Berlin Heart GmbH is a German company that develops, produces and markets

ventricular assist device A ventricular assist device (VAD) is an electromechanics, electromechanical device that provides support for cardiac pump function, which is used either to partially or to completely replace the function of a failing heart. VADs can be used in p ...

s (VADs). The devices mechanically support the

heart The heart is a muscular Organ (biology), organ found in humans and other animals. This organ pumps blood through the blood vessels. The heart and blood vessels together make the circulatory system. The pumped blood carries oxygen and nutrie ...

s of patients with end-stage

heart failure Heart failure (HF), also known as congestive heart failure (CHF), is a syndrome caused by an impairment in the heart's ability to Cardiac cycle, fill with and pump blood. Although symptoms vary based on which side of the heart is affected, HF ...

. 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.

History

In 1987, the first EXCOR LVAD implantation was performed by Roland Hetzer at the German Heart Centre in Berlin. This pioneering procedure was followed in 1990 by the first paediatric EXCOR implantation at the same institution. The company officially began operations as Mediport Kardiotechnik GmbH in 1996, established by the German Heart Institute

Berlin Berlin ( ; ) is the Capital of Germany, capital and largest city of Germany, by both area and List of cities in Germany by population, population. With 3.7 million inhabitants, it has the List of cities in the European Union by population withi ...

and was supported by private investors. 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 Texas ( , ; or ) is the most populous U.S. state, state in the South Central United States, South Central region of the United States. It borders Louisiana to the east, Arkansas to the northeast, Oklahoma to the north, New Mexico to the we ...

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 (; ) is a type of Juridical person, legal entity in German-speaking countries. It is equivalent to a (Sàrl) in the Romandy, French-speaking region of Switzerland and to a (Sagl) in the Ticino, Italian-speaking region of Switzerland. It is a ...

). The EXCOR Pediatric device received full premarket approval (PMA) in the U.S. in 2017. 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.

Products

Berlin Heart manufactures two types of VADs: implantable and paracorporeal. INCOR is an

axial-flow pump An axial-flow pump, or AFP, is a common type of pump that essentially consists of a propeller (an axial impeller) in a pipe. The propeller can be driven directly by a sealed motor in the pipe or by electric motor or petrol/diesel engines mounte ...

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 A cannula (; Latin meaning 'little reed'; : cannulae or cannulas) is a tube that can be inserted into the body, often for the delivery or removal of fluid or for the gathering of samples. In simple terms, a cannula can surround the inner or out ...

. The

blood Blood is a body fluid in the circulatory system of humans and other vertebrates that delivers necessary substances such as nutrients and oxygen to the cells, and transports metabolic waste products away from those same cells. Blood is com ...

coming from the heart flows into the INCOR axial pump. The

rotor ROTOR was an elaborate air defence radar system built by the British Government in the early 1950s to counter possible attack by Soviet bombers. To get it operational as quickly as possible, it was initially made up primarily of WWII-era syst ...

in the pump has an active

magnetic bearing A magnetic bearing is a type of bearing that supports a load using magnetic levitation. Magnetic bearings support moving parts without physical contact. For instance, they are able to levitate a rotating shaft and permit relative motion with v ...

while floating contact free. 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. EXCOR is a paracorporeal, pulsatile flow VAD. The device provides left ventricular, right ventricular or biventricular assistance. The EXCOR system includes paracorporeal,

pneumatically Pneumatics (from Greek 'wind, breath') is the use of gas or pressurized air in mechanical systems. Pneumatic systems used in industry are commonly powered by compressed air or compressed inert gases. A centrally located and electrically- ...

-driven

polyurethane Polyurethane (; often abbreviated PUR and PU) is a class of polymers composed of organic chemistry, organic units joined by carbamate (urethane) links. In contrast to other common polymers such as polyethylene and polystyrene, polyurethane term ...

blood pumps. Each pump consists of a blood chamber and an air chamber which are separated by a multilayer flexible

membrane A membrane is a selective barrier; it allows some things to pass through but stops others. Such things may be molecules, ions, or other small particles. Membranes can be generally classified into synthetic membranes and biological membranes. Bi ...

. 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

valve A valve is a device or natural object that regulates, directs or controls the flow of a fluid (gases, liquids, fluidized solids, or Slurry, slurries) by opening, closing, or partially obstructing various passageways. Valves are technically Pip ...

s which ensure that the blood only flows in one direction. The blood pumps are connected to the heart and

blood vessel Blood vessels are the tubular structures of a circulatory system that transport blood throughout many Animal, animals’ bodies. Blood vessels transport blood cells, nutrients, and oxygen to most of the Tissue (biology), tissues of a Body (bi ...

s via

silicone In Organosilicon chemistry, organosilicon and polymer chemistry, a silicone or polysiloxane is a polymer composed of repeating units of siloxane (, where R = Organyl group, organic group). They are typically colorless oils or elastomer, rubber ...

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. 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.

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. * In 2003, INCOR received CE approval after successfully completing the Multi-Center Study. * In 2008, the INCOR patient Jean-Pierre Offe celebrated his five-year anniversary while on the system and therefore setting an INCOR world record. EXCOR Pediatric received unrestricted IDE Approval in the USA. * In 2009, the 500th patient received INCOR VAD at the German Heart Institute. * In 2011, EXCOR Pediatric received

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

approval for the U.S. market. The number of children who had been on EXCOR Pediatric reached over 1,000. * In 2012, the longest support time of a toddler on EXCOR Pediatric reached 2.5 years. * In 2013, the EXCOR Pediatric 15 ml blood pump received CE approval. * In 2014, the 1,500th pediatric patient was supported by EXCOR Pediatric. * In 2017, Excor Pediatric receives full market approval (Premarket Approval, PMA) on the US market. * In 2019, The new mobile drive for the heart support system Excor, the Excor Active, receives the CE marking.

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 The Woodlands is a Special district (United States), special-purpose district and census-designated place (CDP) in the U.S. state of Texas in the Greater Houston, Houston–The Woodlands–Sugar Land metropolitan statistical area. The Woodlands ...

, provides support for implanting centers in the United States and Canada.

References

{{Authority control Medical technology companies of Germany Companies established in 2000