Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed.
Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related.
In addition to new information as to the root cause of leaks, the May 2020 correction notice also contained information regarding the incidence of aneurysm related complications and the lack of long-term sequelae following underfilling of the polymer rings caused by a polymer leak.
The lifetime present rates of systemic clinical harms are tabulated below. These rates are based on voluntary complaint reporting and units sold, which may underestimate the true rate on a per-patient basis and contain less information than would be typical of an analysis from a clinical trial, as such some data are incomplete. The May 2020 analysis uses a different methodology than was previously used in the 2018 and 2020 correction notices, where the most severe systemic clinical harm was presented for each patient and, therefore, the number of clinical harms was equal to the number of patients.

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