Gardia Medical Will Seek Lower Extremity Indication for Wirion Embolic Protection System
September 6, 2017—Gardia Medical, an Israel-based company, announced that the company's WISE-LE study met its primary endpoint, according to the study's independent clinical events committee.
WISE-LE demonstrated the safety and performance of Gardia's Wirion embolic protection system (EPS) in patients undergoing lower extremity (LE) atherectomy for the treatment of peripheral arterial disease. The study's Primary Investigator is Bill Gray, MD, with Lankenau Heart Institute in Philadelphia, Pennsylvania.
The primary endpoint for the WISE-LE performance goal study is freedom from major adverse events (MAEs) to 30-days after procedure. The performance goal was based on the DEFINITIVE LE and DEFINITIVE Ca++ trials of the SpiderFX (Medtronic), which is the only EPS cleared for the LE indication in the United States, but is limited for use with a specific atherectomy device, noted Gardia.
The study protocol specified enrollment of 153 patients with the primary endpoint successfully met if 18 (12%) or less MAEs occurred according to the clinical events committee adjudication. An interim analysis was performed with 100 patients and the study was stopped for success at interim given the single MAE versus the nine (9%) allowed for success.
The Wirion EPS is indicated to protect from blood clots and emboli that occur during catheterization. The system's locking mechanism allows the physician to use any guidewire throughout the procedure and to place the filter in any location on the guidewire. The Wirion system's catheter allows for retrieval of the filter following the placement of the stent.
According to the company, the study was conducted under an investigational device exemption from the US Food and Drug Administration (FDA).
Based on these clinical results, Gardia plans to submit an application for FDA 510(K) clearance in the coming months to market the Wirion EPS with a label that covers use with all atherectomy devices (ie, orbital, rotational, directional, laser) in LE atherectomy.
The Wirion is currently cleared by the FDA for use during carotid artery stenting. It is also approved for marketing in Australia for the carotid indication. In Europe and in Israel, it is approved for use in all cardiovascular indications.