Endologix Inc. is on a path to expanding its Ovation platform through its ELEVATE IDE clinical study. The Irvine, Calif.-based company said the 75-patient trial will evaluate the safety and effectiveness of its Ovation Alto abdominal stent graft system for the repair of infrarenal abdominal aortic aneurysms (AAA). The company said the first patients have already been treated in the trial.
Ovation Alto broadens Endologix's reach into the endovascular aortic repair (EVAR) market and provides treatment options for patients with complex AAAs. The device is specifically targeted toward patients with very short or otherwise challenging aortic neck anatomy.
"The study is expected to have a broadest indication of any infrarenal endovascular AAA device in the world," said John McDermott, Endologix president and CEO, during a recent earnings call. He added that enrollment should be closed by the end of this year.
Ovation Alto is the newest device in the Ovation platform of abdominal stent graft systems, which has clinical results reported from the Ovation global pivotal trial and European Post-Market Registry. The company said Ovation Alto has conformable O-rings with Customseal polymer that have been repositioned near the top of the endograft, providing a seal just below the renal arteries.
Endologix gained access to the Ovation platform when it acquired Santa Rosa, Calif.-based Trivascular Technologies Inc. for $211 million nearly two years ago. (See Medical Device Daily, Oct. 28, 2015.)
Trivascular first gained FDA approval for the Ovation Platform back in 2011.
TURBULENCE IN THE PRODUCT LINE
Endologix has faced and corrected several issues regarding its product pipeline in the last few months.
In December, the company placed a temporary hold on shipments of its AFX endovascular AAA system due to a manufacturing problem. (See Medical Device Daily, Dec. 28, 2016.) Earlier this year, Endologix removed the hold on all sizes of the AFX system and some sizes of its AFX2 device. (See Medical Device Daily, Jan. 3, 2017.)
The hold came shortly after the company had its CE mark for AFX suspended, as well as the receipt of an FDA request for two-year patient follow-up data for the Nellix endovascular aneurysm sealing system. (See Medical Device Daily, Nov. 18, 2016.) During an earnings call in February, McDermott said that CE mark for AFX and AFX2 had been reinstated.
But there was still damage done to the firm's shares, which dipped about 27 percent late last year and the firm saw a slight decline in its 4Q16 earnings.
The firm's revenue dropped about 3 percent for 4Q16, when compared to the previous quarter. For the full year of 2016, total revenue was $192.9 million, a 1 percent increase compared to combined revenue of $190.6 million in 2015.
If Endologix could score an FDA approval for Nellix, it would give the company another tool to compete with other players in the EVAR market, including Cook Medical, Medtronic plc and W.L. Gore Associates.
"We plan to meet with FDA in May to review the Nellix two-year IDE results and the proposed new [instructions for use]," McDermott said. "Once we have alignment and a clear path to approval, we'll finalize and submit the Generation 1 PMA response to FDA, along with the request to restart enrolling patients in the CAP with the Generation 2 device."
He added, "Assuming these timelines hold true, this would position us for a potential Nellix PMA approval in 2Q18."
Sean Lavin, an analyst with BITG said the company could move past the recent issues in its product pipeline and be in a better position to compete with some of the larger players in EVAR.
"If the company can avoid further product issues, retain salespeople and physician relationships, and meet FDA timelines and move towards Nellix approval, and further develop the Ovation platform, the company may return to taking market share and regain investor trust," Lavin said.