessing any of the pdf files below may call 2404023838 for assistance briefing materials berlin heart executive summary update, 2016. First berlin heart excor pediatric vad interhospital transports of nonambulatory patients with the ikus stationary driver. Excor adult is a mechanical, pulsatile heart support system. Literature references relative to berlin heart excor. Medical professionals excor pediatric berlin heart. Long term biventricular support with berlin heart excor in a. The pediatric berlin heart bh excor device provides mechanical circulatory support as a bridge to transplantation or recovery in children. Pdf the use of berlin heart excor vad in children less than. Bridge to recovery with berlin heart excor in children berlin heart excor vad. Pdf biventricular berlin heart excor pediatric use across. Berlin heart excor pediatric lvad paracorporeal means that the actual blood pumps are located outside of the body, and are connected to the heart and blood vessels via cannulas. The excor pediatric study data set was queried to identify all children in the united states who received the berlin heart excor pediatric device between may 9, 2007 and december 31, 2010.
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