Aria CV has kicked off its ASPIRE PH trial and successfully implanted the first patient with its system to treat pulmonary hypertension.
The patient was implanted with Aria CV’s Gen 2 pulmonary hypertension system – a gas-filled balloon administered percutaneously.
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Pulmonary hypertension is characterised by high blood pressure in lung arteries, which causes the heart to work harder to counteract the pressure, which can lead to right heart failure.
Aria CV’s device, which was granted US Food and Drug Administration breakthrough designation in 2020, aims to reduce cardiac workload. It is implanted in the main pulmonary artery and designed to restore the vessel’s healthy status, thereby mitigating right heart failure. According to the company, the device is driven by the heart and has no battery, pump or electronics.
The ASPIRE PH trial (NCT04555161) is an early feasibility study assessing the safety and performance of Aria CV’s system. The trial aims to enrol 30 participants with pulmonary hypertension, according to a ClinicalTrials.gov entry. The primary endpoint is the incidence of serious adverse events related to the device or the procedure through 30 days.
Dr Ashwin Ravichandran, who helped perform the first procedure, said: “[This device] offers an alternative treatment for patients who remain significantly impacted by right heart dysfunction related to pulmonary hypertension, which has limited approved therapy options.”
Pulmonary hypertension, which has around 500–1,000 new cases in the US each year, is a relatively untapped therapy space in medtech. Currently, the disease is managed by a plethora of pharmaceutical products including endothelin receptor antagonists, phosphodiesterase-5 inhibitors and prostacyclins.
The study is being funded by a Series B financing round from 2020, in which the company raised $31m.
Also in the space is Gradient Denervation Technologies, which is currently conducting a clinical study for an implanted device. The Paris-based company completed the first-in-human procedure in June 2023.
The global cardiovascular device market was estimated to be worth nearly $60bn in 2023. It is forecast to grow to more than $86bn by 2030, according to a report by GlobalData.
