Dornier Medical Systems Formation (1986 – 1987):
– Dornier Medical Systems was formed in the U.S. and owned by Daimler Benz.
– They invented the kidney lithotripter, a $2 million machine for non-surgical kidney stone treatment.
Discovery of Shockwave Technology:
– It originated from aeronautical engineering.
– Engineers observed shockwaves damaging aircraft wings during supersonic flight.
– They realized shockwaves could be used in medical science to treat kidney stones.
Introduction and Adoption in the U.S.:
– Shockwave technology was brought to the U.S. in 1987.
– The initial employee team comprised mostly older professionals.
Mechanism and Evolution of Shockwave Therapy:
– Electrohydraulic shockwaves use focused high energy to break up kidney stones.
– Initially, the focus was on causing trauma to treat conditions.
FDA and Early Medical Studies:
– Studies were conducted to understand the effects of shockwaves on bones.
– They discovered that shockwaves did not harm bones but thickened them, indicating potential beyond kidney stones.
Expansion of Applications:
– Dr. Wolfgang Schoden commercialized shockwaves for non-healing fractures and orthopedic applications.
– He noted that pain relief occurred before healing, suggesting broader sports applications.
– The first non-kidney stone FDA approval in the U.S. was for plantar fasciitis.
Insurance and Market Challenges:
– Insurance companies resisted coverage due to high costs.
– Initially, shockwave therapy required general anesthesia, making it expensive and less accessible.
Unfocused Shockwave Discovery:
– In Vienna, Dr. Schoden discovered that lower energy unfocused shockwaves were effective.
– Unfocused waves promoted healing without causing trauma- He observed healing in non
-targeted areas, suggesting stem cell activation.
Formation of TRT and Subsequent FDA Challenges:
– TRT was formed with a $10 million budget.
– It faced unexpected FDA reclassification to class three, complicating approval.
– The first FDA clearance was gained in 2018 through political intervention, focusing on connective tissue activation.
Current Status and Future Plans:
– Multiple FDA clearances have been obtained for various conditions.
– Ongoing efforts are being made to expand approved applications for shockwave therapy.
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