2023-05-31 18:26:39
GENEVA, April 1 /PRNewswire/ – The 12-month results of the SELUTION SFA study were presented at the Japan Endovascular Treatment (JET) Conference in Tokyo. The objective of this study was to evaluate the safety and efficacy of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, when used in endovascular therapy of Again- and unstented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).
The prospective, multi-center, single-arm study enrolled 134 patients treated at 13 sites in Japan. The primary endpoint of 12 months primary target lesion patency was met in 87.9% of patients. TLR (Toll-like receptor) clearance was achieved in 97%, there were no major amputations or deaths, and the thrombosis rate was 0.7%. These results were obtained despite the presence of difficult patients who participated in the study.
“These data show that Limus can be as effective as paclitaxel without the safety issues associated with the latter. This heralds a new era in DCB treatment,” said Dr. Osamu Iida, Osaka Police Hospital Cardiovascular Center, Osaka, Japan.
“I liked that remark from Dr. Iida says, ‘If limus is as effective as paclitaxel but doesn’t pose any safety issues, why wouldn’t anyone use limus?'” commented Jeffrey B. Jump, MedAlliance chairman and CEO. “We’re excited to see that the Japanese 12-month data are fully consistent with the FIM (Functional Independence Measure) conducted by Prof. Zeller 5 years ago Recruitment of subjects for the US IDE-SFA study has started The study will hopefully confirm that patients in the US can reap the same benefits that we have seen in Europe and Japan.”
SELUTION SLR received CE Mark for the treatment of coronary artery disease in May 2020. MedAlliance was the first of the companies to manufacture a drug eluting balloon (DEB) that received FDA Breakthrough Designation from the Federal Drug Agency. Currently, three IDE clinical trials are evaluating SELUTION SLR in the US: in CLTI patients with below the knee disease (BTK), SFA/PPA and coronary ISR. Additionally, MedAlliance received IDE approval for de novo coronary artery lesions in January 2023, adding to the Company’s considerable experience with the SELUTION Again – and the SUCCESS studies in Europe.
MedAlliance’s unique DEB technology involves MicroReservoirs containing a combination of biodegradable polymer mixed with the anti-restenosis drug sirolimus and coated onto the surface of an angioplasty balloon. These MicroReservoirs allow for a controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) allows the MicroReservoirs to be coated on balloons, efficiently transferring them to the vessel lumen where they adhere when delivered via balloon expansion.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, North, Central and South America (excluding the US) and most other countries where the CE mark is accepted. More than 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical studies. Please contact us if your center is interested in this study.
About MedAlliance
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Media contact:
Richard Kenyon, rkenyon@medalliance.com
+44 7831 569940
MedAlliance is a medical technology company that announced a phased acquisition by Cordis in October 2022. The company’s headquarters are in Nyon, Switzerland. MedAlliance specializes in the development of breakthrough technologies and the commercialization of advanced drug combination products for the treatment of coronary and peripheral artery disease. For more information, see: www.medalliance.com
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