Extracorporeal Shock Wave Treatment

Sanuwave

An Overview

The benefits of extracorporeal shock wave treatment (ESWT) are broad and profound. ESWT can be effectively used in conjunction with other therapies to address acute and chronic soft tissue wounds. ESWT seems to work along many different pathways to facilitate healthy and complete healing. Among the benefits of ESWT are:

  • an increase in blood flow perfusion
  • epithelialization (reepithelialization) – covering the injury with new skin and mucous membranes
  • facilitation of wound closure
  • improved angiogenesis – formation of new blood vessels and capillaries
  • improved tissue granulation – the filling of the wounds
  • reduced necrotic fibrin tissue – dead tissue
  • reduction in duration of healing
  • reduction in the need for antibiotic use

Orthopedics Treatment

Musculoskeletal injuries are among the most common reasons for visiting a physician in the United States. More than 25% of Americans suffer from one kind of musculoskeletal impairment or another. This accounts for over 130 million doctor’s visits and $850 billion yearly. There is research currently underway examining the effectiveness of ESWT on these types of injuries. If successful, shock wave therapy could be added to the arsenal of effective, non-invasive treatments at physican’s disposal. 

Non-Union Fractures

The United States medical field treats millions of broken bones a year. Of these, over one million require surgery. In order to prevent the fractures from healing improperly, the bone is physically rejoined. During the internal fixation procedure, as it is known, the surgeon will use special screws, plates, rods, wires, or nails to hold the bones in the correct place. The majority of all traumatic long bone fractures undergo surgery and internal fixation. With that said, fractures resulting from car accidents or other high-impact traumatic injuries remain at risk for poor healing. Between 10 to 30 percent of such fractures are at risk improper healing, including those that don’t correctly mend. Non-union joints lead to increased risks and complications.

Osteoporosis and Osteoarthritis 

There are currently over 135 million people diagnosed with arthritis all over the world. This includes close to 33 million people over the age of 18 with osteoarthritis in the United States. The number of people suffering from osteoarthritis in the U.S. is expected to more than double in the next 10 years. One of the defining factors of osteoarthritis is the mechanical disintegration of cartilage and joint surfaces. Advanced cases of arthritis warrant surgery and joint replacement in up to 30 percent of patients. According to The American Joint Replacement Registry (AJRR) there are over one million joint replacements per year in the U.S. costing over $15 billion annually This number is expected to grow by 85% by the year 2030.

I have a Special Health Condition. Is ESWT Right for Me?

Some pre-existing medical conditions could possibly complicate ESWT procedures. More research is needed to determine the effectiveness and safety of using ESWT with different underlying health concerns. Your healthcare provider will complete a full medical history and exam before proceeding with ESWT. A discussion about the pertinent information regarding how these and other health conditions might affect the outcome of an ESWT procedure will likely follow.

The following is a list of treatments and pre-existing medical conditions that may raise red flags for your provider: 

  • a cuff rupture when treating the shoulder,
  • anatomical anomalies in the treatment area,
  • malignancies found in the treatment area,
  • patients with coagulation disorders and
  • the presence of inflammation in the treatment area

Additionally, treatment in the following areas has not yet been proven to be safe:

  • in the area of the gonads
  • in the lung area,
  • on the spinal column and
  • the head area.

There has been little to no research on ESWT in treating:

  • children,
  • individuals with implants in the treatment area,
  • patients with pacemakers or
  • pregnant women

Product Overview

The dermaPACE System is cleared by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers. It is also CE Marked and for sale in select international markets.

The orthoPACE System is CE Marked for international markets for orthopedic and musculoskeletal indications, but it is NOT CLEARED FOR USE in the United States by the U.S. Food and Drug Administration (FDA).

What About Safety?

Medical innovators originally designed Shockwave treatment to treat kidney stones back in the 1990’s. Over the interceding three decades, researchers and practitioners have collected a wealth of data and medical experience in the realm of Shockwave therapies. These practical lessons have been combined with advancements in engineering to produce a medical tool like none other on the market. The state-of-the-art dermaPACE device represents the gold standard in Shockwave technologies. Optimizing quality, efficacy and safety were at the heart of the development process. The dermaPACE has undergone comprehensive clinical studies and rigorous testing to confirm its safety and efficiency.

Is it Safe for Everyone?

Medical professionals all over the world have come to believe that DermaPACE can facilitate proper and speedy healing in the vast majority of patients. It is, however, yet to be approved for use on patients with some special medical conditions. You should talk to your healthcare provider before undergoing DermaPACE therapy if you have any of the following medical conditions: 

  • coagulation disorders and
  • malignancies in the treatment area.

PACE treatments have not been approved to be used on the following areas:

  • the gonads,
  • the area of the head,
  • around the lungs and
  • on the spinal column

There has had almost no experience in treating:

  • children,
  • individuals with implants in the treatment area,
  • people with pacemakers or
  • pregnant women.

Research conducted using Doppler imaging to measure blood flow in treatment areas have demonstrated a marked increase in blood perfusion and vessel density after 24 hours from treatment. This finding is valuable because it decreases the chances of ischemia (lack of blood flow) that is so often associated with inadequate healing. It is important to note that studies have shown that patients who have undergone PACE intervention did not experience any negative vascular side effects such as an unsafe change in blood pressure.