Berlin Heart
Short answer: The Berlin Heart EXCOR Pediatric is a pulsatile, air-driven ventricular assist device (VAD) that keeps infants and children with severe heart failure alive, usually while they wait for a heart transplant.
It's paracorporeal: one or two blood pumps sit outside the body on the chest wall, connected by cannulas (tubes) through the skin to the heart's atrium or ventricle and to the great arteries. Each pump is a clear chamber split by a flexible membrane. A driving unit pushes and pulls air behind the membrane, so blood is drawn in and pushed out, and valves keep it flowing one way. Pumps come in small sizes for babies. The device grew out of the German Heart Institute Berlin. In 1990, its surgeons kept an 8-year-old boy alive on an adult-sized 50 mL pump until a transplant, and in 1992 an infant system with a 10 mL pump was implanted there for the first time. On December 16, 2011, the US FDA approved the EXCOR Pediatric under a Humanitarian Device Exemption as a bridge to transplant, after a 17-hospital study led by Texas Children's Hospital. The approved system uses the stationary Ikus driver. The smaller, battery-powered EXCOR Active driver weighs about 15 kg and runs at least 5 hours on batteries. In the US it's still an investigational device used under an FDA-approved study that began in November 2022. A 2026 JACC report found no major device malfunctions among its first 40 study patients. The footage shows a red blood pump with its connectors and a clear pump chamber lying on a hospital blanket.
In collections:Inside the Body
What should you know about Berlin Heart?
Quick facts. Each one stands alone and has a stable ID you can cite.
The Berlin Heart EXCOR's blood pumps sit outside the body and are driven by air pressure.
The FDA approved the Berlin Heart EXCOR Pediatric on December 16, 2011.
Video transcript: Berlin Heart: A Child's Heart Pump, Outside the Body
DID YOU KNOW? The Berlin Heart EXCOR® Pediatric is a life-saving ventricular assist device, or VAD, designed specifically for infants and children suffering from severe heart failure. Unlike implantable devices, the EXCOR® is paracorporeal, its blood pumps remain outside the body and are connected to the heart and major vessels via cannulae. These pumps are driven pneumatically by an external unit, such as the stationary Ikus, or the portable EXCOR® Active, which alternately applies positive and negative air pressure. NOW YOU KNOW!
Burned-in captions, read frame by frame (see transcript.md) · 26.3s Reel ·
The write-up
A child's heart pump, outside the body. Air pulses drive the Berlin Heart EXCOR's pumps, which sit outside the chest.
- Exhibit A
Pumps outside the body
The EXCOR's blood pumps sit outside the chest, connected to the heart and great arteries by cannulas.
- Exhibit B
Driven by air
Air pulses flex a membrane inside each pump, drawing blood in and pushing it out through one-way valves.
- Exhibit C
Born in Berlin
In 1990, Berlin surgeons bridged an 8-year-old to transplant with the device, and miniature pumps followed.
- Exhibit D
US approval
The FDA approved the EXCOR Pediatric on December 16, 2011, as a bridge to heart transplant.
- Exhibit E
A portable driver
The 15 kg EXCOR Active driver runs on batteries. In the US it's still in an FDA-approved study.
Questions people ask about Berlin Heart
Where do the EXCOR's blood pumps sit?
That's what paracorporeal means.
Source: Write-up · Exhibit A (Pumps outside the body) · FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011
What drives the EXCOR's pumps?
Air pulses flex a membrane in each pump.
Source: Write-up · Exhibit B (Driven by air) · FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011
In which city was the device first used to bridge a child to transplant?
At the German Heart Institute Berlin, in 1990.
Source: Write-up · Exhibit C (Born in Berlin) · Hetzer et al., 'Paediatric mechanical circulatory support with Berlin Heart EXCOR: development and outcome of a 23-year experience', European Journal of Cardio-Thoracic Surgery (2016)
When did the FDA approve the EXCOR Pediatric?
On December 16, 2011.
Source: Write-up · Exhibit D (US approval) · FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011; Texas Children's Hospital via PR Newswire: FDA approval of EXCOR Pediatric (December 16, 2011)
What is the EXCOR Active?
It runs on batteries for several hours.
Source: Write-up · Exhibit E (A portable driver) · Berlin Heart: EXCOR Active; ClinicalTrials.gov: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study (NCT05610787); JACC (2026): Prospective Multicenter Evaluation of a Novel Active Driving System for Pediatric Ventricular Assist Device Support
Test Your Knowledge
All quizzes →5 questions, all from this case file. Answers are revealed instantly.
Where do the EXCOR's blood pumps sit?
- Outside the body
- Inside the chest
- In the abdomen
- Inside the heart
Show the answer
Answer: A. Outside the body That's what paracorporeal means. Source: Write-up · Exhibit A (Pumps outside the body) · FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011
What drives the EXCOR's pumps?
- Air pressure
- Magnets
- A hand crank
- Springs
Show the answer
Answer: A. Air pressure Air pulses flex a membrane in each pump. Source: Write-up · Exhibit B (Driven by air) · FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011
In which city was the device first used to bridge a child to transplant?
- Berlin
- Houston
- Boston
- London
Show the answer
Answer: A. Berlin At the German Heart Institute Berlin, in 1990. Source: Write-up · Exhibit C (Born in Berlin) · Hetzer et al., 'Paediatric mechanical circulatory support with Berlin Heart EXCOR: development and outcome of a 23-year experience', European Journal of Cardio-Thoracic Surgery (2016)
When did the FDA approve the EXCOR Pediatric?
- 2011
- 1990
- 2001
- 2022
Show the answer
Answer: A. 2011 On December 16, 2011. Source: Write-up · Exhibit D (US approval) · FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011; Texas Children's Hospital via PR Newswire: FDA approval of EXCOR Pediatric (December 16, 2011)
What is the EXCOR Active?
- A portable driving unit
- A new blood pump
- An implantable heart
- A heart valve
Show the answer
Answer: A. A portable driving unit It runs on batteries for several hours. Source: Write-up · Exhibit E (A portable driver) · Berlin Heart: EXCOR Active; ClinicalTrials.gov: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study (NCT05610787); JACC (2026): Prospective Multicenter Evaluation of a Novel Active Driving System for Pediatric Ventricular Assist Device Support
Cite this case file
Easterling, Marcus. "Berlin Heart." The Detail Department (DetailEnjoyer), case file DD-577, last updated May 22, 2025. https://detailenjoyer.com/case/berlin-heart/
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