Switzerland-based medical technology company MedAlliance has enrolled the first patient in its study of SELUTION SLR 014 DEB, designed for the treatment of In-Stent Restenosis (ISR).
The SELUTION sustained limus release (SLR) is a novel sirolimus eluting balloon that offers a controlled sustained release of drug, like a drug-eluting stent (DES).
The device marks the first DEB being accepted by the FDA for its Breakthrough Program, said the company.
SELUTION SLR deploys an advanced technology that involves MicroReservoirs provide controlled and Sustained Limus Release (SLR) of the drug. MicroReservoirs are produced from biodegradable polymer intermixed with the anti-restenotic drug sirolimus.
In addition, the company’s Cell Adherent Technology (CAT) will enable the MicroReservoirs to be coated onto balloons and attached to the vessel lumen during its delivery through an angioplasty balloon.
The SELUTION SLR has been granted CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020.
Currently, it is available in Europe and all other countries where the CE Mark is accepted.
Hartcentrum Hasselt professor Pascal Vranckx said: “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.
“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.”
The study will evaluate SELUTION SLR with either drug-eluting or bare metal stents (BMS)
The randomised, single-blind multicentre study is aimed at evaluating the safety and efficacy of SELUTION SLR in treatment of ISR with either drug-eluting or bare metal stents (BMS), and would support the company’s submission for FDA approval.
The study is planned to enrol up to 418 subjects with BMS or DES ISR involving a native coronary artery with a reference vessel diameter (RVD) of 2.00 to 4.50mm, at approximately 60 sites across both the US and Europe.
The subjects will be randomised to receive either SELUTION SLR or Standard of Care (SOC), a control group with a current DES or a non-drug eluting balloon angioplasty.
Target Lesion Failure (TLF), defined as all cardiac death, along with target vessel myocardial infarction or clinically driven Target Lesion Revascularization (TLR) at 12 months include the primary endpoint for effectiveness of the study.
MedAlliance chairman and CEO Jeffrey B Jump said: “This is a particularly important study for MedAlliance. No coronary drug-eluting balloon has yet been approved in the US, where ISR currently represents 11% of all stent implantations.
“We are excited to introduce this breakthrough technology to help patients around the world.”
