InspireMD’s CGuard embolic prevention system has posted positive results in the PARADIGM study, led by principal investigator Piotr Musialek, as reported at the EuroPCR 2015 meeting (19–22 May, Paris, France).
PARADIGM, a prospective evaluation of all-comer percutaneous carotid revascularisation in symptomatic and increased-risk asymptomatic carotid artery stenosis using CGuard mesh-covered embolic prevention stent system, indicated that the CGuard system is appropriate for use in an all-comer carotid revascularisation population and is associated with favourable angiographic and clinical outcomes.
Musialek, commented, “Our experience with CGuard continues to be very positive. Evidence shows the device’s applicability for use in an all-comer population with no major adverse cardiac or neurological events (MACNE) during the procedure and at 30 days. We were also pleased with CGuard’s anti-embolic performance as well as its flexibility. Impressively, we had a procedure success rate of 100%.”
During his clinical presentation from the 71 CGuard procedures in unselected all-comer patients in the PARADIGM evaluation, Musialek summarised:
- Stent system success and procedure success rate were 100%
- Periprocedural complications were 0%, and remained so at 30 days
- No MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.
Musialek stated, “The system is unique in that it combines the most closed of the closed cell designs with the most open of the open cell designs,” and concluded, “Our experience indicates routine use of CGuard, which we believe presents a significant technological and clinical advancement, may form a new paradigm in carotid revascularisation.”