Image courtesy of InspireMD
June 23, 2015 - InspireMD Inc. announced that its CGuard embolic prevention system reported positive results in the PARADIGM study at the EuroPCR conference, May 22 in Paris. The study was lead by principle investigator Prof. Piotr Musialek.
PARADIGM (an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization 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 revascularization population and is associated with an extremely favorable angiographic and clinical outcome.
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 percent."
During his clinical presentation from the 71 CGuard procedures in unselected all-comer patients in the PARADIGM evaluation, Prof. Musialek summarized:
- Stent system success and procedure success rate were 100 percent;
- Periprocedural complications were 0 percent, and remained at 0 percent at 30 days; and
- 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 revascularization."
For more information: www.inspiremd.com