Koya Medical recently announced that full results from the TEAYS clinical study have been published in the Journal of Vascular Surgery (JVS).
The data highlight superior efficacy and improved quality of life for patients suffering from lower extremity lymphoedema with Dayspring, a novel non-pneumatic compression device (NPCD), compared to advanced pneumatic compression devices (APCDs).
Dayspring met the study’s primary and secondary outcome measures and showed a broad range of superior clinical benefits for patients using the device compared to using an APCD, a press release reports. These results are consistent with prior studies’ findings associated with Dayspring for the treatment of lymphoedema.
“The introduction of Dayspring represents a clinically differentiated and therapeutically distinct advancement in the treatment of lower extremity lymphoedema,” said Michael Barfield (University of Tennessee Health Science Center, Nashville, USA), lead investigator. “Patients participating in the TEAYS study expressed a strong preference for the Dayspring treatment over advanced pneumatic compression devices. The ability for patients to remain mobile while receiving effective treatment is a game-changer in improving adherence and overall quality of life.”
Key findings from the TEAYS study include:
- Efficacy: Patients using Dayspring experienced a mean limb volume reduction of 369.9mL, significantly greater than the 83.1mL reduction observed in the APCD treatment arm.
- Quality of life: Significant improvements were noted in the overall Lymphedema Quality of Life Questionnaire (LYMQOL) scores for Dayspring users, with a mean improvement of 1.01 compared to 0.17 for APCD users. Key functional sub-scores such as symptoms, appearance, and function also favored Dayspring.
- Adherence: Dayspring users demonstrated an adherence rate of 81%, significantly higher than the 56% adherence observed in the APCD group.
- Safety: No device-related adverse events were reported for either treatment, highlighting the safety of Dayspring.
The TEAYS (Treatment effectiveness of a non-pneumatic compression device versus an advanced pneumatic compression device for lower extremity lymphoedema swelling) study is Koya Medical’s eighth clinical study evaluating Dayspring for the treatment of lymphoedema since its US Food and Drug Administration (FDA) clearance in 2021. The TEAYS study was a prospective, multicentre, randomised, single-crossover clinical trial conducted across nine sites in the USA. It involved 71 patients with confirmed lower extremity lymphoedema, comparing the treatment effectiveness and patient adherence between Dayspring and APCDs.
