MedAlliance Leads US Sirolimus DEB Race: First US Patient to Coronary…
MedAlliance
GENEVA, April 1 /PRNewswire/
The first US patient has been enrolled in the SELUTION4ISR study at MedStar Washington Hospital Center, which is evaluating SELUTION SLR™ in support of FDA approval. This milestone follows the Investigational Device Exemption (IDE) approval in the US in October 2022. restenosis (ISR).
“We are very pleased to have enrolled our first patient in the United States,” said Dr. Don Cutlip, co-principal investigator of the IDE-SELUTION4ISR study and chief medical officer at the Baim Institute for Clinical Research. “This study addresses the significant unmet need for a treatment for the ongoing problem of in-stent restenosis without the addition of a metallic stent.”
“This is an exciting day for percutaneous coronary interventions in the United States. With the exception of the USA, the drug-eluting balloon catheter is the worldwide standard of care for ISR. Treatment of coronary ISR is challenging and making DEB technology available through a well-designed and conducted randomized clinical trial is the next step. This study is now underway and that is great for our patients,” added Co-Principal Investigator Prof. Roxana Mehran, Mount Sinai Professor of Cardiovascular Clinical Research and Clinical Trials.
“This is another significant milestone for MedAlliance: we were the first to receive FDA IDE clearance for a sustained-release balloon catheter. We were the first to treat a patient with peripheral vascular disease in the US and are now the first to treat a patient with coronary artery disease in the US. This is the culmination of a multi-year R&D program that has delivered comprehensive preclinical data that meets the US FDA’s very high standards,” added Jeffrey B. Jump, Chairman and CEO of MedAlliance. “We are very pleased with the high level of market acceptance we are experiencing in Europe, Asia and South America and we look forward to entering the US market following FDA approval.”
Recruitment for the IDE-SELUTION4ISR-FDA Coronary Study is ongoing outside the US and additional US centers will soon join MedStar Washington Hospital Center following this first US enrollment. (ClinicalTrials.gov identifier: NCT04280029).
MedAlliance received IDE approval for de novo coronary indications on January 6. one of the DeNovo-OUS SELUTION study will enroll more than 800 of the 3,326 patients enrolled in this landmark randomized coronary study comparing the SELUTION SLR (DEB) vs. sirolimus-eluting coronary stent (DES) treatment strategy.
SELUTION SLR received CE Mark for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon catheter company to receive Breakthrough Device Designation from the FDA. In addition to the below the knee (BTK) and superficial artery occlusive disease (SFA) indications for which the company received FDA IDE clearance in May and August 2022, MedAlliance received in October received IDE approval for in-stent coronary restenosis (ISR) in 2022 and for de novo coronary artery lesions on January 6, 2023, adding to the extensive experience the company has with the SELUTIONDeNovostudy in Europe.
MedAlliance’s DEB express technology is microreservoirs containing a blend of a biodegradable polymer and the anti-restenosis drug sirolimus that are applied as a coating to the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of drug for up to 90 days. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) allows the microreservoirs to be applied to balloons and efficiently rendered adherent to the vessel lumen as they are delivered through balloon expansion.
The SELUTION SLR-014-PTCA (Percutaneous Transluminal Coronary Angioplasty) is marketed in Europe, Asia, the Middle East and the Americas (outside the US) and most other countries where the CE Mark is recognized. available in the stores. More than 10,000 units have been used to treat patients in clinical practice or as part of clinical trials. Centers interested in participating in this study should contact MedAlliance.
About MedAlliance
MedAlliance is a medical technology company that announced a phased acquisition by Cordis in October 2022. MedAlliance is headquartered in Nyon, Switzerland. The company specializes in the development of breakthrough technologies and the commercialization of advanced drug combination products, initially for the treatment of coronary and peripheral artery disease. You can find more information on: www.medalliance.com
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