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.
- Evaluate for accuracy and reproducibility of data collected via the participant-operated
Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician
- Determine whether the WTT app on the Apple Watch can accurately collect information
on distance traveled and heart rate (HR) during in-clinic 6MWT run by American
Thoracic Society (ATS) guidelines
- Determine whether participants can operate the WTT app and Apple Watch effectively
to gather accurate data in a monitored and home-based setting
- Prospectively monitor for...
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