Inovedis’ SINEFIX Implants for Rotator Cuff Repair Earn FDA Nod

Inovedis, a German startup offering solutions for optimized patient care and minimizing the complexity of surgical interventions, has received U.S. Food and Drug Administration (FDA) clearance for SINEFIX, a new implant system for rotator cuff tears.
 
SINEFIX allows refixation of rotator cuff tendon to bone with a simplified surgical technique optimized for minimally invasive surgery.
 
“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,” Stefan Welte, MD, shoulder surgeon and inventor of SINEFIX, told the press.
 
According to Inovedis, the new technique will provide effective mechanical reinforcement of the fixed tendon and stimulate the intrinsic healing potential. SINEFIX is a simple staple implant, which creates a flat and even contact of tendon and bone. It distributes shear stress uniformly, and doesn’t cause punctual pressure peaks, while maintaining blood circulation and supporting healing.
 
Implant insertion is a two-step technique. The base plate is positioned, and fixation points are driven into the bone with a hammer and the appropriate SINEFIX instruments. No preliminary work is necessary and the device can be implanted using arthroscopic techniques or open reconstruction. This simplified technique was engineered to reduce risk of complications due to surgical errors and shortens surgery time.
 
“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,” said Lukas Flöss, Inovedis founder and CEO.  “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.”