2013-09-27 06:02:02 -
At the 13 th EURETINA Congress yesterday, results were presented from a cohort study evaluating the use of a minimally invasive retrobulbar episcleral brachytherapy device developed by Salutaris Medical Devices, Ltd : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. . (SalutarisMD®) to treat wet AMD (age-related macular degeneration), the leading cause of vision loss and blindness. These results were presented by Mr. Kamaljit Balaggan, BSc (Hons), MBBS, MRCOphth, PhD, Vitreoretinal Surgery Fellow at Moorfields Eye Hospital NHS Foundation Trust in London. Moorfields and SalutarisMD announced their forthcoming collaboration in January of this year.
The presentation outlined the feasibility and tolerability of the SalutarisMD investigational treatment for using a single dose of episcleral brachytherapy in conjunction with intraocular anti-VEGF injections. The six subject study produced encouraging results.
At three months, all patients experienced increases in BCVA (best-corrected visual acuity, mean + ETDRS letters). At 24 months, two subjects required no further anti-VEGF injections during follow-up and four continued to demonstrate improved or stabilized BCVA (mean +11.5 letters, with a range of +4 to +25 letters).
The procedure was readily performed [by Drs. Reid Schindler, Leonard Joffe, and Baldassarre Stea, Principal Investigators for the study] and well tolerated with no serious adverse effects. “The device allows patient-specific targeting of the application of radiation through the posterior sclera. This placement allowed for consistent, stable and repeatable control of the distance to the target tissue without violating the intraocular space,” explained Mr. Balaggan. This device is distinguished by its precision and lesion-specific targeting, which enable the retina specialist to deliver precisely localized tissue irradiation, customized for each patient.
The SalutarisMD device is designed to enable retina specialists to administer therapy in the same clinical environment (the physician's office or other outpatient facility) currently used to administer anti-VEGF injections. Placement and treatment are straight forward and performed under local anaesthesia in approximately 15 minutes.
In this study, six patients received 24Gy radiation over 5.5 minutes directly to the macular CNV by positioning the SMD-1 brachytherapy probe adjacent to the macular sclera via a subtenon retrobulbar approach. The probe was then removed. Patients also received concomitant anti-VEGF injections with re-administration as needed. Adverse effects and changes in BCVA and macular thickness were evaluated monthly.
These long-term outcomes utilising SalutarisMD technology show promise for the treatment of wet AMD. Dr. Laurence Marsteller, Managing Director of SalutarisMD, Ltd. said, “We would like to thank EURETINA for supporting our presentation of this research. Our hope is that this technology will ultimately improve the lives of those suffering from this debilitating disease.”
SalutarisMD ® (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a privately held, venture capital funded, clinical-stage medical device company dedicated to developing minimally invasive, patient-centric treatments for vision loss. For more information visit www.SalutarisMD.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
or www.SalutarisMD.co.uk : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
About the EURETINA Congress
EURETINA is a non-profit European scientific society established in 2000 that aims to promote science, research and education. The goal of EURETINA is to be the leading scientific association of retinal specialists in Europe. For more information visit www.euretina.org : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.
Salutaris Medical Devices, Ltd.Suite B212Bessemer BuildingImperial College London SW72AZ+44 (0) 203 282 7166 www.SalutarisMD.co.uk : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
Salutaris Medical Devices, Inc.4330 N. Campbell Ave.Tucson, AZ 85718+1 520-638-7518 www.SalutarisMD.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
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SalutarisMDAmanda Thomas, UK Communications Director+44
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: mailto:firstname.lastname@example.org orJoanne
Vitali, US Communications Director+1 610-518-5405 jvitali@SalutarisMD.com