Contego Medical has announced the US Food and Drug Administration’s (FDA) premarket approval (PMA) of the Neuroguard IEP Direct system and 510(k) clearance of the Neuroguard IEP embolic protection system (EPS). A company press release notes that, together, these systems provide dual-neuroprotection through both flow reversal and an integrated embolic protection (IEP) filter via direct transcarotid access, establishing a new approach category to carotid revascularisation—transcarotid artery revascularisation (TCAR)-IEP.
“Although TCAR with flow reversal alone has demonstrated low stroke rates, transcranial Doppler studies have shown that flow to the brain is not always reversed, thereby allowing microemboli to still reach the brain in some patients,” said Sean Lyden (Cleveland Clinic, Cleveland, USA), co-national principal investigator of the PERFORMANCE III investigational device exemption (IDE) study. “Given the uncertainty in complete flow reversal, this system combines flow reversal with an integrated filter to provide additional protection during the highest-risk phases of stenting and post-dilation.”
Contego shares that the PERFORMANCE III pivotal study of TCAR-IEP reported “unprecedented” 30-day outcomes with a 0% stroke rate in the intention-to-treat population and zero myocardial infarctions, zero cranial nerve injuries, zero neurological deaths, and zero stent thromboses. The primary endpoint, the 30-day rate of major adverse events, was 0.69% in the intention-to-treat population and 0% in the per-protocol population.
The company details that the Neuroguard IEP three-in-one stent delivery system integrates the stent, balloon, and 40-micron distal filter all in one device, reducing catheter exchanges and enhancing procedural efficiency. Furthermore, its closed-cell stent incorporates FlexRing technology, which is designed to optimise radial strength and flexibility.
Contego adds that the Neuroguard IEP EPS combines a purpose-built direct-access sheath with a flexible, pre-formed curve and a gravity-assisted flow reversal system, enabling streamlined transcarotid access without the need for venous access.
The Neuroguard IEP three-in-one system was previously studied for transfemoral and transradial carotid stenting in the PERFORMANCE I and PERFORMANCE II studies. It received FDA PMA approval in October 2024 and is commercially distributed by Medtronic.
