VentureMed launches Flex scoring catheter study

Vascular focused device developer VentureMed said yesterday that it launched a new study of its Flex dynamic scoring catheter, exploring whether the device reduces dissections and the need for bailout stents in peripheral arteries. In the newly launched iDissection Classification study, investigators will use intravascular ultrasound to identify the health of vessels after treatment with the Flex system, the Toledo, Ohio-based company said. The trial is being led by Dr. Nicolas Shammas of Davenport, Iowa’s Midwest Cardiovascular Research Foundation, who led the previous iDissection study. In the previous study, researchers found that after atherectomy, significant dissections in the peripheral arteries were more visible at a ratio of 6 to 1 when using IVUS as compared to standard angiograms. “After the indicative results of the initial iDissection study, I am motivated to look for vessel prep devices that further reduce the need for provisional stenting. I am optimistic about the ability of the Flex Catheter to reduce the rate of high-grade dissections and looking forward to the evaluation,” principal investigator Dr. Shammas said in a prepared statement. VentureMed said that analyzing the presence and severity of dissection after atherectomy “may have been underestimated,” specifically for deeper dissections which the company said are associated with recurrent restenosis, recoil and possible acute closure. The study will evaluate the dissectio...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Featured Vascular venturemed Source Type: news