Endologix (NSDQ:ELGX) said today it received notice that the CE Mark approval for its AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately, after being put on hold in early December.
The Irvine, Calif.-based company also released 3-year post-market registry data on its Ovation system, designed to treat abdominal aortic aneurysms, touting a 99% rate of freedom from aneurysm-related mortality, migration, rupture and conversion.
The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company, and regulatory clearance of the device was suspended over reports of type III endoleaks associated with a previous-gen version of the device.
Weeks after receiving the suspended CE Mark, Endologix put a hold on shipments of the AFX system as it investigated manufacturing issues with the devices.
Endologix said the CE Mark was reinstated based on low rates of reported Type III endoleaks with its current generation products.
“We are pleased that AFX and AFX2 are once again available to physicians and patients in Europe. The quick reinstatement of the CE Mark is a testament to the strong commercial clinical results achieved with the current generations of the device. Additionally, during this process we received numerous letters and endorsements from physicians worldwide and we’d like to thank them for their support,” CEO John McDermott said in a press release.
Leerink Partner analyst Richard Newitter saw the reinstatement as a positive, but said that the competitive impact of the suspension was still uncertain.
“Although the resolution has been speedy (~1 month since the CE Mark was suspended in December, and we can’t recall another medical device losing/reinstating its CE Mark so quickly) we think the impact to revenue could linger for a while (i.e., potentially through 1H17 in our view). We think it could take a few weeks to restock product, and furthermore we believe it could also take some time for the sales force to address surgeon concerns and bring back potential defectors to competitive systems,” Newitter wrote in a letter to investors.
Endologix shares have soared with the news, up 8.1% to trade at $6.68 as of 1:33 p.m. EST.
The company presented 3-year data from the 501-patient Ovation European post market registry of its Ovation AAA device, reporting a 99% freedom from aneurysm-related mortality, a 99% freedom from migration, rupture and conversion and a 97% freedom from Type 1 and Type III endoleaks.
Data from the tail also indicated a 97% freedom from secondary interventions for occlussion and a 95% freedom from Type II endoleaks.
Results from the study was presented at the 2017 Leipzig International Course sympsoium in Leipzig, Germany.
“This study confirms the ability of the Ovation platform to successfully treat a broad array of patient anatomies with a high rate of treatment success and freedom from secondary intervention through mid-term follow-up. We are pleased to have revealed these impressive results at our scientific symposium this year,” study principal investigator Dr. Dierk Scheinert said in a prepared statement.
“The addition of these European results continue to validate the excellent clinical results and durability of the ultra-low profile Ovation platform, further confirming the recently announced 5-year Ovation IDE study results with real-world commercial data. We would like to thank Dr. Scheinert, Dr. Peeters, and all of the investigators for their participation in this important clinical study and congratulate them for their outstanding results,” CEO McDermott said in a prepared release.