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Think a new tankless iNO system includes expert clinical help?
Think Again!

The ULSPIRA Solution™ comes with all the support you and your staff need

Our iNO therapy device includes training and guidance from highly experienced and licensed RTs

Worried you’re on your own with a new iNO system?

Think Again — Our Clinical Services team of licensed RTs with years of NICU experience will make sure your staff is fully trained and provide on-going training as needed.

Afraid you won’t have any reference materials?

Think Again — Your ULSPIRA Solution includes a Welcome Kit with in-depth support materials to help you manage every step of setting up your device and delivering iNO therapy.

Concerned you’ll need more training after launch?

Think Again — Your ULSPIRA team offers clinical applications training and super-user training so that you can help your staff of RTs, plus full training for new staff when required.

Anxious about something going wrong and who can help?

Think Again — With the ULSPIRA Solution, you can all breathe easier, because we provide a professionally staffed 24/7 hotline to answer your questions and troubleshoot any issues.

Doubtful you may not have all the iNO expertise you need?

Think Again — Our Clinical Services team has years of iNO experience and a network of international iNO users and experts for collaboration and knowledge‑sharing.

Now there’s a total solution for iNO therapy in the NICU

It’s Time to Think Again. It’s Time to Learn More.

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Inspire breath into life with a human‑centered solution
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Specialist expertise with complete customer support
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The iNO therapy device for more safety and supply
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Customizable services to reduce your workload

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.

Rx Only

ULSPIRA Indication and Important Safety Information

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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.

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