SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has received CE Mark approval in Europe for the Kiva™ Vertebral Compression Fracture (VCF) Treatment System. Initial clinical cases in Europe using the Kiva System have been successfully performed and the company is preparing for the commercial launch of the product throughout the region.
The Kiva System addresses unmet needs of spine physicians who treat painful VCFs due to osteoporosis, trauma, and cancer. The Kiva System incorporates Benvenue Medical’s proprietary, flexible spinal implant technology. The implant, which is manufactured from PEEK, is introduced using a percutaneous, over-the-wire technique. It reduces and stabilizes the fracture and is designed to provide containment during delivery of PMMA bone cement.
In over one year of clinical use, the Kiva System has provided VCF patients with immediate pain relief and consistent functional improvement, while requiring significantly less bone cement than is customarily used in kyphoplasty and vertebroplasty procedures.