An FDA advisory panel declined to endorse the Ventura interatrial shunt system, a heart failure device developed by V-Wave, a Johnson & Johnson company, according to a Dec. 5 TCTMD report. Panel members cited a lack of demonstrated benefit and unresolved safety concerns.
The Ventura system was proposed for use in patients with NYHA Class III heart failure with reduced ejection fraction (left ventricular ejection fraction of 40% or less) who remain symptomatic despite guideline-directed medical therapy. The submission was based on subgroup findings from the RELIEVE-HF trial, which did not meet its primary endpoint.
Panelists voted 9-6 that the device is safe in the short term but unanimously rejected its efficacy and overall risk-benefit profile. Members expressed concern over the post hoc analyses used to justify the application, with one panelist describing the approach as “statistical gymnastics,” according to the report.
The vote is expected to delay market entry for the shunt system and raises questions about future adoption. Despite acknowledging the procedural safety of the implant, the panel said stronger evidence is needed to justify regulatory approval, the report said.
