# Berlin Heart (DD-577)

> 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.

- Department: Science (also Tech)
- First published: 2025-05-22
- Last updated: 2025-05-22
- Permalink: https://detailenjoyer.com/case/berlin-heart/
- Author: Marcus Easterling (DetailEnjoyer), The Detail Department

## On the timeline

- **1990**: Berlin surgeons bridge an 8-year-old to heart transplant with the EXCOR
- **1992**: An infant system with a 10 mL pump is first implanted in Berlin
- **Dec. 16, 2011**: The FDA approves the EXCOR Pediatric under a Humanitarian Device Exemption
- **November 2022**: The US study of the EXCOR Active driver begins

Full timeline: https://detailenjoyer.com/timeline/?case=berlin-heart

## Quick facts

- **DD-577-F01**: The Berlin Heart EXCOR's blood pumps sit outside the body and are driven by air pressure. _(Write-up · Exhibit A (Pumps outside the body))_
- **DD-577-F02**: The FDA approved the Berlin Heart EXCOR Pediatric on December 16, 2011. _(Write-up · Exhibit D (US approval))_

## Write-up

A child's heart pump, outside the body. Air pulses drive the Berlin Heart EXCOR's pumps, which sit outside the chest.

1. **Pumps outside the body**: The EXCOR's blood pumps sit outside the chest, connected to the heart and great arteries by cannulas.
2. **Driven by air**: Air pulses flex a membrane inside each pump, drawing blood in and pushing it out through one-way valves.
3. **Born in Berlin**: In 1990, Berlin surgeons bridged an 8-year-old to transplant with the device, and miniature pumps followed.
4. **US approval**: The FDA approved the EXCOR Pediatric on December 16, 2011, as a bridge to heart transplant.
5. **A portable driver**: The 15 kg EXCOR Active driver runs on batteries. In the US it's still in an FDA-approved study.

## Related case files

- [Blood Watch (DD-649)](https://detailenjoyer.com/case/blood-watch/): Another look at blood moving through the body
- [Peristaltic Pumps (DD-689)](https://detailenjoyer.com/case/peristaltic-pumps/): Another pump that moves fluid without touching it
- [I Wanted You to Know... (DD-265)](https://detailenjoyer.com/case/i-wanted-you-to-know/): I linked more on the heart
- [An MRI's Skeleton (DD-290)](https://detailenjoyer.com/case/an-mris-skeleton/): I linked more hospital machinery

## Reel vs. record

- **Note**: 'Designed specifically for infants and children': the pediatric pumps were. The first child, in 1990, was supported with an adult-sized 50 mL pump, and miniature pumps (from 10 mL) followed. It's mainly a bridge to heart transplant.
- **Note**: 'Such as the stationary Ikus, or the portable EXCOR® Active': both drivers exist, but their status differs by country. In the US, the Ikus is the FDA-approved driver, and EXCOR Active is still an investigational device used in an FDA-approved study. Berlin Heart says both are for use in healthcare facilities.
- **Note**: 'Applies positive and negative air pressure': correct. The air pushes and pulls a flexible membrane inside each pump, and valves keep the blood flowing one way.
- **Missing**: the FDA approved the EXCOR Pediatric under a Humanitarian Device Exemption on December 16, 2011, after a 17-hospital US study led by Texas Children's Hospital.

## Video: Berlin Heart: A Child's Heart Pump, Outside the Body

- Duration: 26.3 s · Published: 2025-05-22
- File: https://detailenjoyer.com/assets/videos/DJ9lmBuxUbJ.mp4

### Transcript

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!

## Questions & answers

**Q: Where do the EXCOR's blood pumps sit?**  
A: 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)_

**Q: What drives the EXCOR's pumps?**  
A: 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)_

**Q: In which city was the device first used to bridge a child to transplant?**  
A: 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))_

**Q: When did the FDA approve the EXCOR Pediatric?**  
A: 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))_

**Q: What is the EXCOR Active?**  
A: 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)_

## Sources

- [FDA: HDE approval letter and summary, Berlin Heart EXCOR Pediatric VAD (H100004), December 16, 2011](https://www.accessdata.fda.gov/cdrh_docs/pdf10/h100004a.pdf)
- [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)](https://doi.org/10.1093/ejcts/ezw011)
- [Texas Children's Hospital via PR Newswire: FDA approval of EXCOR Pediatric (December 16, 2011)](https://www.prnewswire.com/news-releases/texas-childrens-hospital-lead-study-center-announces-us-food-and-drug-administration-approval-of-excor-pediatric-ventricular-assist-device-for-use-in-united-states-132801873.html)
- [Berlin Heart: EXCOR Active](https://www.berlinheart.de/en/medical-professionals/excorr-active/)
- [ClinicalTrials.gov: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study (NCT05610787)](https://clinicaltrials.gov/study/NCT05610787)
- [JACC (2026): Prospective Multicenter Evaluation of a Novel Active Driving System for Pediatric Ventricular Assist Device Support](https://www.jacc.org/doi/10.1016/j.jacc.2026.03.080)

## 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/