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FLEX CLINICALS

Explore

FLEX CLINICALS

AV Clinical Data

AVAFLEX Prospective Observational Study1

FLEX Prior to Lutonix DCB – Compared with Lutenix IDE Results4 Target Lesion Patency
  1. Dialysis Access Institute, John Ross, MD, Orangeburg, SC (enrolling site in Lutonix DCB IDE study)
  2. Treated cephalic arch stenoses in 53% of enrolled patients
  3. Excluded patients with residual stenosis ≥30% following PTA to open the stenosis (e.g., vessel prep); treated cephalic arch stenoses in 19% of enrolled patients
  4. Ross J, Does Vessel Prep Make a Difference? Presented during CIDA 2019; San Diego, CA.

PAD Clinical Data

Consistent Outcomes In Long Complex PAD Lesions

POBA or DCB Dilatation Post-FLEX
1Patients also enrolled in the Intact Vascular Tack Optimized Balloon Angioplasty (TOBA) study
2Subset analysis
3Initial 255 patients of Post-Market Surveillance Study
4N = 252
5N = 532
6Oriowo, et.al, 2019 Int’l Symp. on Endovascular Therapy, Hollywood, FL, Jan. 26-29
7Manuscript submitted to/under review by Journal of Endovascular Therapy, Mar’21
8J Invasive Cardiol, 2019: 31(5): 121-126
9J Endovascular Therapy 2019, Vol. 26(3) 333-341
10Data on file at VentureMed

Summary:

  • Used in any length lesion across varying plaque morphologies

  • Post-FLEX balloon opening pressures ⁓4 atm

  • Post-FLEX acute luminal gain ⁓25% vessel prep prior to therapy

  • No reported perforations or embolizations

VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts.

VentureMed Group, Inc. is a member of Medical Alley

VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts.

VentureMed Group, Inc. is a member of Medical Alley