Findings Presented That Show Luminal Gain With VentureMed's Flex VP System
June 4, 2019—VentureMed Group, Inc. announced that new data for the company's Flex VP vessel preparation system were presented at the 20th Annual New Cardiovascular Horizons (NCVH) annual conference held May 29–31 in New Orleans, Louisiana.
The Flex iDissection study used intravascular ultrasound (IVUS) to assess the reduction in the rate and severity of dissections in peripheral arteries when the Flex system was used before angioplasty.
The Comparative Review of the Flex VP system evaluated real-world data from the treatment of femoropopliteal lesions of differing lengths.
According to the company, the Flex VP system facilitates an environment for treating peripheral artery disease and arteriovenous fistulas and grafts by safely creating linear, parallel microincisions in plaque of any length to deliver acute lumen gain and vessel compliance. The Flex VP system received European CE Mark approval in 2015. In the United States, it received FDA 510(k) clearance in 2016.
As summarized by VentureMed, the Flex iDissection study was composed of 15 patients who were evaluated by angiogram and IVUS after treatment of femoropopliteal de novo or no-stent restenosis with the Flex VP system and percutaneous transluminal angioplasty (PTA). The patients had an average median baseline stenosis of 77% and an average lesion length of 64 ± 33 mm. Of these patients, 40% had moderate/severe calcified vessels (PACSS score ≥ 3), 40% were diabetic. Claudication was present in 73% of the patients.
Angiogram and IVUS images were obtained at baseline, posttreatment with the Flex VP system, and postadjunctive PTA to evaluate the presence and grade of dissections.
The company reported that the study showed significantly fewer new dissections as well as lower gradations in the circumference and depth patterns of new dissections after treatment with theFlex VP system and adjunctive PTA.
The majority of new dissections post-PTA after vessel preparation with the Flex VP system involved mostly the intima (78.4%) and were < 180° in circumference (81.1%). Vessel preparation involving only the layers superficial to the internal elastic lamina may prevent restenosis, noted VentureMed.
The study's lead investigator, Nicolas W. Shammas, MD, commented in the company's announcement, "Dissections are grossly underappreciated on angiogram when compared with IVUS. Percutaneous transluminal balloon angioplasty causes dissections and stretching of the vessel to restore blood flow. However, the severity and depth of the dissections can contribute to restenosis. This is a positive signal as these results showed a low rate of dissection after using the Flex VP system with the majority of those dissections being lesser in depth and circumference."
In the comparative review, the real-world data of 443 femoropopliteal cases were reported from 104 operators in 70 health systems treating lesions of varying lengths (≤ 8 or > 8 mm). The mean 28% improvement in luminal gain achieved by the Flex VP system alone was consistent regardless of lesion length. Low PTA balloon opening pressures (averaging 4.7 atm) suggest the Flex VP system positively improves vessel compliance.
Interventional cardiologist, Jason A. Yoho, MD, who presented the findings at NCVH, stated in the company's announcement, "[These] data highlight the importance of the unique Flex VP mechanism of action that provides acute luminal gain and improved vessel compliance to reduce PTA balloon opening pressures leading to meaningful clinical results. [These] real-world data on the use of the Flex VP system [are] clinically relevant and important as we continue to evaluate options that may help patients achieve better clinical outcomes."