FDA Grants IDE to Test Experimental Device for Pulmonary Arterial Hypertension

According to a story from GlobeNewswire, the medical device company SoniVie announced recently that the US Food and Drug Administration (FDA) has granted approval for its Investigational Device Exemption (IDE). This approval will allow the company to evaluate its proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS) as a therapy for patients living with pulmonary arterial hypertension, a rare disease that impacts the lungs.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplant. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.


TIVUS is classified as a dedicated therapeutic catheter. Using a right heart catheterization operation, the catheter is placed in the pulmonary artery. TIVUS is designed to ablate certain nerves that have been linked to activity in the disease while avoiding potential damage to nearby tissues or the blood vessel walls. TIVUS has earned the FDA’s Breakthrough Device designation, and previous studies of the device have demonstrated its effectiveness.

A new international trial will soon be under way and is expected to include a total of 168 patients. The main endpoint in this study will be improvements in the six-minute walk distance after a six month period. 

With an average survival time of only around five years, there is a clear need for more effective treatments for patients living with pulmonary arterial hypertension. TIVUS has the potential to provide considerable benefit without the side effects of pharmacological therapies.

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