Endologix, Inc (NASDAQ:ELGX), which happens to be one of the leading developers and marketers of top end innovative treatments for aortic disorders has today moved forward to make the much awaited announcement. It actually revealed to all the concerned parties and the general public as well that it had indeed resolved to meet up with the Food and Drug Administration (FDA) regarding its Nellix® Endovascular Aneurysm Sealing System (the Nellix® EVAS System).
Just like any other high end company, the provider remains very much dedicated to business success and it is the reason it actually allocated a lot of its resources in coming up with the product .According to one of the company’s top executives, the product will help patients around the worlds in a major way and what they are looking forward to at the moment is just the “go-ahead” from FDA. The moment the product gets approved they will do all within their means to avail it to the general market where various patients will be able to take advantage of the product to face the health complications.
Another top official has asserted on the great need to move ahead and actually conduct some confirmatory clinical study and in line with this will be putting into account the recently Gen2 device design and the Use (IFU) which is at this point in time being sold out in different reason in Europe as well as in other parts of the world markets.
The news trickling in at the moment is that the company’s board of directors has agreed upon getting into a collaboration that with FDA and there is indeed great hope that by the fourth quarter of this particular year they will have kick started the patient enrollment process.
Some close sources to the company have made a lot of revelations in the recent past, but the latest one has been about the PMA approval which has been indicated to actually start in 2020.
The Chief Executive Officer of Endologix, Inc, John McDermott while addressing a press conference said, “While the timeline has shifted from our projections, we appreciate the FDA’s collaboration as Nellix® EVAS proceeds in the regulatory process. We have evidence that our previously updated Nellix® IFU provides excellent patient outcomes and look forward to starting the confirmatory clinical study with our Gen2 device.”
