Contego Medical has enrolled the first subject in the PERFORMANCE III study, which is designed to further assess the effectiveness and safety of the Neuroguard IEPDirect System.
This multicentre and prospective trial is a follow-on to the fully enrolled PERFORMANCE II study of the carotid stent system.
The PERFORMANCE II trial has been conducted to assess the same stent placed through percutaneous transfemoral or transradial access.
Both trials are being carried out under an investigational device exemption (IDE) through the US Food and Drug Administration (FDA).
Both the Neuroguard IEP and Neuroguard IEP Direct Systems utilise the company’s IEP (integrated embolic protection) technology, which comes with a micro-filter integrated into the delivery catheter.
The micro-filter helps capture the micro-emboli, enabling physicians to better treat patients.
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The Neuroguard IEP Direct System features a new single-access-point blood flow reversal system that facilitates direct transcarotid access.
For minimising catheter exchanges and enhancing treatment efficiency, the Neuroguard system is designed as a three-in-one catheter with a stent, balloon and micro-filter.
In addition, the device leverages FlexRingstent technology, offering properties of both open and closed cell stents.
Contego Medical CEO Dr Ravish Sachar said: “At Contego, we’re driven to improve patient outcomes and will continue to collect robust clinical data to build upon the unprecedented stroke protection results already demonstrated with our IEP platform technology in the PALADIN and PERFORMANCE I studies.”
The company’s product portfolio includes the FDA-approved PaladinIEP carotid PTA balloon and filter system and the Vanguard IEPperipheral balloon angioplasty and filter system, as well as Excipio SV and LV thrombectomy devices.