Treating Pulmonary Embolism: How Safe and Effective Are New Devices?

[2greys]

Pulmonary embolism (PE), a blood clot lodged in one of the pulmonary arteries in the lungs, is the third leading cause of cardiovascular-related death in the United States. While most patients are treated with anticoagulants (commonly known as blood thinners), the use of novel interventional devices that remove or dissolve clots in the lungs has significantly increased in recent years. Yet, there is little data—particularly, as it pertains to the treatment of patients with “intermediate-risk PE”—that suggests these approaches are more safe and effective than the use of anticoagulation alone, according to a new scientific statement from the American Heart Association (AHA) that was led by Penn Medicine.

newswise.com/articles/treat...

[Cateran]

I note that the Class 3 devices require premarket approval by the FDA. American governance of technological change isn't always as reliable as with interventional therapy in health care as it is generally within the US economy and finance capital. The class 2 devices in the Penn article refers to patient-specific risk factors and that some trials can go ahead with limited use of devices. My guess is that the free market ideology which determines much of technological production and health care in the US may well trump the usual precautionary regulations and oversight of the FDA about Class 3 devices, sooner or later.