HAMPTON, N.J., Nov. 13,
2012 /PRNewswire/ -- Ikaria, Inc., a critical care company
focused on developing and commercializing innovative therapies for
critically ill patients, today announced that the Center for
Devices and Radiological Health (CDRH) branch of the
U.S. Food and Drug Administration (FDA) has granted 510(k)
clearance for a software upgrade to enable connectivity of the
INOMAX® DSIR drug delivery system with hospital health
information systems.
This connectivity allows data regarding INOMAX® usage
to be transmitted directly to electronic medical records where it
can easily be viewed at computer stations to reduce charting time,
avoid transcription errors, and improve billing efficiency.
This feature, which is aligned with the effort by major health
systems to automate and capture patient data, also facilitates
reimbursement for INOMAX usage.
Additionally, the FDA has cleared three new, non-invasive
respiratory care devices for use with the INOMAX® DS and
DSIR drug-delivery systems -- the Fisher & Paykel Healthcare
Infant Circuit Nasal Cannula and Optiflow™ Breathing Circuit and
the A-Plus Medical Babi Plus™ Bubble CPAP. Sixty ventilators,
anesthesia systems and other respiratory care devices have now been
validated for use with Ikaria's INOMAX DS and DSIR drug-delivery
systems. This represents almost all FDA-cleared ventilation
strategies used in neonatal intensive care units (NICUs) throughout
the United States.
The INOMAX DS and INOMAX DSIR are proprietary drug-delivery
systems that deliver INOMAX® (nitric oxide) for
inhalation, the only drug approved by the FDA to treat hypoxic
respiratory failure (HRF) associated with pulmonary hypertension in
term and near-term infants greater than 34 weeks gestational
age. HRF is a serious condition in which blood vessels in the
lungs constrict, making it difficult to oxygenate blood.
INOMAX selectively relaxes pulmonary blood vessels, improves
oxygenation and treats HRF in this fragile newborn population.
These FDA clearances represent Ikaria's ongoing commitment to
meet the needs of its customers by offering features that assist
them in patient care, data reporting, and billing and
reimbursement, and to provide clinicians with the flexibility to
safely deliver INOMAX to critically ill patients using almost any
FDA-cleared ventilation strategy.
The INOMAX DS and INOMAX DSIR drug-delivery systems are part of
a comprehensive offering that, in addition to use of Ikaria's
proprietary, FDA-cleared drug-delivery systems, includes INOMAX
(nitric oxide) for inhalation, distribution, emergency delivery,
technical and clinical assistance, quality maintenance, on-site
hospital training, 24/7/365 customer service, and all related
disposable items.
A complete list of ventilators, anesthesia systems and other
respiratory care devices with which INOMAX drug-delivery systems
are validated, as well as additional information about INOMAX, can
be found at www.inomax.com.
About
INOMAX®
INOMAX®
is a vasodilator, which, in conjunction with ventilator support and
other appropriate agents, is indicated for the treatment of term
and near-term (>34 weeks gestation) neonates with hypoxic
respiratory failure associated with clinical or echocardiographic
evidence of pulmonary hypertension, where it improves oxygenation
and reduces the need for extracorporeal membrane oxygenation.
INOMAX should not be used in the treatment of neonates known to
be dependent on right-to-left shunting of blood. Abrupt
discontinuation of INOMAX may lead to a worsening condition.
Methemoglobinemia is a dose-dependent side effect of inhaled nitric
oxide therapy. Nitrogen dioxide (NO2) forms rapidly in
gas mixtures containing nitric oxide and oxygen, and therefore may
cause airway inflammation and damage. Methemoglobin,
NO2, and FiO2 should be monitored during
nitric oxide administration.
About Ikaria, Inc.
Ikaria, Inc. is a critical care
company focused on developing and commercializing innovative
therapies designed to address the significant needs of critically
ill patients. The company's lead product is INOMAX®
(nitric oxide) for inhalation, the only FDA-approved drug for the
treatment of hypoxic respiratory failure associated with pulmonary
hypertension in term and near-term infants. It is offered through
an all-inclusive offering of drug product, drug-delivery system,
on-site training and 24/7/365 technical assistance and support. The
INOMAX therapy package also is marketed in Puerto Rico, Canada, Australia, Mexico and Japan. The company is investigating additional
indications for INOMAX in bronchopulmonary dysplasia, and for
inhaled nitric oxide with the INOpulse® DS drug-delivery
system as a drug-device combination product in pulmonary arterial
hypertension (PAH) and pulmonary hypertension secondary to chronic
obstructive pulmonary disease (COPD). Ikaria's late-stage pipeline
is also comprised of terlipressin, a potential treatment for
Hepatorenal Syndrome Type 1 that is approved in Australia as LUCASSIN®, as well as
Bioabsorbable Cardiac Matrix (BCM), a potential treatment for
preventing cardiac remodeling and subsequent congestive heart
failure following acute myocardial infarction. Ikaria is
headquartered in Hampton, NJ, with
research facilities in North Brunswick,
NJ and Madison, WI and
manufacturing facilities in Port Allen,
LA and Madison, WI.
Please visit www.ikaria.com.
Company
Contact:
|
Media
Contact:
|
Samina
Bari
|
Tiberend
Strategic Advisors, Inc.
|
Ikaria,
Inc.
|
(212)
827-0020
|
(908)
238-6372
|
Claire
Sojda
|
samina.bari@ikaria.com
|
csojda@tiberend.com
|
SOURCE Ikaria, Inc.