ALPHARETTA, Ga., June 27,
2024 /PRNewswire/ -- Cardiac shockwave therapy leads
to the regeneration of heart tissue after coronary bypass surgery,
a study published in the prominent European Heart
Journal showed. The study is co-authored by SoftWave TRT
Medical Director Dr. Wolfgang
Schaden, one of the original founders of the shockwave
industry and pioneer of the regenerative applications of
shockwaves.
"I would not have expected that I could get old enough to really
see this happen, because there were so many obstacles over the
years," Dr. Schaden told BBC News in a medical report about
the study. "Johannes (Holfeld), in
my eyes, he's a hero."
The study led by Dr. Johannes
Holfeld from the Medical University of Innsbruck in
Austria performed an interim
analysis after enrolling 63 patients suffering from ischemic heart
failure. All of the patients required surgical intervention and
were given shockwave treatment during surgery after the bypass was
established. Half of the patients in the study were put in a
control group and given a sham treatment while the other half were
given cardiac shockwave therapy. The patients given the shockwave
treatment showed significant improvement in left ventricular
ejection fraction (LVEF) as early as six months after the
procedure. After a year, the LVEF improvement measured 11.3% in the
shockwave patients, compared to an LVEF improvement of 6.3% for the
sham group of patients. Such changes in LVEF are known to cause
significant improvements in survival and reductions in heart
failure hospitalizations. In addition, the shockwave patients were
also able to walk significantly farther and reported a higher
quality of life. Some patients who required assistance with
everyday activities were able to again take care of
themselves.
Due to the results of the research, the study was terminated in
agreement with the ethics committee as it was determined to be
unethical to withhold the cardiac shockwave treatment from the sham
group of patients.
"To be able to improve a patient's ejection fraction 36% with a
single shockwave treatment not only revolutionizes the treatment
for ischemic heart disease but lays the foundation for the repair
or regeneration of other organs as well," said SoftWave TRT founder
John Warlick. "We applaud Heart
Regeneration Technologies, Dr. Holfeld, and his team of authors and
researchers for completing this herculean task and finishing the
work we started over a decade ago to prove our patented technology
can reanimate hibernating myocardium. We were excited to see the
results of this extensive study and look forward to continuing our
support for these pioneering researchers."
More than a decade ago, SoftWave TRT's cardiology subsidiary CRT
performed large and small animal trials and treated 10 cardiac
patients with shockwave therapy using its patented cardio
applicator and device interface. These early results provided the
foundation for the clinical trial published in the European
Heart Journal that was based on SoftWave TRT's patented
technology.
"This publication by Dr. Holfeld and his team is the culmination
of over a decade of painstaking scientific research that has been
subjected to the rigorous rules of medical research," stated
reconstructive surgeon and former Chief of Surgery at Piedmont
Atlanta Hospital, Dr. John David
Mullins. "As the effects of shockwaves on soft tissue are
scientifically explained, the possibilities are far reaching."
Dr. Mullins, the U.S.-based Medical Director for SoftWave TRT,
is a leader in the use of SoftWave Therapy for surgical and wound
care applications in the U.S. He added, "Clinical observations have
been made since the mid-1980s, but this well-designed and executed
study is now in publication for critical analysis."
"It's the most earth-shaking science I've ever seen in cardiac
reanimation. The results are incredible and Dr. Holfeld is a
remarkable scientist," said Dr. David
Dean, former Director of the Samsky Advanced Heart Failure
Center at Piedmont Heart Institute. "This is one of the greatest
results of the 21st century for people living with heart
disease."
"Heart disease is the number one cause of death worldwide and
this trial offers hope to these long-suffering patients limited in
their day-to-day lives. Up until now, no technology has been proven
to improve a patient's ejection fraction enough to make a
difference in their daily lives," stated Warlick. "Other therapies
are utilized primarily to prevent a patient's further
deterioration. This publication is a real difference maker, and our
investors who have already committed over $10 million to this project should be proud that
their efforts have finally been published in a high-level journal.
These are the BEST results ever published for the ischemic heart
including all stem cell studies."
Reference list
European Heart Journal (2024, June 20). Cardiac shockwave therapy in
addition to coronary bypass surgery improves myocardial function in
ischaemic heart failure: the CAST-HF trial | European Heart Journal
| Oxford Academic (oup.com)
BBC News (2024, June
20). 'Space hairdryer' regenerates heart tissue in study
(bbc.com)
About SoftWave Tissue Regeneration Technologies
SoftWave TRT, a Alpharetta,
GA-based company, has been at the forefront of
extracorporeal shockwave therapy (ESWT) since its inception in
2004. With a reputation for German engineering excellence, SoftWave
is trusted by leading medical research centers in the United States and around the globe. The
efficacy of the company's technology is backed by hundreds of
published studies. SoftWave's devices have received FDA 510(k)
clearance for connective tissue activation, chronic diabetic foot
ulcer treatment, acute second-degree burn management, pain
reduction, and improved blood supply.
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SOURCE SoftWave TRT