Gardia Medical has announced that, according to the independent Clinical Events Committee (CEC), the company has successfully met the primary endpoint in its WISE-LE study.
The WISE-LE study’s objective is to demonstrate the safety and performance of the Wirion EPS in subjects undergoing lower extremity atherectomy for the treatment of peripheral artery disease (PAD). The primary investigator of the Study is Bill Gray from Lankenau Heart Institute in Philadelphia, USA.
According to the IDE-approved study protocol, the primary endpoint for the WISE-LE performance-goal study is freedom from major adverse events (MAEs) to 30 days post-procedure. The performance goal was based on Covidien’s DEFINITIVE LE and DEFINITIVE Ca++ trials. Currently, Covidien’s SpiderFX in the only embolic protection system cleared for the lower extremity indication in the USA.
The study protocol specified enrolment of 153 patients with the primary endpoint successfully met if 18 (12%) or fewer MAEs occurred according to CEC adjudication. An interim analysis was performed at 100 patients and the study was stopped for success at interim given the single MAE versus the nine (9%) allowed for success.
Gardia is expecting to receive an atherectomy independent labelling that will cover use with all atherectomy devices. The SpiderFX, the only FDA-cleared EPD for the lower extremity indication is limited for use with a specific atherectomy device.
Asaf Alperovitz, Gardia’s chief executive officer, said, “The CEC adjudication of only one non-device-related MAE, versus nine events which were allowed per protocol, is a major step for Gardia in the process towards FDA clearance for the lower extremities indication.”
“Gardia’s Wirion EPD is currently FDA-cleared for use during carotid artery stenting and has been used in more than 1,000 clinical procedures. The anticipated clearance of the lower extremities indication will position Wirion as the only protection solution approved for use with all FDA-cleared atherectomy devices. This will provide the physician with the most efficient and safe treatment solution for PAD patients who undergo atherectomy.”
Alperovitz added, “We strongly believe that the combination of Gardia’s advanced proprietary guide-wire independent technology, its strong clinical data in both the carotid and lower extremity indications, and the unique lower extremity broad labelling, differentiate the Wirion EPD from other embolic protection devices in the market and positions it as the leading protection solution.”