US FDA approves first cardiovascular disease sonication technology

Recently, the US FDA approved the Lithoplasty system for the treatment of vascular calcification plaques in patients with peripheral arterial disease (PAD), which was developed by Shockwave Medical, one of the pioneers dedicated to the treatment of calcified cardiovascular disease. It is expected to integrate Lithoplasty into the nursing pathway and improve it. The condition of patients with advanced cardiovascular disease.

Peripheral arterial disease is a vascular disease in the peripheral region of the heart, also known as peripheral vascular disease. Symptoms of the disease are mainly characterized by limited blood flow reaching the body parts such as the legs and feet, causing severe pain and limited mobility in the limbs. In the most severe cases, surgery or even amputation may be required. The treatment of peripheral arterial disease depends on the severity of the disease, such as the doctor to develop a drug treatment plan according to the degree of disease deterioration, change the patient's lifestyle, or take a variety of programs such as angioplasty and stent implantation to open the blocked blood vessels. However, more than half of patients with this disease have moderate or severe calcification in their arteries, and it is often only possible to use the type of interventional device to successfully treat calcified arterial occlusion.

It is understood that the Lithoplasty system is the first medical device to selectively target arterial calcification plaques in patients with cardiovascular disease. The device integrates two mature and powerful science technologies: the calcium interference power of sound waves (commonly known as "gravel", which is commonly used to treat patients with kidney stones) and a simple angioplasty balloon catheter device. Intermittent pulsed lithotripsy can loosen superficial and deep vascular calcium deposits while minimizing soft tissue damage, and then integrated balloon angioplasty can expand and block the blood flow at low pressure to restore blood flow.

US FDA approves first cardiovascular disease sonication technology

Lithoplasty system

The US FDA's approval of the Lithoplasty system is based on a one-arm, two-stage, multi-center clinical study called DISRUPT PAD. The data show that DISRUPT PAD is consistently successful in all patient subgroups, and the marked increase rapidly Treats blood flow to blood vessels, causing minimal vascular damage.

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