Gambro and Novalung are joining forces to introduce a new therapy to the intensive care unit (ICU). Many ICU patients are critically ill and frequently depend on organ support, such as mechanical ventilation or continuous renal replacement therapy (CRRT). Gambro's PrismaFlex is a widely used platform for all continuous renal replacement modalities as well as liver support. The partnership will integrate Novalung's membrane gas exchange technology into the Prismaflex platform, adding carbon dioxide (CO2) removal to its therapeutic offering. Simple and reliable CO2 removal integrated in a well established blood purification platform is an unmet medical need in the ICU. It facilitates lung-protective ventilation, allowing a patient's lungs to heal faster and reduce the length of stay in the ICU.
The companies are cooperating in late-stage development. First clinical applications are planned to commence by early-2013 and the product launch is aimed for second half of 2013. The therapy objective is achieved by removal of CO2 directly from the patient's blood. When the lung is failing and its function is significantly impaired, CO2 will be cleared from the blood by means of extracorporeal gas exchange devices, so-called membrane ventilators.
In addition, this therapy provides a tool to correct the blood's pH value independent from the patient's lung, to reliably realise lung protective ventilation in patients on invasive mechanical ventilation (<6mL/kg tidal volume administered) and to reduce ventilator related complications (VALI, VAP, VIDD) as well as the time the patient must be connected to a ventilator.
Gambro invented and developed the Prisma and Prismaflex systems to deliver highly advanced treatments for critically ill acute kidney injury patients requiring CRRT. The Prisma system, launched in Europe in 1995, and in the US in 1997, was the first automated, integrated system specifically designed to perform the complete range of CRRT modalities as well as therapeutic plasma exchange. The Prismaflex system, a next-generation system for CRRT, was introduced in Europe in 2004 and in the US in 2005.