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News Release - September 6, 2017
Gardia Medical Demonstrates Enhanced Safety in Lower Extremity InterventionsGardia met the primary end-point for the WISE-LE FDA study with an unprecedented safety profile
In the 100-patient interim analysis, only one event was adjudicated as a Major Adverse Event (MAE) versus the 9 events allowed based on the historical comparator (Covidien's DEFINITIVE LE and DEFINITIVE Ca++ trials)
Based on these strong clinical results, Gardia plans to submit a 510(K) in the coming months, for FDA clearance to market its WIRION™ EPS as the only device with a label that covers use with all atherectomy devices (orbital, rotational, directional, laser) in Lower Extremity (LE) atherectomy.
CAESAREA, Israel, Sept. 6, 2017 -- (Healthcare Sales & Marketing Network) -- Gardia Medical, an Israeli Medical Device Company focused on embolic protection solutions, announced that according to the independent Clinical Events Committee (CEC), Gardia successfully met the primary end-point 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 LE atherectomy for the treatment of Peripheral Arterial Disease (PAD). The Primary Investigator of the Study is Dr. Bill Gray from Lankenau Heart Institute in Philadelphia.
According to the IDE approved study protocol, the primary end-point for the WISE-LE performance-goal study is freedom from 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 LE indication in the US.
The study protocol specified enrollment of 153 patients with the primary end point successfully met if 18 (12.0%) or less 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 9 (9%) allowed for success.
Gardia is expecting to receive an Atherectomy Independent Labeling that will cover use with all atherectomy devices. The SpiderFX, the only FDA cleared EPD for the LE indication is limited for use with a specific atherectomy device.
Asaf Alperovitz, Gardia's CEO: "We are excited that Gardia successfully met the primary end-point in the WISE-LE clinical study based on the early interim data while demonstrating an enhanced safety profile. The CEC adjudication of only 1 non-device related major adverse event, versus 9 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 Gardia's 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 LE indications, and the unique LE broad labeling, differentiate the WIRION EPD from other Embolic Protection Devices in the market and positions it as the leading protection solution."
About the WIRION® system:
WIRION® is a unique Embolic Protection System, indicated to protect from blood clots and emboli occurring in the course of catheterization. The system has a proprietary locking mechanism, allowing the physician to use any guide wire throughout the procedure and to place the filter in any location on the guide wire. The flexibility of using the guidewire of choice and placing the filter anywhere along the guide-wire simplifies the procedure, increases is safety profile and makes it more effective – important advantages over other solutions on the market.
The WIRION® system also includes a unique catheter for easy, quick and safe retrieval of the filter following the placement of the stent.
The WIRION® system is approved for marketing in the US and in Australia for the Carotid indication. In Europe and in Israel, it is approved for use in all cardiovascular indications.
Source: Gardia Medical
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