Three Studies Evaluate VentureMed’s Flex Vessel Prep System

January 27, 2021—VentureMed Group, Inc. announced that data from three studies evaluating the use of the company’s Flex VP system were presented during LINC 2021, the Leipzig Interventional Course held as a virtual event January 25-29.

VentureMed’s Flex VP system is designed to modify plaque and prepare vessels with complex femoropopliteal arterial disease, including in-stent restenotic (ISR) lesions before delivery of the definitive therapy to treat peripheral artery disease (PAD). The device has received FDA 510(k) clearance in the United States and CE Mark approval in Europe.

The company provided the following summaries of the three studies presented at LINC 2021.

First, 12-month results from a single-center study assessed the impact of vessel preparation with Flex VP’s longitudinal, controlled-depth, microincisions before drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA) therapy in superficial femoral and popliteal arteries. The investigators evaluated the device’s outcomes acutely and at 6 and 12 months. The study was conducted by Thomas Zeller, MD, of the University Heart Center Freiburg in Bad Krozingen, Germany, and Daniel Périard, MD et al from HFR-Hôpital Cantonal in Fribourg, Switzerland.

In the study, 63 patients with moderate-to-severe symptomatic femoropopliteal PAD, with lesions averaging approximately 200 mm in length, were treated with the Flex VP to create circumferential, controlled-depth microincisions prior to delivery of the definitive DCB (paclitaxel) or PTA therapy. The freedom from target lesion revascularization at 6 and 12 months was 98.5% and 93.7%, respectively, with a low provisional stent rate of 16.9%.

Next, findings were presented from an intravenous ultrasound assessment of the differences in patterns and number of dissections with atherectomy compared with the Flex VP in femoropopliteal arteries, including de novo and restenotic lesions. Nicolas W. Shammas, MD, et al performed the study at Genesis Health System in Davenport, Iowa.

The single-center, comparative, prospective study was based on published data demonstrating that dissection, not plaque compression, is what opens the lumen of obstructed vessels post-PTA. Additionally, published clinical data has demonstrated that severe dissections per National Heart, Lung, and Blood Institute classifications (type C and higher) and dissections involving the adventitia are likely to be associated with worse outcomes after definitive PTA therapy.

Dr. Shammas and colleagues found that in lesions with comparable treatment lengths and presence of calcium, there was a pattern of significantly fewer and less severe dissections after Flex VP vessel preparation as compared to atherectomy. There were no differences in the extent of new dissections after delivery of the definitive PTA therapy. This data suggests that FLEX VP may be less traumatic as vessel preparation, noted the company's summary.

Finally, an animal study by Rami Tzafriri, PhD, et al from CBSET in Boston, Massachusetts, concluded that lesion modification with the Flex VP system enhances balloon-based drug delivery in complex porcine restenotic lesions.

The study examined if and how the device could enhance in vivo paclitaxel retention in a complex porcine ISR lesion model design. Optical coherence tomography (OCT) images of the baseline ISR images confirmed barriers to delivery of DCB therapy. The animals were either (1) imaged by OCT, treated with a DCB, and then reimaged; or (2) imaged by OCT, reimaged after microincisions were delivered by the Flex VP system, treated with DCB, and then reimaged again. The animals were survived to 1, 15, or 30 days and the treated arteries then were processed to measure retention of paclitaxel concentrations.

The investigators reported that OCT imaging of ISR lesions revealed smooth stenotic surfaces posing significant barriers to penetration as evidenced by remarkably low paclitaxel concentrations at 1 day in standard vessels (< 0.9 ng/mL). By contrast, OCT imaging of the lesions treated with the Flex VP system demonstrated atraumatic microincisions along the length and circumference of the vessels, with no dissections and enhanced tissue retention of paclitaxel as compared to the vessels treated with DCB alone.