First Patient Enrolled in Olympus Study of the SOLTIVE Laser System
Study Seeks Evidence for the "Game-Changing" Performance of New Thulium Fiber Laser Technology for Lithotripsy
Dec 21, 2020, 10:17 ET
CENTER VALLEY, Pa., Dec. 21, 2020 /PRNewswire/ -- Olympus announced today the first patient enrolled in an international study to collect real-world evidence on the performance of the new SOLTIVE™ Premium SuperPulsed Laser System (SOLTIVE Laser System) for breaking up kidney and ureteral stones. Dr. Wilson Molina, Professor of Urology at the University of Kansas School of Medicine, performed the first case as part of the trial.
Many physicians have described this new application of thulium fiber laser technology as game changing, and this study sets out to provide more data supporting that assessment. "This new laser is exciting because it is going to change the way we treat stones. With a completely different way of delivering the laser energy to the stone, we are now able to fragment stones very quickly and into much smaller pieces, like the fine sand you'd find at a white sandy beach," said Dr. Ben Chew, Associate Professor in the Department of Urologic Sciences at the University of British Columbia in Vancouver and co-Principal Investigator of the trial. "With SOLTIVE, urologists may be able to treat bigger stones endoscopically, which means we can avoid having to access the kidney through an incision in the patient's back. Patients and physicians benefit because the procedure is more efficient, and the technique for treatment is much less involved."
Study to Measure Stone-Free Rate
The primary goal of the study is to measure the number of patients who remain free of stones after three months following treatment. The current stone-free rate using older technology like Holmium YAG is between 65 and 92 percent, with the rate dependent upon the number of stones and the stone size, location, and composition. This study seeks evidence demonstrating that the SOLTIVE Laser System has a higher stone-free rate because of its ability to break up the stones into fine dust-like particles. Research from Dr. Olivier Traxer, Professor of Urology at the University Sorbonne, Paris, Director of the Minimally Invasive Surgery Department at Tenon Hospital, and co-Principal Investigator of the trial, shows that the thulium fiber laser overcomes the limitations of older lithotripsy laser systems such as the Holmium YAG.i
"We are looking forward to having the data to prove what we already understand to be true based on bench tests and early clinical cases," said Dr. Traxer. "In my initial experience with the SOLTIVE Laser System, we are going almost twice as fast and using a third less total energy to obtain the same results in stone ablation compared to the Holmium YAG system. It's clear to me that we are doing a better job with the thulium fibers."
Up to 450 patients will be enrolled in the post-market registry study that will be conducted at up to five centers in the U.S., three centers in Europe, and one center in Canada. Those interested in learning more about the study should visit: https://clinicaltrials.gov/ct2/show/NCT04556201
"As one of the first physicians to test this new technology, I am thrilled to have treated the first patient as part of this important study," said Dr. Molina. "The SOLTIVE Laser System is silent, portable, and user friendly, and it performs wonderfully. I can't think about any clinical scenario for intracorporeal lithotripsy that can't be managed with this system."
Understanding fully the capabilities of this system will help provide better and more consistent patient care as this new technology is adopted more broadly.
About the SOLTIVE Laser System
- Dusts stones in half the time it takes other laser systems, while also creating fine dust that is easily removed.
- Virtually no retropulsion at select settings, which means that the urologist can more effectively target the stone and more efficiently deliver the laser energy to its target.ii
- Compact footprint at an eighth of the size of other Holmium YAG systems, which means that it fits on a small cart and saves critical OR space.
- Runs more efficiently, requiring only a standard 110-volt power outlet. There is no longer a need to re-wire your operating room with higher amperage and voltage outlets.
- Considerably quieter than other laser systems, generating 50 percent less noise than the Holmium YAG when measured at comparable settings.ii
- Cleared for use in the U.S., Canada and Europe.
"Olympus seeks to develop products that improve the quality of life for patients and the physicians treating them. The SOLTIVE Laser System promises to improve procedural efficiency while also improving the experience of physicians performing lithotripsy," said Gabriela Kaynor, Global Head of the Therapeutic Solutions Division for Olympus Corporation. "This study will show us how this new laser system may improve patient outcomes."
For more information about the SOLTIVE Laser System, visit: RockUroWorld.com.
About Olympus
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries.
Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments. For more information, visit https://medical.olympusamerica.com/.
i Traxer, O., Keller, E.X. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol 38, 1883–1894 (2020). https://doi.org/10.1007/s00345-019-02654-5
ii Test data on file
SOURCE Olympus Medical Systems Group
