Crosstrees Medical, Inc. Completes Enrollment of USA IDE Study for Percutaneous Vertebral Augmentation (PVA)
IDE Clinical Study Evaluates Safety and Efficacy of the Crosstrees® Pod System in Treatment of Osteoporotic Vertebral Compression Fractures
BOULDER, Colo.--(BUSINESS WIRE)--Crosstrees Medical, Inc. today announced that it has completed enrollment of 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. Following PMMA delivery, the construct is opened and removed from the vertebra, leaving only the PMMA filler material, without the need for an additional implanted device in the spine. Research staff at Crosstrees developed the technology to address the need for improved vertebral fracture repair devices designed to reduce risk of complications in vertebral augmentation, such as nerve root compression, pulmonary embolism, and arterial embolism as reported in the published literature.
"We appreciate the efforts of our physician Investigators and their research staff in enrollment of patients to the IDE study," said Robert Scribner, President & CEO of Crosstrees Medical, Inc. "We are pleased to reach this milestone, and look forward to completion of study follow up and presentation of results to the U.S. Food and Drug Administration (FDA), physicians, and patients."
This IDE clinical study is being conducted in support of a future 510(k) market clearance submission to the FDA. Details of the IDE study may be viewed at http://clinicaltrials.gov/ct2/show/NCT00933036?term=Crosstrees&rank=1. Estimates for the incidence of pathologic vertebral compression fractures in the USA by the National Osteoporosis Foundation exceed 700,000 annually. Crosstrees has developed a portfolio of issued patents in the United States, EU, China, and Taiwan, with additional applications pending for a broad portfolio of therapeutic devices and methods of use.
For more information visit: www.crosstreesmedical.com.
About Crosstrees Medical, Inc.:
Founded in 2003, Crosstrees Medical, Inc. is committed to the delivery of improved surgical techniques and procedure outcomes for vertebral fractures. The company is privately held and funded by Ascent Biomedical Ventures, Rho Ventures, and associated parties.
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Crosstrees Medical, Inc.
Robert M. Scribner, 720-880-5811
President & CEO