Benvenue Medical wins CE Mark approval for Kiva VCF treatment system

Benvenue Medical said that initial clinical cases in Europe using the Kiva system have been successfully performed. The company added that it is preparing for the commercial launch of the product throughout the region.

According to the company, the Kiva system addresses unmet needs of spine physicians who treat painful vertebral compression fractures (VCFs) due to osteoporosis, trauma and cancer. The Kiva system incorporates the company’s flexible spinal implant technology, said Benvenue Medical. The implant, which is manufactured from Peek, is introduced using a percutaneous over-the-wire technique. It reportedly reduces and stabilizes the fracture and is designed to provide containment during delivery of polymethylmethacrylate bone cement.

The first clinical cases in Europe using the Kiva System were recently performed by Dr. Stephan Becker at the Orthopedic Hospital Speising in Vienna, Austria.

Laurent Schaller, president and CEO of Benvenue Medical, said: The CE Mark is an important milestone for the company because it allows us to commercialize the Kiva system in some of the largest and fastest growing VCF markets in the world, and further validate the benefits delivered by the system through expanded clinical use.