According to the National Institutes of Health, Laser therapy has widely attracted experts’ attention in medical sciences for its proven benefits in areas including (but not limited to) regenerative medicine, cosmetic, dentistry, neurodegenerative diseases and an ever-growing list of disorders. Basic concepts and various kinds of lasers which are applied in medicine report laser therapy’s response to various fields of medicine such as pain reduction and wound healing in several other body organs at high potential for success. [1]
REGULATORY APPROVED TECHNOLOGY
Since the early 1970s, lasers have been categorized in four classes with two subclasses based on a laser’s wavelength and maximum output of power. The classes group lasers according to their ability to produce damage in exposed people, from class 1 (no hazard during normal use) to class 4 (severe hazard for eyes and skin). [Sourced from AspenLaser.com].
MAINTAINING SAFETY COMPLIANCE
Our research group selected the Aspen Laser device based on its claimed effects and advancements. We have confirmed the Apex laser system to meet FDA clearance as a Class II Medical Device and a Class IV Laser (CDRH) and has been determined to meet market standards as a clinically safe and approved device.
This performance review as conducted by Bard Diagnostics and IHRC (as well as all reviews of this kind) is an anecdotal test drive of non-invasive health technologies that have successfully acquired regulatory approvals for public use. Its main objective is to publish reports supportive of our clinical findings for public access to the professional communities and is distributed for informational use only. The use of the aforementioned device under this performance study formally complies to the regulatory approved uses of this device and the Aspen Laser certified training course. Each treatment is supervised by a board-certified medical professional within a state licensed medical practice, thus did not require the need for IRB approval (Institutional Review Board) and applications undergone in this test.
For this research project, the research imaging director opted to advance the quantitative data gathering by employing the elastogram feature of the ultrasound system. Dr. Bard recognized the capacity of a certain model- the MINDRAY™ RESONA 7 to be the ideal 'workhorse' of choice. In pursuit of physiological reactions to the PBMT energy induction, "we may anticipate fibrosis or hardness or stiffness... scan ning musculature enables us to capture measurable effects of the light/energy induction in the form of abnormal color which tracks with the value of the hardness or physical elastic change in the muscle fibers. The elastography scale (upper left of screen) from 100 represents very hard tissue or muscle spasm or fibrosis down to zero, indicating fat or soft tissue. From this test, the elastogram reading allows for additional comparative studies alongside standard ultrasound and 3D Doppler Blood Flow biometric readings.
CASE STUDY #7: PSORIASIS / FOOT & ELBOW
FOOT: laser compare 3-11-23. Hx: Right foot pain Sonofluoroscopy of the plantar and hallux tissues was performed in multiple scan planes with 18 and 20 MHz transducer frequencies. Power and spectral Doppler was performed. Mild tendinitis unchanged.
3D DOPPLER: Normal posterior tibial and pedal arterial Doppler flows. No regional hyperemia. Triphasic waveforms. Peak vel 11cm/s. Hyperemia decreased to the dip joint. 3D shows abnormal dermis decreased from 2.1mm to 15mm.
ELASTOGRAM: Decreased edema psoriatic plaque (light blue) with early fibrosis of talar ligament (yellow).
IMPRESSION:
- Decreased Dermal Inflammation
- Mild Ligament Fibrosis And
-Tendinitis
PATIENT NARRATIVE
“I have been suffering from PSORIASIS since I was 25. Periodically my psoriasis gets inflamed and gets very scaly and very itchy. (When I scratch, which is often it gets worse). I received my first treatment with the (Aspen) Laser back in March, 2023 and I received various treatments afterward. I continue to have this laser treatment on my right foot, which is the worst and on my right elbow. Lately, the scaling seems much flatter. I don't know whether it's the laser or some of the other home treatments I'm doing for myself… but it seems to be quite a bit improved”.
CASE STUDY #9: EDEMA / L HAND
5-23-2023 1:53:23pm
PATIENT NARRATIVE
"Around 5-9, I fell down a flight of stairs and landed on my hands causing major bruising and significant inflamed swelling on both. I used ice on it frequently + 600mg ibuprofen and counted on nature to make it go away."
"On 5/23, I experienced a 15 minute demo treatment of the (Aspen) laser on my left hand only. I would say like right away I noticed a difference. I had more flexibility in my wrist right away. It just continued to get better and better (from the treatment). I was able to sleep through the first night without any pain when I rolled over on my hand. The next day, the purple began to fade and it started to turn yellow- indicating recovery. The other hand (untreated) was still purple. It was interesting to see the comparison and that the hand that was treated was the worst hand. I could see the recovery on the spot! And by the second or third day, it was completely gone- and the other hand was still purple. As an athlete, I'm no stranger to bruises and bumps from things like falling off a bicycle. My one experience with this laser therapy was the fastest recovery...I would say by double, if not triple, because the purple started going away right away".
Throughout this series of performance test drives, the Aspen Laser provided surprisingly high marks from the vast majority of test subjects who received its treatments. Both the patients and the ultrasound scans reported close-to-immediate (positive) response for their disorders. With over 75 volunteer test subjects, a significant percentage stated remarkable improvement and recovery (of their disorders) within the time of the treatment and/or days thereafter.
As originally conceived, use of ultrasound and elastography function allowed our research team to visually identify the Aspen laser's efficacy. Moreover, this review gave us the opportunity to explore the wide range of scanning and investigative capabilities of the elastographic paradigm under the studies of musculoskeletal and inflammatory disorders. Additional case studies under this performance test is available in upcoming IHRC reports.
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SPECIAL THANKS
IHRC, Health Tech Reporter and the Bard Diagnostic Imaging team wish to give special thanks to all the clinical technicians and volunteers who offered their time and support in completing this performance test study. We further express our deep appreciation to the generosity and innovative vision of Aspen Laser CEO & President, Charles Vorwaller for donating the Aspen Laser Apex device to this study. Further special thanks also belong to Michelle Carter, Frank Marcantonio and the entire team at Mindray NA for their endless support in the facilitation and use of their remarkable imaging technology and further education in ultrasound advancement. Additional thanks belong to Abdellatif Zerzif (ultrasound & laser tech) for his stellar professional performance in managing both technologies and patient care. Also, extended thanks belong to research advisors Lennard Gettz, Dr. Noelle Cutter, Dr. Roberta Kline and Dr. Leslie Valle-Montoya for their support throughout the coordination and execution of this project, including the development of its final reports.
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