• InspireMD (Boston) a developer of embolic protection systems (EPS), reported that Professor Joachim Schofer at the Hamburg University Cardiovascular Center, will present the results of the CARotid Embolic protection using microNET (CARENET) trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference, in Washington, on Sept. 16.
The detailed findings from the CARENET trial, which completed enrollment last month, will be presented at the TCT 2014 Innovation Session: Late Breaking Early Human Clinical Studies at 4:20 pm ET under the title "Evaluation of a PET Mesh Covered Stent in Patients with Carotid Artery Disease: Results of the First in Man CARENET Trial."
CARENET is a multi-specialty trial – including interventional cardiologists, interventional radiologists and vascular surgeons – assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The trial evaluates data from traditional assessments carried out post-procedure and at 30 days to include MACE (death, stroke, myocardial infarction), and ipsilateral stroke (31 days to one year). In addition, DW-MRI diffusion weighted magnetic resonance imaging (DW-MRI) will be evaluated pre- and post-procedure and at 30 days, as well as ultrasound examination at 30 days and one year on every patient.
The CGuard carotid embolic protection system uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary embolic protection systems. The MicroNet technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet 'pore' is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.
• Venaxis (Castle Rock, Colorado), an in vitro diagnostic company focused on obtaining FDA clearance for and ommercializing its CE marked APPY1 test, a rapid, multi-analyte assay for aiding in identifying children, adolescent and young adult patients who are at low risk for appendicitis, provided updates on the progress of its APPY1 FDA submission, commercial and marketing progress and next-generation product development.
Venaxis reported previously that its FDA submission for the APPY1 Test had been filed with the FDA, and that the FDA had reviewed the submission and provided Venaxis with an Additional Information (AI) request. Under the FDA's submission issue meeting procedure, Venaxis also requested clarification from the FDA on certain of its feedback contained in the AI request. Today, Venaxis is reporting the current status of its FDA submission.
The FDA has clarified the scope of the additional data requested to complete the supplemental filing to the submission package. Venaxis is in the process of compiling these data, revising its submission to address the FDA feedback, and plans to fully comply with the FDA's AI request. Based on an initial analysis of the scope of work required to completely respond to FDA feedback, Venaxis anticipates submission of the supplemental filing in 4Q14 of this year.
The company also reported what it said are positive advances in commercial market development as well as the product development work on the next generation product, referred to internally as APPY2. The company said it has engaged SomaLogic to assist Venaxis in developing a biomarker panel for the APPY2 test.