Worried about iNO safety in your NICU?

Now you can all breathe easier — the ULSPIRA TS™ is specifically designed to simplify iNO treatment and increase patient safety

An integral part of the ULSPIRA Solution™ is the ULSPIRA TS, our nitric oxide therapy system designed for ease of use and patient safety in mind, providing simplified treatment management to bring inhaled NO therapy to the next level. Our therapy system is supported by our team of clinical applications specialists who are trained RTs with years of nitric oxide therapy experience.

Now you can take advantage of special pricing and terms pre-negotiated by Premier for all your iNO therapy needs. Complete the form for more information.

Learn more about the ULSPIRA Solution today

ULSPIRA Indication and Important Safety Information

ULSPIRA (nitric oxide) gas, for inhalation, is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Contraindications

ULSPIRA is contraindicated in neonates dependent on right-to-left shunting of blood.

Warnings and Precautions

• Rebound: Abrupt discontinuation of ULSPIRA may lead to worsening oxygenation and increasing pulmonary artery pressure.
• Methemoglogin: Methemoglobin increases with the dose of ULSPIRA and is dose dependent. Following discontinuation or reduction of nitric oxide, methemoglobin levels can take up to 8 hours or more to return to baseline. If methemoglobin levels do not resolve with decrease in dose or discontinuation of ULSPIRA, additional therapy may be warranted to treat methemoglobinemia.
• Elevated Levels: Monitor for PaO₂, inspired nitrogen dioxide (NO₂), and methemoglobin during ULSPIRA administration.
• Heart Failure: In patients with pre-existing left ventricular dysfunction, ULSPIRA may increase pulmonary capillary wedge pressure, leading to pulmonary edema.
• Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

Adverse Reactions

The most common adverse reaction of ULSPIRA is hypotension.

Drug Interactions

Nitric Oxide donor compounds may increase the risk of developing methemoglobinemia.

Use With Delivery System

ULSPIRA must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System operated by trained personnel. Only validated ventilator systems should be used in conjunction with ULSPIRA.

Adverse Events

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full ULSPIRA prescribing information for additional ULSPIRA safety and risk information.

ULSPIRA TS Safety Statement

Intended Use

The ULSPIRA TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO₂ and O₂ concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.

ULSPIRA TS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling, and is indicated for use in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.

In the case of an abrupt stop of inhaled NO gas delivery, withdrawal (rebound pulmonary hypertension) may occur. Possible side-effects of the inhaled NO gas therapy are further described in the nitric oxide drug packaging inserts and labeling.

ULSPIRA TS can be used with respiratory devices. Make sure that ULSPIRA TS is validated with the respiratory device you use. Validated respiratory devices are listed in the User's Manual.

Device Warnings:

• Persons using ULSPIRA TS must be trained and experienced in its use to ensure effective administration of nitric oxide and to avoid injury to the patient or to others resulting from inhalation of excess NO, NO₂ or other reaction products.
• Always perform a Pre-Use Check before connecting ULSPIRA TS to the patient. Only use the system if the Pre-Use Check is successfully passed.
• If an unintended treatment interruption occurs, use the backup system.
• ULSPIRA TS must not be used in an MRI environment.

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