Endologix, Inc (NASDAQ:ELGX), which happens to be top marketer of a wide range of the innovative treatments for aortic disorders has today moved ahead to make the much awaited for announcement. It clearly stated that indeed it had met with the Food and Drug Administration (FDA) and this was of course in regards to its Nellix® Endovascular Aneurysm Sealing System (the Nellix® EVAS System).
A lot of internal analysis has been going on lately and the top provider remains committed to seeking out U.S approval of Nellix® EVAS System. While addressing a press conference, one of the company’s top executives said the undertaking of a confirmatory clinical research with the lately updated Instructions for Use (IFU) and the Gen2 device design was crucial. It is at this point in time being sold in Europe as well as in the rest of the international markets and of course hope lingers that the top provider will gain the much needed approval.
The provider is looking forward to collaborate with FDA in a few coming months on the confirmatory clinical study protocol. There are high expectations that indeed patient enrollment will start in the fourth quarter of this particular year and the PMA approval might take place somewhere around 2020.
The Chief Executive Officer of Endologix, Inc, John McDermott while speaking to a number of news reporters 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.”
The important role the company’s physicians are playing globally cannot be dismissed and still on the same note it is crucial to point to the fact that they have done quite much towards the development of new technologies. Asides from that they have been conducting of a wide range of the clinical studies in a bid to try and come up with the best possible outcomes for the different patients struggling with abdominal aortic aneurysms.
The company has the best interests of its patients as a top priority and will go far and wide to help them lead better and healthier lives.
