Medical Device to Treat Erectile Dysfunction, Clinical Approval

A clinical trial for medical devices that treat erectile dysfunction by physically stimulating male penis has been approved in the US. It is the first time since October 2003 that the KFDA published the clinical details on its homepage to verify the efficacy of treating erectile dysfunction using medical devices.

According to the Ministry of Food and Drug Safety and the medical community on March 25, the Catholic. Mary’s Hospital was approved by the Ministry of Food and Drug Safety for clinical trials to treat erectile dysfunction with an extracorporeal shock wave therapy device developed by US medical device company Euro & Tech.

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This clinical trial is to find out whether it is effective in treating erectile dysfunction after giving a shock to the penis with an extracorporeal shock wave therapy device. Euro & Tech’s shock wave therapy device is already on the market, and this clinical trial can be seen as a step to determine whether erectile dysfunction can expand the indication (a disease that is expected to be effective).

A hospital official said, “The trial is being reviewed by the Hospital Institutional Review Board (IRB).” IRB is a pre-clinical step that consists of clinical staff members and external personnel to check whether the protocol is properly organized and review moral and ethical issues.

An official from the US Food and Drug Administration explained, “The clinical trial at Seoul St. Mary’s Hospital is not a clinical trial that leads to the expansion of indications, but it can be seen as the nature of exploring the possibility of treating erectile dysfunction of domestic in vitro shock wave therapy device.” In fact, if the results of this research-led clinical trial show good results, it is highly likely that a company-led confirmatory clinical trial aimed at expanding the indications of in vitro septal therapy devices will likely proceed.

The treatment of true libido erectile dysfunction using an in vitro shock wave therapy machine has already been published in various studies. Researchers from the University of California, San Francisco, in July, published a study in the European Journal of European Urology, which showed an average improvement in erectile function in mild patients treated with extracorporeal shockwave therapy in July.

The University of California’s research team anticipates that in vitro shockwave therapy will be a new alternative for patients who have difficulty or cannot work with erectile dysfunction.

It is also concerned that this clinical trial will lead to the launch of a new domestic medical device to replace the erectile dysfunction treatment. Overseas companies have already succeeded in the commercialization of the treatment device to dominate the domestic erectile dysfunction treatment market, but domestic companies are not able to come up with suitable products.

Introduced in 2013, the ‘in vitro shock wave erectile dysfunction treatment device (ED-1000)’ was developed by the Israeli company Medispec. Using the treatment device, the penis is shocked, causing small wounds on the blood vessels, and a substance called vascular endothelial growth factor (VEFG) comes out to create new blood vessels and regenerate muscle and nerve tissue. It is similar to the dermatological treatment of dermatology, which injures the skin and induces new growth.

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Because it is a kind of physical therapy, even if you are taking medicine, you do not have to stop treatment or worry about complications.

how to cure erectile dysfunction naturally and permanently treatment market using medical devices is highly valued for growth. The US Extracorporeal Shock Wave Society, founded by doctors in May, plans to expand the treatment area and create treatment guidelines by using extracorporeal shock waves. In the future, if there are guidelines for treatment at the society level, patients with erectile dysfunction using extracorporeal shock waves are expected to increase.

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