FDA approves third generation tankless Genosyl for neonatal intensive care

The US Food and Drug Administration (FDA) has approved the third generation of the tankless Genosyl (nitric oxide; VERO Biotech Inc) system for neonatal intensive care.

Genosyl has 3 new features to provide benefits for patients and providers. The first is faster dosing, using an adaptive sensor and automated cassette action to reach the needed dose sooner. 

The second feature is a simpler workflow, with a dual cassette bay allowing physicians to work from a single console, rather than having to switch to a second. The third feature is operational efficiency, with an improved user interface and disposable cassettes that are lighter and smaller, reducing storage constraints.

Genosyl is a tankless inhaled nitric oxide (iNO) delivery system, delivering iNO at patients’ bedsides. This simplifies workflow by removing the management of large tanks.

The iNO is used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension through the dilation of pulmonary blood vessels. This reduces the need for extracorporeal membrane oxygenation in neonates with a gestational age over 34 weeks.

Genosyl treatment requires right-to-left shunting of blood. Sudden discontinuation can cause worsening oxygenation and rising pulmonary artery pressure. Nitric oxide dosage raises methemoglobin levels, which will return to baseline hours after discontinuation. Clinicians should monitor methemoglobin, NO2, and PaO2 levels throughout administration.

There is a risk of increased pulmonary capillary wedge pressure from Genosyl in patients with pre-existing left ventricular dysfunction. This can cause pulmonary edema.

Hypotension is the most common adverse event seen in patients taking Genosyl. Alongside Genosyl, nitric oxide donor compounds can have an addictive effect which increases the risk of methemoglobinemia.

A calibrated Genosyl Delivery System should be used for administration, with only validated ventilator systems or nasal cannulas used in conjunction with Genosyl.

Reference

VERO Biotech receives FDA approval of its third generation tankless inhaled nitric oxide delivery system. VERO Biotech LLC. January 9, 2023. Accessed January 9, 2023. https://www.prnewswire.com/news-releases/vero-biotech-receives-fda-approval-of-its-third-generation-tankless-inhaled-nitric-oxide-delivery-system-301716118.html