Authorization

World's First FDA IDE Coronary Patient Treated With a DEB

NYON,A Switzerland, July 11, 2020 /PRNewswire/ --A  MedAlliance has announced enrollment of the first patient in its study of SELUTION SLRa?? 014 DEBA for the treatment of In-Stent Restenosis (ISR). This is the first DEB accepted by the FDA for its 'Breakthrough Program'. The SELUTION SLR (Sustained Limus Release) is a novel sirolimus eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES). The objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy of SELUTION SLR in treatment of ISR with either drug-eluting or bare metal stents (BMS). The study will support submission for FDA approval. "This first patient was treated with the investigational device after suffering a DES ISR. We are delighted to be able to offer our patients this promising new technology," commented Professor Pascal Vranckx, Hartcentrum Hasselt, Belgium. "We are excited to participate in a study that validates this novel technology for ISR treatment. SELUTION SLR may provide an additional treatment option for these patients. We very much look forward to the results of this study." Up to 418 subjects will be recruited into the study at approximately 60 sites across both the US and Europe. Subjects need to have a BMS or DES ISR involving a native coronary artery with a reference vessel diameter (RVD) of 2.00 a?? 4.50 mm to qualify for inclusion. Subjects will be randomized to receive either SELUTION SLR or Standard of Care (SOC) a?? a control group with a current DES or a non-drug eluting balloon angioplasty. The primary endpoint for effectiveness of the study is Target Lesion Failure (TLF): defined as all cardiac death; target vessel myocardial infarction; or clinically driven Target Lesion Revascularization (TLR) at 12 months.
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