Koya Medical (“Koya”), a medical technology company advancing evidence-based therapies for vascular disease, presented two newly published clinical studies for the treatment of lymphedema and venous disease with its Dayspring® active compression system that showed significant improvements in patient outcomes.
Stanley Rockson, M.D., cardiologist and professor in the Falk Cardiovascular Research Center at Stanford University School of Medicine and principal investigator of the studies, presented the multi-center, randomized, crossover head-to-head trial (NILE) published in the Journal of Vascular Surgery and an open-label study of the Dayspring system for the treatment of lymphedema and venous diseases in the lower extremities in Scientific Reports, Nature at the American Vein and Lymphatic Society (AVLS) 2022 Annual Congress, held October 13-16, 2022, in New Orleans, Louisiana.
Dayspring is the first non-pneumatic active dynamic compression treatment designed for patient mobility and cleared by the U.S. Food and Drug Administration (FDA) to treat lymphedema and chronic venous conditions.
Safety and Effectiveness of a Novel Non-Pneumatic Active Compression Device for Treating Breast Cancer-Related Lymphedema, a Multi-center Randomized, Crossover Trial (NILE) Results
Evaluated the safety and efficacy of the Dayspring nonpneumatic compression device (NPCD) for treating lymphedema versus an advanced pneumatic compression device (APCD) in 50 women with unilateral breast cancer-related lymphedema.
Summary of Key Results:
- Statistically significant difference in overall QoL (LYMQOL) with NPCD (Dayspring) 2.44 points improvement compared to APCD at Day 28 (p<0.05)
- Statistically significant difference in mean reduction in edema volume with NPCD 64.6% compared with 27.7% for APCD at Day 28 (p < 0.05)
- Statistically significant difference in overall response rate with NPCD 88% compared with 42% for APCD at Day 28 (p<0.05)
- Statistically significant difference in treatment adherence, 95.6% for NPCD compared with 49.8% for APCD (p<0.01)
- 86% of participants reported reduced use of compression sleeves when treated with NPCD compared with 0% when using APCD
- Overall patient satisfaction 90% for NPCD compared with 14% for APCD
- No device-related adverse events were reported during the study
Full manuscript published in the Journal of Vascular Surgery Venous and Lymphatic Disorders. Open access here
A Non-Randomized, Open-Label Study of the Safety and Effectiveness of a Novel Non-Pneumatic Compression Device (NPCD) for Lower Limb Lymphedema Results
A multi-center, open-label, 12-week clinical study of 24 patients with primary or secondary unilateral lower extremity lymphedema (LEL) that evaluated changes in limb edema and quality of life (QoL) following treatment with the Dayspring device.
Summary of Key Results:
- After three months of use, patients experienced mean improvements in lymphedema quality of life questionnaire (LYMQOL) compared with baseline (p<0.05).
- Limb volume improved (up to 50% reduction in edema) with Dayspring use, with an average reduction in affected limb edema of 39.4%
- No device-related adverse events were reported during the study
Full manuscript published in the Nature, Scientific Reports. Open access here
About Lymphedema
An estimated 20 million Americans live with lymphedema, a progressive, incurable condition where a buildup of protein rich fluid causes painful swelling in the arm, leg, and/or other regions of the body. For most, lymphedema requires lifelong maintenance and various levels of therapy to control swelling and pain. Lymphedema is commonly caused by cancer—such as breast cancer, uterine cancer, prostate cancer, vulvar cancer, ovarian cancer, lymphoma, melanoma and cancers of the head and neck—and its treatment due to damage of the lymph system from the tumor itself, radiation treatment or the surgical impairment of lymph nodes.
About Dayspring®
Dayspring is a prescription, non-pneumatic compression system designed to deliver customizable active compression while allowing patients to remain mobile during treatment.
Dayspring is the only non-pneumatic compression therapy supported by published randomized head-to-head comparative evidence demonstrating superior limb volume reduction, disease-specific quality of life, treatment adherence and patient preference versus an advanced pneumatic compression device.
Dayspring is FDA-cleared for the treatment of lymphedema, phlebolymphedema, venous insufficiency and other chronic edema-related conditions affecting the upper and lower extremities.
About Koya Medical
Founded in 2018 and headquartered in Dallas, Koya Medical is a medical technology company developing a portfolio of evidence-based treatments designed to improve clinical outcomes and patient experience in vascular disease.
Reference:
1. What is lymphedema? American Cancer
Society. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/lymphedema/what-is-lymphedema.html. Accessed September 26, 2022.
