FLEX vessel prep system data show key findings including luminal gain

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VentureMed Group’s FLEX

New data presented at the 20th annual new cardiovascular horizons (NCVH) conference (29–31 May, New Orleans, USA) show positive results for VentureMed Group’s FLEX VP system.

The FLEX iDissection study utilised intravascular ultrasound (IVUS) to assess the reduction in the rate and severity of dissections in peripheral arteries when the FLEX vessel prep system (VentureMed Group) was used prior to angioplasty.

Fifteen patients were evaluated by angiogram and IVUS following treatment of femoropopliteal de novo or no-stent restenosis with the FLEX VP system and percutaneous transluminal balloon angioplasty (PTA). The patients had an average median baseline percentage stenosis of 77%; an average lesion length of 64±33mm; 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, post-FLEX VP System, and post-adjunctive PTA to evaluate the presence and grade of dissections. There were significantly fewer new dissections, as well as lower gradations in the circumference and depth patterns of new dissections, post-FLEX VP system and adjunctive PTA.

The majority of new dissections post-PTA, following vessel preparation with the FLEX VP system, involved mostly the intima, the inner most layer of the vessel, (78.4%) and were <180° in circumference (81.1%). Vessel preparation involving only the layers superficial to the internal elastic lamina may prevent restenosis.

“Dissections are grossly under-appreciated on angiogram when compared with IVUS. PTA causes dissections and stretching of the vessel to restore blood flow. However, the severity and depth of the dissections can contribute to restenosis,” comments lead investigator Nicolas W Shammas, (Midwest Cardiovascular Research Foundation, Davenport, USA). “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.”

Also at NCVH, real-world data of 443 femoropopliteal cases reported from 104 operators in 70 health systems treating lesions of varying lengths (less than or equal to 8mm or greater than 8mm) were presented.

Speaking of this comparative review of the FLEX VP system in the treatment of femoropopliteal lesions of different lengths, Jason A Yoho (Heart and Vascular Institute of Texas, San Antonio, USA) says: “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. This real-world data on the use of the FLEX VP system is clinically relevant and important as we continue to evaluate options that may help patients achieve better clinical outcomes.”

The investigators found that 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 4.7atm) suggest the FLEX VP system positively improves vessel compliance. A press release states that the FLEX VP system creates an ideal environment for PTA of choice and was shown to safely and effectively facilitate PTA of femoropopliteal stenosis of differing lengths.

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