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Novel system for PAH receives FDA breakthrough device designation
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The FDA has granted breakthrough device designation to a therapeutic intravascular ultrasound system for patients with pulmonary artery hypertension, according to a manufacturer press release.
The device (TIVUS, SoniVie) is a therapeutic ultrasound catheter that is inserted into the pulmonary artery during a right heart catheterization procedure and is designed to ablate nerves associated with disease activity without damaging the vessel walls or the adjacent tissues to improve quality of life and clinical outcomes.
The FDA’s decision follows presentation of data from the TROPHY1 trial at EuroPCR in May. The trial enrolled 23 patients with PAH who were WHO functional class III and were on an established regimen of dual-oral medical therapy. In the trial, treatment with the device was associated with improvements in pulmonary vascular resistance, mean pulmonary artery pressure, 6-minute walk distance, daily activity and European Society of Cardiology low-risk indicators compared with baseline assessments. There were also no serious adverse events related to the procedure or the device, according to the release.
“PAH is classified as a life-threatening or irreversibly debilitating disease because it is characterized by a progress increase in pulmonary vascular resistance that leads to right-sided heart failure and death,” Lewis Rubin, MD, emeritus professor of medicine at the University of California, San Diego, School of Medicine and adjunct professor of medicine at the Columbia University College of Physicians and Surgeons, said in the release. “There are no approved medical device treatment options for PAH, only medications. The TIVUS system has been shown in early clinical studies to stabilize or improve pulmonary vascular resistance in PAH patients, suggesting that it could offer significant incremental benefits to a patient population that has a 5-year mortality greater than 40%.”
Disclosure: Healio Pulmonology could not confirm relevant financial disclosures at the time of publication.