TReatment Of Pulmonary HYpertension 1-US Study

Inclusion Criteria:

- Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH,
connective tissue disease PAH, Anorexogen induced or Heritable PAH

- PAH diagnosis confirmed by hemodynamic evaluation performed prior to screening and
showing all of the following: Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest;
Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure
(LVEDP) ≤15 mmHg; Pulmonary vascular resistance (PVR) at rest >3 Wood units; Not
meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤
40 mmHg).

- Patient with a current diagnosis of WHO functional class III

- Patient taking two pulmonary arterial hypertension specific medications other than
parenteral prostanoids

- Patient is adhering to a stable drug regimen (i.e., with no changes of dose or
medication for a minimum of 3 months prior to enrollment)

- Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂
150µmol/l

Exclusion Criteria:

- Patients who are treated with parenteral prostanoids

- Pregnant women or women planning a pregnancy within 12 months of study enrolment

- Patient with significant co-morbid condition(s) which, at the discretion of the PI,
are deemed to prohibit study entry

- Patient with life expectancy of less than a year

- Concurrent enrollment in another device or drug trial except for observational studies
(unless specifically approved by the sponsor)

- Patient with pulmonary artery anatomy that precludes treatment

- Patient with moderate to severe pulmonary artery stenosis

- Patient with any pulmonary artery aneurysm

- Patient who has experienced a myocardial infarction, unstable angina pectoris, or a
cerebrovascular accident in the previous 6 months

- Patient who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug
infusion devices

- Patients who are unable to undergo an MRI scan