The gospel of patients with PAD! FDA approves Shockwave Medical's new sonic airbags to be marketed

Release date: 2016-09-21

Cardiovascular disease has always been one of the biggest threats to human health. Due to people's living and eating habits, many patients have a narrowing of the arterial lumen and a slowing of blood flow, resulting in a series of disease symptoms. In recent years, angioplasty-based airbag devices have flourished in this disease field. Recently, the FDA approved the launch of Shockwave Medical's latest angioplasty balloon device, Lithoplasty, for the treatment of patients with cardiovascular disease with vascular calcification. This is also the first medical device on the market that can treat vascular calcification.

According to the American College of Cardiology, peripheral arterial disease (PAD) has a wide range of influences, with more than 9 million people in the United States alone. As the arterial lumen narrows and the blood flow slows down, the blood reaches the patient's limbs at a slower rate, causing a series of adverse symptoms. Arterial calcification is very common in PAD patient populations. Despite the popularity of angioplasty, the pain of PAD patients has been greatly alleviated, but the treatment for vascular calcification is a blank.

The Lithoplasty device developed by Shockwave Medical combines traditional balloon angioplasty with ultrasonic lithotripsy to solve this problem. Ultrasonic lithotripsy is often used to treat kidney stones, and clinicians use ultrasound to break the kidney stones in the patient's kidneys. With the ultrasound device on the device, the doctor will be able to remove the calcification on the surface and deep layers of the patient's blood vessels, softening the blood vessels while expanding the arterial lumen. The researchers said that this method can effectively reduce the damage of blood vessels caused by traditional therapies.

The FDA's decision is based on the results of the company's current two-stage, single-blind, multicenter clinical study. These two clinical studies have shown that the device performs well in all patient subpopulations, immediately improving the patient's blood flow velocity and minimizing patient vascular damage.

Currently, Shockwave plans to list the product in the US market next year, and the company will continue to conduct a global clinical study to further collect data related to Lithoplasty.

Source: Bio Valley

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