W.L. Gore & Associates yesterday released 1-year data from a Japanese study of its Viabahn stent graft, touting a nearly 90% primary patency rate at 12 months.
Data comes from a 103-patient single-arm study which enrolled a “challenging patient population” with lesions greater than 10cm, Newark, Del.-based Gore said.
“Eighty-eight percent is an extremely high primary patency for these long complex lesions with an average length of 22 cm, especially given the scrutiny of the study design: a prospective, multicenter IDE clinical study that was core lab adjudicated and reviewed by the Japanese regulatory authority. The Gore Viabahn endoprosthesis, for the first time in endovascular history, may replace bypass surgery for femoro-popliteal disease,” Japan IDE clinical study principal investigator Dr. Takao Ohki said in prepared remarks.
Primary patency in all lesions was reported to be 88% at 12 months, with lesions less than or equal to 20cm reporting a 93% primary patency. Results also indicated a 10)% limb salvage with no cases of acute limb ischemia.
“The Gore Viabahn endoprosthesis has an extremely strong, growing body of clinical data in this category of complex SFA lesions. The Gore Japan IDE clinical study has once again proven that the Viabahn device effectively covers and seals off diseased tissue, enabling high patencies regardless of lesion length. This clinical study demonstrates that endoluminal bypass continues to be an essential component of a physician’s toolkit for treating complex SFA disease,” peripheral interventional biz unit leader Ray Swinney said in a prepared statement.
In June, Gore released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months.
The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA alone for treating challenging AV access cases, both in terms of primary patency and number of interventions during the study period.
Results from the study were published in the Journal of Vascular Surgery, Gore said.
Data from the study also indicated a 47% improvement in target lesion primary patency and a 48% improvement in circuit primary patency when compared against PTA alone at 6 months. In elbow placements, data indicated a 72% target lesion primary patency at 6 months and 83% access secondary patency at 24 months.
Median time to target lesion reintervention or graft abandonment with the Viabahn was reportedly 2 times that of PTA alone, and placement of the Viabahn led to 27% fewer interventions at the target lesion and in the dialysis access circuit over 2-years, when compared to PTA.