Israeli medical device firm Allium Medical has submitted an application to US Food and Drug Administration (FDA) seeking clearance for the Wirion filter system, which is designed to protect from emboli released during catheterisation procedures.
Allium Medical said the FDA indication is for use of the Wirion system during carotid catheterisation procedures.
The application was submitted in the 510(k) regulatory track based on interim clinical data, which showed the system safety profile was significantly better compared to the control group.
The company started enrolling 120 additional patients in the clinical trial under study protocol.
Allium Medical CEO Asaf Alperovitz said: "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."
Under trial protocol, to meet the primary end-point at this early stage, the company has to meet strict statistical criteria compared to statistical criteria for the full group trial.
According to the statistical method shown in trial protocol, the company did not meet the interim primary end-point that would allow the trial to end at interim.
However, according to the alternative exact binomial statistical method, the company met the trial endpoint at interim stage.
In correspondence between Allium Medical and the FDA, it was stated the alternative exact binomial method proposed by the company will be considered by the FDA following review of the totality of full submission data.
The FDA is expected to respond to the application within 90 days of receiving confirmation that all administrative conditions for the application were met.