Author: Eugene Cho, MD
FortiMedix received FDA approval for the symphonX™ (FMX314) Surgical Platform on August 26, 2016.
The symphonX™Â surgical platform provides a path of entry for laparoscopic instruments and camera through a single site and allows for triangulation similar to standard laparoscopy. The device fits through a standard 15-mm trocar and has 4 channels, enabling a surgeon to use two 5-mm instruments, a 5-mm camera and a 3-mm device. The device does not require inversion or hand crossing to achieve triangulation.
This platform system consists of an introducer and six instruments: a Maryland, Grasper, Clip Applier, Scissors, Hook-Knife and Suction-Irrigator. All instruments are disposable. The included instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures to allow for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating and suction-irrigation of tissues and vessels during laparoscopic procedures.
The safety and feasibility of the symphonX™Â surgical platform has been confirmed in animal, cadaver, and human studies. The first human study was a case series of 6 patients who underwent cholecystectomy for cholelithiasis in December 2013. The study displayed that use of the symphonX™Â surgical platform was safe, feasible, and reproducible. There were no intraoperative complications and no adverse events (Broderick et al. Surg. Endosc 2014). Subsequent Phase II trial with 20 patients displayed an 89% procedural success rate with no adverse events at 5 months post-procedure (Berducci et al. Surg. Endosc 2015). Phase I trials have shown safety and feasibility for inguinal hernia repair and for tubal ligation.
The FDA determined this device is substantially equivalent to 2 predicate devices: SPIDER™ Single Port Surgical Device (TransEnterix, K090902) and SPIDER™ Surgical Instruments (TransEnterix, K091697).
The symphonX™Â is approved for use in laparoscopic intraabdominal procedures. It cannot be used when laparoscopic surgery is contraindicated.
Berducci M, Fuchs HF, Omelanczuk P, Broderick RC, Harnsberger CR, Langert J, Nefa J, Jaureguiberry P, Gomez P, Miranda L, Jacobsen GR, Sandler BJ, Horgan S. Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314. Surgical Endoscopy, March 2016, Vol. 30, 3, pp. 953 – 960
Broderick RC, Omelanczuk P, Harnsberger CR, Fuchs HF, Berducci M, Nefa J, Nicolia J, Almadani M, Jacobsen GR, Sandler BJ, Horgan S. Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details. Surgical Endoscopy, May 23, 2015, Vol. 29, 5, pp. 1250 â 1256