06.17.15
Implanet, a Bordeaux, France-based medical technology company specializing in vertebral and knee implants, has enrolled the first patient in a major multi-center clinical protocol designed to study the firm’s Jazz Band system in the treatment of instrumented thoracic and lumbar arthrodesis (osteo-degenerative bone pathologies).
Jazz is the company’s primary technology, which is designed to treat spinal pathologies requiring vertebral fusion surgery. It has 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) and the CE mark.
The company recently received expanded FDA clearance and CE mark for additional indications of its Jazz rods.
The study will be led by principal investigator H. Francis Farhadi, M.D., Ph.D., of Ohio State University. The study, titled “Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Jazz System,” will examine the Jazz Band as an adjunct to spinal fusion in adult scoliosis and adult degenerative surgeries.
“At Ohio State, we are always in search of innovative technologies to advance the treatment of complex spinal pathologies,” Fahadi said. “We are excited to have started the Jazz Band study and look forward to analyzing the potential clinical and economic benefits of sublaminar band technology in complex spinal fusions.”
Patient recruitment will continue, with additional centers joining the study in the second half of the year, company officials said.
Implanet, founded in 2007, established a U.S. office in Boston, Mass., in 2013. The company employs 45 people and had 2014 sales of 7 million euros (approximately $8.5 million).
Jazz is the company’s primary technology, which is designed to treat spinal pathologies requiring vertebral fusion surgery. It has 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) and the CE mark.
The company recently received expanded FDA clearance and CE mark for additional indications of its Jazz rods.
The study will be led by principal investigator H. Francis Farhadi, M.D., Ph.D., of Ohio State University. The study, titled “Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Jazz System,” will examine the Jazz Band as an adjunct to spinal fusion in adult scoliosis and adult degenerative surgeries.
“At Ohio State, we are always in search of innovative technologies to advance the treatment of complex spinal pathologies,” Fahadi said. “We are excited to have started the Jazz Band study and look forward to analyzing the potential clinical and economic benefits of sublaminar band technology in complex spinal fusions.”
Patient recruitment will continue, with additional centers joining the study in the second half of the year, company officials said.
Implanet, founded in 2007, established a U.S. office in Boston, Mass., in 2013. The company employs 45 people and had 2014 sales of 7 million euros (approximately $8.5 million).