iDissection Classification Study Will Evaluate Dissection Rate of VentureMed's Flex Dynamic Scoring Catheter
November 14, 2018—VentureMed Group, Inc. recently announced the initiation of a new study to determine if the company's Flex dynamic scoring catheter reduces dissections and the need for bailout stents in peripheral arteries. The study entitled "Arterial Dissections Following Flex Scoring and Adjunctive Balloon Angioplasty: Intravascular Ultrasound Assessment and Correlation with Angiographic Findings” will utilize intravascular ultrasound (IVUS) to identify the health of the vessel after treatment.
Using IVUS, the study will evaluate the dissection rates of 15 patients after treatment of femoropopliteal de novo or no-stent restenosis by the Flex dynamic scoring catheter and plain old balloon angioplasty.
According to the company, the Flex catheter creates long parallel linear scores in all plaque morphologies to prepare an ideal vessel environment to facilitate angioplasty. Its dynamic technique safely scores difficult, diseased vessels, providing vessel compliance and acute lumen gain. The Flex device is cleared for sale in the United States and has CE Mark approval for sales in Europe.
The study's principal investigator is Nicolas W. Shammas, MD, Founder and Director of the Midwest Cardiovascular Research Foundation in Davenport, Iowa.
VascuMed noted that this is the second iDissection study performed by Dr. Shammas. The first study revealed that, after atherectomy in the peripheral arteries, significant dissections are more visible by a ratio of 6:1 when using IVUS in comparison to the typical angiogram. This suggests that the presence and severity of dissection after atherectomy may have been underestimated, especially for deeper dissections which are associated with recurrent restenosis, recoil, and possibly acute closure.
In the company's announcement, Dr. Shammas commented, “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.”