Lumenis® Announces the Initiation of a Clinical Study into the Efficacy of Selective Retina Therapy (SRT) in Diabetic Macular Edema (DME)
Lumenis® Ltd. a global developer, manufacturer and marketer of laser, light-based and radiofrequency devices for ophthalmic, surgical and aesthetic applications, announced today the initiation of a clinical study into the efficacy of Selective Retina Therapy (SRT) in Diabetic Macular Edema (DME). The study will take place at the Tel Aviv Medical Center in Israel, under the leadership of Prof. Anat Loewenstein MD.
Valley Lee, MD (PRWEB) November 5, 2009
Lumenis® Ltd. a global developer, manufacturer and marketer of laser, light-based and radiofrequency devices for ophthalmic, surgical and aesthetic applications, announced today the initiation of a clinical study into the efficacy of Selective Retina Therapy (SRT) in Diabetic Macular Edema (DME). The study will take place at the Tel Aviv Medical Center in Israel, under the leadership of Prof. Anat Loewenstein MD.
Dov Ofer, Lumenis’ President and Chief Executive Officer stated: “We are proud to be yet again at the forefront of ophthalmic laser innovation with the clinical evaluation of Selective Retina Therapy (SRT). That is, after all, only one of the privileges reserved for the company that pioneered the very first Argon Laser photocoagulator in ophthalmology, along with a history of innovations that literally have transformed the way ophthalmologists practice medicine worldwide.” Mr. Ofer continued and added that “we are also very proud to be collaborating with Prof. Loewenstein who is internationally recognized and respected for her efforts as a leading retina specialist with a long-list of medical accomplishments.”
In a statement on SRT, Prof. Anat Loewenstein commented: “Ophthalmic lasers have been playing a key role in the treatment & management of various retinal pathologies for many years now – however, not without negative side-effects. In the case of standard lasers, treatments usually result in deleterious thermal damage to neurosensory retinal tissue that is integral to healthy vision. As a retina surgeon, I think Lumenis SRT technology represents significant potential over conventional lasers, as it selectively targets the RPE layer without damaging the highly-sensitive neurosensory retina layer; thereby avoiding scotomata (blind spots) in the treated areas. However, what excites me the most is the potential benefits this primarily represents to our patients; a pain-free treatment that does not further impair vision and that may potentially improve conditions that rob the eyesight of tens of millions of people worldwide. Based on the data we have seen, Lumenis SRT technology appears to have the potential to become that treatment and this is what we are going to investigate”, concluded Prof. Loewenstein.
“The Lumenis SRT technology holds significant potential into the treatment of various retinal pathologies. Our most current knowledge shows that the retinal pigment epithelium plays a key role in several ocular conditions that negatively impact the vision of millions of patients worldwide. Being able to selectively target that layer of cells, without causing any thermal damage to adjacent tissues, induces a certain biological response that may one day give hope to these patients,“ stated Dr. Pazit Pianka MD, an ophthalmologist and the Lumenis Vision Medical Director.
“With this new investigation into the clinical efficacy of Lumenis SRT technology, Lumenis once again reaffirms its decades-long commitment to excellence and innovation in ophthalmic laser technology,” said Mr. Lloyd Diamond, Senior VP & General Manager of Lumenis Vision, the Ophthalmic Business Unit of Lumenis Ltd. “Approximately 10 years ago our company launched Selective Laser Trabeculoplasty (SLT) based on the novel concept of selective photo-thermolysis. During that time we have witnessed our technology transform into a leading, clinically-proven, first-line therapy for POAG and a viable alternative to eye drops. We believe SRT has the potential to revolutionize retina therapy, similar to the way SLT revolutionized glaucoma management. This new study will help us ascertain that fact” concluded Mr. Diamond.
About the Clinical Trial:
The clinical trial will be conducted under the direction of Prof. Anat Loewenstein MD, who is an associate Professor of Ophthalmology & the Vice-Dean of the Sackler Faculty of Medicine at the Tel Aviv University, and the Director of the Department of Ophthalmology at the Tel Aviv Medical Center in Israel. The prospective study, which includes 102 patients (102 eyes), was designed to evaluate the effectiveness of Lumenis Selective Retina Therapy (SRT) treatment in diabetic macular edema. The duration of the study is two years with patient follow up at 4, 8, and 12 months post-op.
All patients will receive treatments with the Lumenis SRT laser that was developed by Lumenis Ltd., in collaboration with its research partner MLL (Medizinisches Laserzentrum Lübeck) in Lübeck, Germany. Lumenis holds propriety rights for this technology.
About Selective Retina Therapy (SRT):
Selective Retina Therapy (SRT) is a relatively new laser technique which selectively targets the Retinal Pigment Epithelium (RPE) while sparing the neural retina. Several macular diseases are thought to be caused and/or significantly exacerbated due to reduced function of the RPE cells. In light of that, a method for the selective destruction of the underperforming RPE cells without causing adverse effects to the choroid and neurosensory retina (especially to the photoreceptors layers) is hypothesized to halt the progression of those diseases and/or reverse some of its deleterious effects.
The selective effect on RPE cells, which absorb about 50% of the incident light due to their high melanosome content, has been previously demonstrated using the Lumenis SRT laser. By irradiating the fundus with a train of 1.7 micro-second laser pulses it is possible to achieve high peak temperatures around the melanosomes, which leads to a destruction of the RPE, with only a low sub-lethal temperature increase in adjacent tissue structures. This process leads to the multiplication and migration of healthy RPE cells from the periphery which, in turn, help metabolize and improve the overall retina tissue health.
The Lumenis SRT laser was specifically designed to perform selective RPE targeting. This is accomplished by a green (frequency doubled Nd:YLF, 527nm) laser that emits 1.7 microsecond (¼s) pulses at a repetition rate of 100 Hertz (Hz). This low average power, delivered in a train of pulses, confines the laser treatment to the cells containing the target pigment or chromophores, in this case the melanin granules in the RPE cells, thereby achieving selective damage to these particular cells.
About Lumenis:
Lumenis, the world’s largest medical laser company, is a global developer, manufacturer and distributor of laser, light-based and radiofrequency devices for surgical, aesthetic and ophthalmic applications, with more than 800 employees worldwide. Lumenis has over 250 patents, over 75 FDA clearances, an installed base of over 80,000 systems and presence in over 100 countries. Lumenis endeavors to bring the finest state of the art technology products to the market, fulfilling the highest standards of excellence, quality and reliability. Consequently we are able to deliver premium value and service to our customers. Lumenis’ name is derived from Latin meaning “Light of Life”, highlighting the light which is the basis of our technologies used to enhance life. For more information about Lumenis and its products, please go to: www. lumenis. com.
For further information contact:
Michelle Maydan
Director of Corporate Communications
1-866-569-0597
+972-4-959-9004
E-mail: mmaydan (at) lumenis. com
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