Erbil patient set to receive experimental artificial heart in early rollout
Shafaq News- Erbil
A patient from Erbil, the capital of the Kurdistan Region of Iraq, is expected to be among the first recipients of the Realheart TAH, a fully implantable artificial heart currently in advanced preclinical development, Iraqi Kurdish cardiologist Azad Najar announced Wednesday at a press conference in Erbil.
Najar confirmed the rollout will follow a scheduled sequence. “The second recipient will be a Swedish citizen,” he said, without specifying the locations where the procedures will take place.
The Realheart TAH, developed by the Sweden-based company Scandinavian Real Heart AB, received a Humanitarian Use Device designation from the United States Food and Drug Administration in January 2025 —a preliminary regulatory classification that makes the device eligible to apply for a Humanitarian Device Exemption, an accelerated pathway that may grant limited authorization for use in rare, life-threatening cardiac conditions. The device has not received full FDA market approval.
Najar noted the device was developed to address complications associated with conventional cardiac treatments, particularly blood clotting, and incorporates a pumping mechanism designed to reduce risks linked to existing surgical options.
On pricing, he put the cost of the Realheart TAH at $120,000, according to a 2025 interview —a figure he described today as significantly lower than current treatment and surgical alternatives.
Background
Najar, a physician of Iraqi Kurdish origin from Zakho, has spent more than two decades developing the Realheart TAH through Scandinavian Real Heart AB, which he co-founded in 2007 and which is headquartered in Västerås, Sweden, where he has lived and worked for years. He previously served as chief physician in urology at Västmanlands hospital. Work on the device began independently in 1999, and the research team has since grown to between 30 and 50 full-time scientists and engineers.
The device is built on a four-chamber architecture designed to replicate the structure and blood-flow dynamics of the natural human heart, distinguishing it from existing artificial heart technologies that rely on continuous-flow pump mechanisms. Animal trials began in 2017, and successive prototype generations have been developed in collaboration with cardiac surgeons, including Professor Göran Dellgren of Sweden.
As of April 2026, a peer-reviewed study published in the journal Artificial Organs found the Realheart TAH produces approximately half the level of hemolysis, the mechanical destruction of red blood cells, compared to the only FDA-approved total artificial heart currently in clinical use. Scandinavian Real Heart AB is listed on Nasdaq Stockholm First North Growth Market.
