Endologix (NSDQ:ELGX) said today that it’s halting the unrestricted sale of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol.
“We monitor the performance of the Nellix system through clinical trials, our complaint monitoring system, physician interaction and available publications,” CMO Dr. Matt Thompson said in prepared remarks. “Our independently adjudicated data from the EVAS1 IDE clinical trial indicates that the Nellix system has performed well when used consistent with the current indications. However, data from recent Nellix publications leave us concerned that outcomes are suboptimal when the system is used outside current instructions for use.”
To ensure compliance with the clinical protocol, all cases are to be pre-screened by a panel of doctors and supported by the Irvine, Calif.-based company’s clinical specialists. Endologix said it’s also voluntarily recalling all existing inventory.
“Ensuring patient safety and optimal clinical outcomes is our top priority, and the current level of off-label use of the Nellix system cannot continue if we are to protect and preserve the potential for transformative endovascular aneurysm sealing therapy,” added CEO John Onopchenko. “Taking these actions aligns with clinical practice standards, allows us to control off-label use and will help us ensure appropriate application of the therapy.”
The new policies align Endotronix with recent guidelines issued by the European Society for Vascular Surgery, the company said.
“When used as indicated, EVAS is associated with low rates of aneurysm sac growth, Type 2 endoleaks and all-cause mortality,” Onopchenko said. “Our actions are intended to preserve and advance this therapy. Clinical data drives our decision making and is our basis for competing in the marketplace. Limiting the use of the Nellix system to only those cases rigorously adjudicated by a review board and performed under clinical protocol will ensure that high integrity data is generated and will enable us to deliver on the promise of this potentially disruptive therapy.”