Technology

Extracorporeal Shock Wave Therapy (ESWT)

If you’re at the start of your shockwave therapy research journey, a frequent acronym you’re bound to encounter is ESWT. It stands for Extracorporeal Shock Wave Therapy. It’s a general term that’s been around for decades and covers shockwave therapy use in multiple fields of medicine. The word extracorporeal, in scientific parlance, means outside the body. With ESWT the distinction is that the shockwaves are generated from outside the body and delivered inside the body in a non-invasive, non-surgical way. The first type of ESWT used in medicine was a procedure known as ESWL – Extracorporeal Shock Wave Lithotripsy. ESWL was a type of high-intensity shockwave therapy that used shockwaves to break kidney stones into fragments small enough to be passed naturally by the body. ESWL was groundbreaking technology that was once described as “one of the most peaceful use of shockwaves for the welfare of mankind.” ESWL is still in use today.

Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)

The success of ESWL inspired researchers to see if the power of shock waves could be leveraged for other applications in medicine. When researchers found the energy levels of shockwaves could be adjusted, shockwaves of different intensities were examined to see if they could be of therapeutic use. Medium-intensity shockwaves, for example, were applied to orthopedics and cardiology with high degrees of success. Medispec, which specialized in the design and manufacture of shockwave technology, investigated the use of low-intensity shockwaves to treat ED. This lead to the development of shockwave instrumentation specifically for Erectile Dysfunction – using just one-tenth of the shockwave power used in lithotripsy. Researchers called this new mode of therapy ‘Li-ESWT’ – short for Low Intensity Extracorporeal Shock Wave Therapy, with low intensity referring to a wave of lower intensity relative to the high-intensity wave that was required to disintegrate kidney stones with ESWL.

Randomized, Double-Blind and Placebo-Controlled (RDBPC) Studies

The ideal way to determine the effectiveness of a brand new mode of treatment like Li-ESWT, so that it is universally accepted by the scientific community, is through systematic studies. In other words, the new mode’s effectiveness has to be documented by solid research. Accordingly, Medispec, a company truly dedicated to high-quality scientific research, invested in the gold standard of study design – randomized, double-blind and placebo-controlled, known as RDBPC’s. Participants in the study were subjected to Li-ESWT using the new device engineered by Medispec – which would later be named the ED1000. The main outcomes measured in the study were pain, function, and adverse effects. Published in 2012, the study provided substantial evidence that without any adverse effects and with “no reported treatment-associated pain” Medispec’s Li-ESWT device generated “a genuine physiological effect on the erectile mechanism.” This was a big win for Medispec and as a result, Medispec brought to market, the world’s first Li-ESWT device – branded as the ED1000. The ED1000 was a bona fide technological leap forward – offering men with vascular Erectile Dysfunction, the completely new option of an entirely non-invasive, non-pharma treatment for the very first time.

Erectile Dysfunction Shock Wave Therapy (EDSWT)

The fact was, not only was Medispec introducing a new device into the global marketplace, it was also introducing an entirely new mode of treatment. Recall, Li-ESWT was the name for the new modality used in research and it highlighted the alteration of the wave used in lithotripsy to one of a lower intensity specifically for Erectile Dysfunction. While Li-ESWT was meaningful in research circles, it wasn’t to the lay public. So, Medispec coined an alternative acronym that emphasized the new treatment modality was specifically for Erectile Dysfunction. They called it EDSWT, which stood for Erectile Dysfunction Shock Wave Therapy. Today, both Li-ESWT and EDSWT, continue to be used as different names for the same modality.

Focused Shockwaves

Since shockwaves are generated outside of the body, it’s essential that they’re guided to the tissue that requires treatment. This is why focusing is important. To put it plainly – to get the desired biological effect, once the shockwaves are generated, you don’t want the energy to spread out in all directions, you want to focus it to one point. When the energy is focused on one point, in a way, it piles up on top of itself to a really high peak energy. The area around the peak where most of the energy is deposited is called the focal zone. The highest level of output energy delivered occurs in the focal zone. The size of that focal zone and the amount of energy in that focal zone also determines the effectiveness of treatment. Focusing shockwaves is a matter of the greatest practical importance. In order to focus the shockwaves in a very controlled way, Medispec developed a hand-held probe which focused the shockwave energy at a depth, diameter, and setting optimal for treating Erectile Dysfunction. Additionally, the unique, patented probe design produced the largest focal zones in the industry.

Advantages of the Electro-hydraulic Method of Wave Production

Focused shock waves can be generated by electro-hydraulic (EH), electro-magnetic (EM) or piezo-electric (PE) means. Each type of generator has its own advantages and disadvantages. When it comes to the treatment of Erectile Dysfunction however, the electro-hydraulic method is the shockwave generating method of choice as it offers some real advantages. For example, in terms of energy-setting capabilities, the electro-hydraulic system produces true shockwaves at all energy settings, whereas the electromagnetic and piezoelectric systems can produce true shockwaves only at high-energy settings. With the ED1000 device, shockwaves are powered by electro-hydraulic means, which allows for a low-intensity setting. In fact, Medispec’s EDSWT device is precisely calibrated to deliver low-intensity shockwaves of just 0.09 mJ/mm2. A benefit of the low-intensity shockwaves produced with ED1000, as compared with other treatment options using high energy, is that no topical anesthetic gels are necessary. ED1000 Therapy is a delicate process that does not induce pain and in most cases little or no discomfort is reported.

Focal Zone

Returning to the term focal zone. We know this: shockwaves generated with different types of generators deliver differently-sized focal zones. When it comes to treating ED, larger focal zones are preferable. One of the benefits of electro-hydraulic shockwave generating systems is that they deliver the largest focal zones. Notably, Medispec’s proprietary technology used in ED1000 Therapy produces the largest focal zones in the industry. Larger focal zones mean that a greater amount of shockwave energy can be delivered over a shorter period of time to the targeted tissue. In other words, larger focal zones allow for not only deeper, but also broader tissue penetration at each shock site. These parameters permit a reduction of treatment times, since fewer total impulses are required compared with other technologies on the market. It should be mentioned that ED1000 Therapy is standardized to a fixed set of 5 treatment sites, as compared to other available devices whose protocols dictate the need for many more treatment sites. Moreover, in addition to fixed treatment sites, the ED1000 device is pre-programmed to control delivery of therapy based on pre-set parameters of intensity, time and number of shocks.

ED1000 – Now in the USA

Approved for use in Canada in 2012, Medispec’s ED1000 Therapy has recently received regulatory approval from the US Food and Drug Administration as a treatment method for Erectile Dysfunction. Today, ED1000 Therapy continues to make life better for more and more men around the world in 32 countries and continues to remain unmatched in clinical research supporting its benefits and validating its efficacy.

Erectile dysfunction treatment technology: ED1000