Safe Orthopaedics Marks European Launch of New Fenestrated Screw Used for Osteoporosis

Safe Orthopaedics, based in Eragny-Sur-Oise, France, has launched a new fenestrated screw in Europe. Company officials reported the successful completion of the first six surgeries using the device on patients with osteoporosis.

“The first surgeries have been a success. The Safe Orthopaedics fenestrated screw is very easy to use and allows us to save substantial time while reducing the risks to the patient,” said Gianluca Maestretti, M.D., orthopedic surgeon at Fribourg cantonal hospital in Switzerland.
Having recently been granted CE marking, the Safe Orthopaedics fenestrated screw has lateral windows enabling cement to be injected into osteoporotic vertebra in order to strengthen the screw’s anchoring to the bone.

The technology is a combination of the fenestrated screw and its preassembled single-use instruments that, according to the company, eliminates the risk of cement leakage where the screw meets the instrument, resulting in improved patient safety. The dosage of cement directly used in a cannula in the screwdriver’s handle makes it easier for surgeons to use and therefore reduces operating time. In addition, the instruments preassembled on the implant reduce the cost of the procedure for hospitals.

Osteoporosis is characterized by a reduction in bone mass that makes bones more brittle. The aging population in developed countries is thus driving the growth of the fenestrated screw market across Europe.

“We are delighted with these first surgeries using our fenestrated screw combined with its preassembled single-use instruments. This new screw is perfectly in line with our strategy of expanding our product offer for spine surgery. Safe Orthopaedics is continuing to innovate in order to provide greater safety for patients, to improve operating conditions for surgeons and to reduce costs for hospitals,” said Dominique Petit, founder, chief technical officer and chief operations officer of Safe Orthopaedics.

Founded in 2010, Safe Orthopaedics develops sterile implants and associated single-use surgical instruments. The company’s CE-marked and U.S. Food and Drug Administration-approved SteriSpine kits are marketed throughout Europe and the United States. The company reports more than 1,000 procedures performed during the past 12 months using the kits.