Israel’s Allium Medical, a medical device company specializing in minimally invasive technologies based in Caesarea, announced that it has filed an application to the FDA for clearance of the WIRION filter system which helps prevent complications that can arise from cardiovascular operations.
The company boasts that the system is designed to protect from emboli which is released during catheterization procedures. The FDA indication is for use of the WIRION system during carotid catheterization procedures. The application was submitted in the 510(k) regulatory track based on the interim clinical data. In parallel, the company continues the enrollment of 120 additional patients in the clinical study according to the study protocol.
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Asaf Alperovitz, CEO of Allium Medical, stated, “We are taking another step towards FDA clearance for marketing the Gardia unique filter in the US. The application is based on the interim clinical results that include data from 120 out of the planned 240 patients and demonstrate that the safety profile (the primary end-point of the study) is significantly better compared to the control group (that includes data from cleared US products of global companies). Following our correspondence with the FDA we decided to submit the application and in parallel continue patient enrollment beyond the patients already treated. Based on the interim results, we believe that the probability of successfully meeting the study primary end-point for a full cohort of 240 patients is high, assuming the Company will be obliged to conduct it.”
Allium stated that the interim clinical data submitted to the FDA clearly demonstrate that the system safety profile, the primary end-point of the study, is significantly better compared to the control group. According to the study protocol, in order to meet the primary end-point at this early stage, the Company has to meet strict statistical criteria compared to the statistical criteria for the full cohort study.
According to the statistical method presented in the study protocol, the company did not meet the interim primary end-point that would allow its ending the study at interim. However, it asserts, according to the alternative exact binomial statistical method, the Company met the study endpoint at interim. In the correspondence between the Company and the FDA it was stated that the alternative exact binomial method proposed by the company will be considered by the FDA following the review of the totality of the full submission data.