The SINEFIX implant system introduces a simplified surgical technique specifically tailored for minimally invasive procedures, enabling efficient reattachment of the rotator cuff tendon to the bone
The SINEFIX implant system introduces simplified surgical technique specifically tailored for minimally invasive procedures. (Credit: Sasin Tipchai from Pixabay)
Inovedis has recently obtained clearance from the US Food and Drug Administration (FDA) for its latest implant system, SINEFIX, designed for the treatment of rotator cuff tears.
Every year, more than one million rotator cuff surgeries are performed in the US. Rotator cuff tears are a common cause of shoulder pain and disability, requiring surgical intervention to reattach the tendon to the upper arm bone (humerus).
The SINEFIX implant system introduces a simplified surgical technique specifically tailored for minimally invasive procedures, enabling efficient reattachment of the rotator cuff tendon to the bone.
This innovative approach aims to streamline the surgery, making it easier and quicker for surgeons to learn while significantly reducing both the time and cost associated with the procedure.
SINEFIX inventor Stefan Welte said: “Current clinical standards rely on anchoring the ruptured tendon onto its anatomical insertion zone, or ‘footprint,’ upon the humerus using a ‘knot and anchoring technique’.
“However, these techniques are complex, time-consuming, require an extensive range of instruments and are quite expensive. Moreover, they mainly focus on improving the mechanical fixation of the tendon-bone interface to the detriment of biological healing.”
Distinguished from traditional surgical methods, the novel technique offers dual benefits by providing effective mechanical reinforcement to the repaired tendon while also stimulating the patient’s innate healing capabilities. The SINEFIX implant, a straightforward staple design, facilitates a flat and uniform contact between the tendon and bone. By distributing shear stress evenly and avoiding localized pressure points, this implant ensures optimal blood circulation and promotes the healing process.
The implantation of the SINEFIX device involves a straightforward and easily graspable two-step technique: first, the base plate is positioned, followed by driving the fixation points into the bone using a hammer and the specialized SINEFIX instruments provided by Inovedis. This streamlined approach eliminates the need for preliminary preparation, allowing for implantation through either arthroscopic techniques or open reconstruction.
By minimising the complexity of the procedure, this simplified technique mitigates the risk of surgical errors and considerably reduces surgery time. Consequently, it not only contributes to improved patient outcomes but also yields substantial time and cost savings in clinical surgeries.
Inovedis founder and CEO Lukas Flöss said: “With FDA clearance we will now initiate a first mover application to generate real-world experience in the U.S. to evaluate the potential of the technology.
“We are looking forward to the launch of SINEFIX at the upcoming American Orthopaedic Society for Sports Medicine (AOSSM) annual meeting July 13-16th in Washington DC, followed by enrolling clinical sites into our limited market release to begin gathering experience around SINEFIX.”