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 dissection rates of 15 patients following treatment of femoropopliteal denovo or no-stent restenosis using the Flex system and plain old balloon angioplasty, the company said.
“VentureMed Group is honored to be working with such an esteemed interventionalist and outstanding laboratory. In over 400 registry case report forms, from multiple physicians that have reported on the performance of the Flex dynamic scoring catheter, we have seen low rates of minor dissections, less stents, and lower balloon inflation pressures required for lesion effacement. As we embark on this new adjudicated study, we are confident Dr. Shammas will experience similar results. We are anticipating improved outcomes that the Flex positively impacts results as a safe and effective means of vessel prep in this iDissection study, along with future studies,” chief science officer Dr. John Pigott said in a press release.
In August, VentureMed said that it raised $15 million in a Series B round.
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