Three studies show that the FLEX Vessel Prep System safely and effectively modifies obstructive plaque to facilitate definitive therapies
MINNEAPOLIS , Jan. 28, 2021 / PRNewswire / – VentureMed Group, Inc. (VentureMed), a privately held innovative medical technology company, today announced that the results of three studies examining the use of the FLEX Vessel Prep (VP) system will be held during the virtual Leipzig Interventional Course (LINC) 2021, which will take place from 25. The event took place through January 29th, was presented and is now available on demand. VentureMed develops and markets innovative endovascular devices that meet the unmet need in the treatment of peripheral arterial disease (PAD) and stenosis of arteriovenous (AV) fistulas and grafts. The FLEX VP System is designed to modify plaque and prepare vessels with complex femoropopliteal arterial disease, including in-stent restenotic (ISR) lesions, prior to definitive therapy.
“Both individually and as a whole provide these three studies convincing results,” said J. Robert Paulson, Jr. , President and Chief Executive Officer of VentureMed . “The data show that the elongated circumferential micro sections of the FLEX Vessel Prep system, Safely and consistently modify plaque to improve vascular compliance and increase lumen gain with minimal trauma to the vessel, which can reduce the need for a stent and facilitate drug delivery into the vessel wall. The FLEX Vessel Prep System enables clinicians to do this To modify plaque and prepare diseased vessels of any length for optimal results with revascularization therapy. “
The following are summaries of the three studies that were presented at LINC 2021, an event with specialist presentations from leading interventional centers:
12-month results of the Micro-Incision Vessel Prep System show benefits in superficial femoral and popliteal arteries in acute and long-term cases
(Dr. Thomas Zeller , Ph.D., University Heart Center Freiburg – Bad Krozingen, Germany; Dr. Daniel Périard , et al., HFR-Hôpital Cantonal Friborg, Switzerland)
This single-center study examined the effect of vascular preparation with FLEX VP longitudinal, depth-controlled microincisions prior to drug eluting balloon angioplasty (DCB) or percutaneous transluminal angioplasty (PTA) therapy, both acute and after 6 and 12 months.
Results of the study:
- 63 patients with moderately to severely symptomatic femoropopliteal PAD with lesions averaging approximately 200 mm in length were treated with the FLEX VP to create circumferential microincisions of controlled depth before definitive DCB (paclitaxel) or PTA therapy was applied.
- The freedom from target lesion revascularizations (FTLR) at 6 and 12 months was 98.5% and 93.7%, respectively, with a low provisional stent rate of only 16.9%.
Patterns and number of dissections with atherectomy versus FLEX VP: an IVUS assessment (Dr. Nicolas W. Shammas , MS, et al., Genesis Health System, Davenport, Iowa , United States )
This comparative, prospective, single-center study was based on published data showing that dissection, rather than plaque compression, opens the lumen of occluded vessels after PTA. Published clinical data have also shown that severe NHLBI-classified dissections (Type C and above) and dissections involving the adventitia are likely to be associated with poorer results after definitive PTA therapy. This study examined the differences in dissection between atherectomy and the FLEX VP System in femoropopliteal arteries and included de novo and restenotic lesions using intravascular ultrasound.
Results of the study:
- For lesions of comparable treatment length and the presence of calcium, there was a pattern of significantly fewer and less severe dissections after FLEX VP vessel dissection compared to atherectomy.
- There were no differences in the extent of the new dissections after definitive PTA therapy was performed.
- These data suggest that the FLEX VP vascular preparation may be less traumatic than the atherectomy.
Lesion modification with a micro-incision vessel preparation system improves balloon-based drug delivery in complex restenotic lesions in pigs
(Rami Tzafriri, Ph.D., et al., CBSET, Boston, Mass. USA)
This study investigated whether and how a vascular dissection system that provides microsections could improve the in vivo retention of paclitaxel (administered by a DCB) in a complex porcine ISR lesion model design. Optical coherence tomography (OCT) images of the base ISR confirmed barriers to delivery of DCB therapy. Animals were either (a) viewed by OCT and treated with a DCB and then viewed again, or (b) viewed by OCT and viewed again after microincisions were made with the FLEX VP System, treated with DCB, and then viewed again. The animals survived for 1, 15 or 30 days and the treated arteries were then processed to measure the retention of paclitaxel concentrations.
Results of the study:
- The OCT imaging of the ISRLs showed smooth stenotic surfaces, which represent a significant barrier to penetration, as evidenced by the remarkably low paclitaxel concentrations after 1 day in standard vessels (<0.9 ng / mL).
- OCT imaging of the lesions treated with the FLEX VP System showed atraumatic microincisions along the length and circumference of the vessels, without dissections, and improved tissue retention of paclitaxel compared to the vessels treated with DCB alone.
About endovascular interventions
Endovascular interventions are now widely recognized as the first treatment option for patients with symptomatic PAD. Relatively severe vascular tears or dissections are common in PTA interventions. The vascular injury is often repaired through the use of stents or small intraluminal scaffolds. Severe dissections and the use of peripheral stents are associated with an increased risk of restenosis (re-obstruction of the vessel), thrombosis, and stent fracture after the procedure.
DCB and drug-eluting stent (DES) therapies are designed to deliver drugs to the inner walls of vessels to reduce the risk of vessel reclosure. For effective endovascular drug delivery, the vessels must be primed to remove barriers to drug diffusion prior to the administration of definitive therapy. The FLEX VP System safely and effectively modifies obstructive plaque by creating circumferential, controlled, deep micro-cuts of any length to improve vessel conformity, increase lumen gain and facilitate the introduction of final therapies.
Information about VentureMed and the FLEX Vessel Prep System
VentureMed develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of peripheral arterial diseases and stenoses of arteriovenous fistulas and transplants. The FLEX Vessel Prep ™ (VP) System is designed to safely and predictably modify plaque by creating long, controlled microincisions along the length of complex lesions of varying morphology. The FLEX VP System has 510 (k) approval from the US Food and Drug Administration and is CE marked for marketing and sale in the European Union. More information is available at www.flexvesselprep.com .
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SOURCE VentureMed Group
