MedAlliance
GENEVA, April 1 /PRNewswire/
The first US patient was enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLR™ in the treatment of superficial femoral artery (SFA) and proximal popliteal artery (PPA) occlusive disease and was designed to support FDA approval. It follows Investigational Device Exemption (IDE) approval in the US in August 2022. SELUTION SLR is the first and only Limus Eluting Drug Eluting (DEB) balloon to receive IDE approval from the FDA for SFA and PPA indications .
SELUTION4SFA is performed at over 30 centers in the US and an additional 10 centers worldwide. The study will enroll 300 patients with the aim of demonstrating the superiority of SELUTION SLR over balloon angioplasty (POBA). The primary efficacy endpoint is primary target lesion patency at 12 months and the primary safety endpoint is freedom from death at 30 days. Enrollment in the study will be completed by the end of 2023.
“We are excited to introduce the first sirolimus DEB to US patients and expect rapid enrollment into this important study,” said Dr. Jay Mathews, Co-Principal Investigator, Manatee Memorial Hospital, Bradenton, Florida. “We hope to learn how this technology can benefit patients with complex peripheral artery disease.”
“We are pleased to be conducting our third IDE study in US patients and look forward to the results of these three studies and future IDE studies,” added Jeffrey B. Jump, MedAlliance chairman and CEO.
SELUTION SLR received CE certification for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug eluting balloon company to receive breakthrough designation from the FDA. Currently, SELUTION SLR is being evaluated in three IDE clinical trials in the US: in CLTI patients with BTK disease, SFA/PPA; and coronary ISR. Additionally, in January 2023, MedAlliance received IDE approval for de novo coronary artery lesions. This complements the extensive experience that the company has gained with the SELUTION DeNovo and SUCCESS studies in Europe.
MedAlliance’s unique DEB technology is MicroReservoirs containing a combination of a biodegradable polymer and the anti-restenosis drug sirolimus that are 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 onto balloons and efficiently adhere to the vessel lumen when delivered via balloon expansion.
SELUTION SLR is commercially available in Europe, Asia, Middle East, North and South America (excluding the US) and most other countries that accept the CE mark. 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 participating in this study.
About MedAlliance
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 developing breakthrough technologies and commercializing advanced drug combination products for the treatment of coronary and peripheral artery disease. For more information, see: www.medalliance.com.
Media contact:
Richard Kenyon
[email protected] +44 7831 569940
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