1st patient implanted with Aria CV balloon system as PAH treatment

New Gen 2 system aims to restore normal function of pulmonary artery

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Aria CV’s second-generation medical device for treating people with pulmonary arterial hypertension (PAH) — a balloon system known as the Gen 2 — has been successfully implanted in the first patient taking part in a U.S. study, according to a company press release.

The Gen 2 system was designed to restore the normal function of the pulmonary artery, with an aim of reducing the workload on heart muscles and increasing blood flow in PAH patients.

In the trial, dubbed ASPIRE PH (NCT04555161), an estimated 30 patients will receive the Gen 2 system in a surgical procedure as a PAH treatment. The first surgery was completed this month at the Ascension St. Vincent Cardiovascular Research Institute, in Indianapolis. It was conducted by Ashwin Ravichandran, MD, and Scott Hittinger, MD.

“The successful patient implant of the Gen 2 system is a significant milestone in realizing our mission to improve the lives of those suffering from pulmonary hypertension, a life-threatening disease that can lead to heart failure,” said Dan Gladney, president and CEO of Aria CV.

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In PAH, increased blood pressure in the pulmonary arteries makes the right side of the heart work harder to pump blood to the lungs. With time, this excess workload can lead to right heart failure.

The Gen 2 system is based on a gas-filled balloon that’s surgically placed into the pulmonary artery to mimic its natural function. Specifically, it collapses and expands according to the motion of the heart, which, respectively, maximizes the amount of blood pumped per minute and makes room for the incoming blood. The device does not need a battery or any other electronic component to operate.

“We are proud to have performed the first implant of this novel device, as it offers an alternative treatment for patients who remain significantly impacted by right heart dysfunction related to pulmonary hypertension, which has limited approved therapy options,” Ravichandran said.

ASPIRE PH is testing the safety and efficacy of the Gen 2 system in patients with pulmonary hypertension and right heart dysfunction at U.S. medical centers across nine states. Enrollment is underway in all but two states, whose sites are not yet recruiting. Participants are evaluated before and at specific times after the surgery, with follow-up lasting two years.

If [ultimately] approved, this technology has the potential to be lifesaving and life changing for thousands of patients with pulmonary hypertension.

A Series B financing round, completed in 2020, helped fund the clinical trial, which is being conducted as part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study Program. This program aims to expedite the development of novel medical devices.

Aria CV’s system was designated a breakthrough device by the FDA in 2020. It had previously won the Transcatheter Cardiovascular Therapeutics 2018 Shark Tank Competition for its novelty and potential to bring change to the field of cardiovascular medicine.

Gladney noted that the Aria CV team is eager to see this device make its way to patients as a PAH treatment.

“This procedure is a testament to the dedicated ASPIRE PH team that is providing patients with a novel therapeutic option to treat this deadly condition. If approved, this technology has the potential to be lifesaving and life changing for thousands of patients with pulmonary hypertension,” Gladney said.

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