According to a story from Benzinga, the medical device company V-Wave Ltd. has recently announced that a product in development by the company has earned Breakthrough Device designation from the US Food and Drug Administration (FDA) for the second time. The device in question is the interatrial shunt. The agency awarded this designation for the treatment of pulmonary arterial hypertension, a rare lung condition. The interatrial shunt had first earned Breakthrough Device designation for heart failure.
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.
About Breakthrough Device Designation
Breakthrough Device designation is a program from the FDA that can allow promising medical devices to get approved more quickly. This designation is similar to Priority Review in that a device under this designation can earn market approval more rapidly using surrogate or intermediate endpoints that are determined to correspond with meaningful patient improvement. More traditional clinical data would be gathered after the device has entered the market. A device that fulfills an unmet medical need or offers advantages over currently available devices has the potential to earn Breakthrough Device designation.