Crosstrees Medical has completed patient enrollment for the company sponsored pivotal IDE study, Clinical Evaluation of the Crosstrees PVA Pod System in Symptomatic Adult Patients with Acute Vertebral Body Compression Fractures at T4-L5.
Devices using Crosstrees Pod technology feature a polymer material to control the delivery of a specific volume and geometry of PMMA bone cement to the vertebral fracture site.
Crosstrees’ research staff developed the technology to address the need for vertebral fracture repair devices designed to reduce risk of complications in vertebral augmentation, such as nerve root compression, pulmonary embolism, and arterial embolism.
Crosstrees Medical president and CEO Robert Scribner said the company appreciates the efforts of its physician investigators and the research staff in enrollment of patients to the IDE study.
"We are pleased to reach this milestone, and look forward to completion of study follow up and presentation of results to the US Food and Drug Administration (FDA), physicians, and patients," Scribner said.
This IDE clinical study is being conducted in support of a future 510(k) market clearance submission to the FDA.
Privately held and funded by Ascent Biomedical Ventures, Rho Ventures and associated parties, Crosstrees Medical delivers surgical techniques and procedure outcomes for vertebral fractures.