February 19, 2018 3:47 PM ET

Healthcare Equipment and Supplies

Company Overview of Gardia Medical Ltd.

Company Overview

Gardia Medical Ltd. develops and sells catheter-based delivery systems that integrate with the workflow of stenting and cardiovascular intervention procedures. It offers embolic protection device, a wire-independent distal filtration system that reduces the incidence of embolic complications during stenting procedures, such as carotid and SVG angioplasty. The company’s deliver, lock, and deploy technology enables in-situ locking of cardiovascular devices, as well as addresses various applications in the field of interventional cardiology, including renal, PAD, and coronary stenting. It serves cardiologists in the United States. Gardia Medical Ltd. was founded in 2006 and is based in Caesarea...

13 Granit Street

North Industrial Park

Caesarea,  38900

Israel

Founded in 2006

Phone:

972 4 627 7994

Fax:

972 4 627 7995

Key Executives for Gardia Medical Ltd.

Chief Executive Officer
Age: 56
Founder and Chief Medical Consultant
Founder and Chief Technology Officer
General Manager
Vice President of Regulatory and Clinical Affairs
Compensation as of Fiscal Year 2017.

Gardia Medical Ltd. Key Developments

Gardia Medical Demonstrates Enhanced Safety in Lower Extremity Interventions

Gardia Medical 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. 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.

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