MedAlliance’s SELUTION SLR drug-eluting balloon (DEB) receives the …
MedAlliance
GENEVA, April 1 /PRNewswire/
The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides controlled, sustained drug release similar to that found in drug-eluting stents (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) to be granted Breakthrough Device Designation by the FDA for below the knee (BTK) indications in peripheral artery placement on March 4, 2019 and September 25, 2019.
This is an important milestone for MedAlliance. We have successfully completed clinical and preclinical testing required by the FDA and are ready to begin enrolling US patients in a clinical study to support the application for FDA PMA approval. We are pleased that US patients are also benefiting from this breakthrough technology,” commented Jeffrey B. Jump, Chairman and CEO of MedAlliance.
MedAlliance Begins Recruitment for the IDE Randomized Clinical Trial (RCT) SELUTION4BTK (ClinicalTrials.gov Identifier) conducted below the knee: NCT05055297) immediately outside the United States (OUS) and at US centers earlier this summer. The principal investigators of the study are Physicians Ehrin Armstrong (USA), Marianne Brodmann (Austria) and Tjun Tang (Singapore).
SELUTION SLR received CE Mark approval for the treatment of peripheral artery disease in February 2020. The device has shown early clinical results in the treatment of patients with chronic limb ischemia (CLTI) and arterial disease below the knee. In the PRESTIGE study, which was presented at the VIVA Congress 2021 by Dr. Tjun Tang was presented as a late-breaking study, the use of SELUTION SLR in complex BTK lesions was continued for up to 18 months with sustained safety and efficacy results. An additional 75 patients with BTK disease and SELUTION SLR treatment were evaluated in the PRISTINE registry and the results are scheduled to be presented at LINC 2022. Based on the first anticipated data following the use of SELUTION SLR in the treatment of BTK disease, MedAlliance has advanced the design of the SELUTION4BTK RCT to further investigate the safety and efficacy of this applied and to obtain US FDA approval.
SELUTION SLR technology includes unique biodegradable polymer microreservoirs blended with the anti-restenosis drug sirolimus. These microreservoirs ensure a controlled and sustained release of the drug (Sustained Limus Release, SLR). The prolonged release of sirolimus from stents has been shown to be highly effective in both coronary and peripheral vessels. The CAT™ (Cell Adherent Technology) developed by MedAlliance makes it possible to coat the balloons with the micro-reservoirs. These remain attached to the vessel lumen when the angioplasty balloon is inserted.
It is now available in Europe and all other countries where the CE mark is recognized.
Contact:
Richard Kenyan
[email protected]+44 7831 569940
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Original content from: MedAlliance, transmitted by news aktuell