The investigators are testing whether the addition of Pulmonary Hypertension-related
biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation
for Pulmonary Hypertension will lead to more informed choices of Pulmonary Hypertension
therapy and improved patient outcomes.
The objective of this study is to assess the safety, performance and initial effectiveness of
the TIVUS™ System when used for pulmonary artery denervation through subjective and objective
change in clinical parameters and haemodynamic evaluation. This is a prospective,
multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to
4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who
have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific
The objective of this study is to assess the safety and initial effectiveness of the TIVUS™
System when used for pulmonary artery denervation in group II PH patients through change in
clinical parameters including hemodynamics, exercise tolerance, and quality of life.
This is a prospective, multi-center, non-randomized, open-label clinical trail. The study
will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with
pulmonary hypertension due to left heart disease that demonstrate combined pre and post
capillary involvement with PVR>3 wood units.
An expanded access program that provides INOpulse treatment to patients with serious disease
or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who
are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.
Progressive SSc is an entity with limited therapeutic alternatives and with asurvival rate of
less than 45% in the first 3 to 5 years. The disease causessevere limitation in quality of
life ranging from functional limitation to depression. Up to 20% of patients will be
refractory to conventional treatment with diseasemodifying anti-rheumatic drugs (DMARDs) and
cyclophosphamide therapy.This favors the progression to visceral involvement including
gastrointestinal,lung and pulmonary hypertension. The latter being a poor prognostic
factor,increases mortality in this group of patients and drastically affects their qualityof
This is an Expanded Access Program (EAP) for eligible participants with Pulmonary
Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to
Inhaled Treprostinil. Availability will depend on territory elegibility.