Saturday, April 4, 2020
Breaking Medical Device Industry News

University of Helsinki and IRRAS Will Collaborate to Advance Uses of IRRAflow

Drs. Mika Niemelä and Behnam Rezai Jahromi Will Lead Efforts that Initially Focus on Treatment of Intraventricular Hemorrhage

Saturday, April 4, 2020

IRRAS has announced a long-term collaboration with Dr. Nika Niemela, Professor and Chairman of Neurosurgery, and Dr. Behnam Rezai Jahromi from the University of Helsinki, one of the world’s leading neurosurgical institutions, to utilize the company’s IRRAflow system in a variety of neurocritical applications. The initial area of focus will be in the treatment of patients suffering from intraventricular hemorrhage (IVH).

IRRAflow is the world’s first “irrigating intracranial drain,” and its unique mechanism of action addresses the complications associated with the current methods of managing intracranial fluid by using a dual-lumen catheter that combines automated irrigation, controlled drainage, and continuous ICP monitoring, all into one system. IRRAflow was introduced into the U.S. market in 2019 following the receipt of 510(k) clearance by the United States Food and Drug Administration (FDA) and is currently being reintroduced into the European Union (EU) after the recertification of the system’s CE Mark in December 2019.

“It is my belief that the system’s combination of automated irrigation and controlled drainage should contribute to better long-term outcomes for these critically ill patients, and I am excited to explore that hypothesis in greater detail,” said Dr. Mika Niemelä. “My early experience with the IRRAflow system has shown impressive acute results in draining collected toxic material out of the ventricles without catheter blockages,” said Dr. Rezai Jahromi.

Traditional treatment options for IVH patients generally utilize an External Ventricular Drainage (EVD) system, which is a passive approach that relies solely on gravity to facilitate drainage. Although an EVD is currently the most common treatment option for intracranial bleeding or elevated ICP, the technology is associated with several well-known complications such as catheter blockage, infections, and incomplete drainage. All of these complications can negatively impact patient outcome, which can subsequently increase the length of time needed in the hospital and the overall cost of care.

HUH Neurosurgery is world-famous for its expertise in all subsections of neurosurgery. It is considered the leading center in Europe in the microneurosurgical treatment of cerebral blood vessel diseases and complex brain tumors and is also ranked among the very best units in the world. Due to this reputation as one of the world’s leading centers in cerebrovascular problems, some of the most complex cases in the field are referred to Helsinki from other parts of the world. Each year, more than 3,200 patients undergo neurosurgical treatment at Helsinki, and nearly 200 neurosurgeons from all around the world visit the facility to learn the latest techniques in neurosurgery.

“This collaboration with Dr. Rezai Jahromi and the University of Helsinki represents an important component of our launch strategy for IRRAflow,” said Will Martin, Chief Commercial Officer of IRRAS. “There is a compelling need for transformative technologies, such as IRRAflow, to treat patients with intracranial bleeding, and we believe that this collaboration will advance the treatment of IVH and also accelerate the product’s awareness to a wider group of neurocritical care specialists.”

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