symphonX™ clinical outcomes

symphonX™ clinical data summary

Following a total number of five (5) acute pre-clinical in-vivo studies in a porcine model between March 2012 and September 2013, six (6) prospective clinical investigations have been conducted at the Hospital Italiano de Mendoza, Argentina to demonstrate the clinical performance of symphonX™:


Study objectives
First-in-Man: Lap-chole’s Evaluate FMX314 safety & feasibility for the treatment of cholelithiasis.

Date
December 2013

Reference (# of patients)
Broderick et al. Surg. Endosc 2014 (n=6)

Key points
•    No intra-operative complications
•    Umbilical incision length did not exceed 15 mm in any case
•    No adverse events, including umbilical hernia at 1 year follow-up


Study objectives
Phase II: Lap-chole’s Evaluate safety & assess effectiveness in a larger collective.

Date
December 2014

Reference (# of patients)
Berducci et al. Surg. Endosc 2015 (n=20)

Key points
•    No intra-operative complications
•    High, 89% procedural success rate despite complex cases
•    No adverse events at 5 months follow-up
•    Single-port lap-chole through a 15-mm trocar with the FMX314 platform is feasible, safe & reproducible in a larger patient population


Study objectives
Phase II – extended: Lap-chole’s Final design confirmation study.

Date
May 2015

Reference (# of patients)
N/A (n=4)

Key points
•    No intra-operative complications
•    Excellent cosmetic results


Study objectives
Phase I: Inguinal hernia repair Evaluate FMX314 safety & efficacy for the treatment of inguinal hernia.

Date
November 2015

Reference (# of patients)
To be submitted (n=4)

Key points
•    No intraoperative complications
•    75% procedural success rate (1 conversion due to difficult anatomy)
•    No adverse events, including recurrence and umbilical hernia at 6 months follow-up
•    Exceptional cosmetic results


Study objectives
Phase I: Tubal sterilization Evaluate FMX314 safety & efficacy for performing tubal sterilization. 

Date
May 2016 

Reference (# of patients)
N/A (n=3)

Key points
•    No intra-operative complications
•    100% procedural success rate
•    Average OR time: 35 minutes
•    Single-port laparoscopic tubal sterilization through a 15-mm trocar with the FMX314 platform is feasible, safe & reproducible


Study objectives
Phase I – extended: Inguinal hernia repair, feasibility study with shorter instruments.

Date
May 2016 & March 2017

Reference (# of patients)
N/A (n=3 & n=2)

Key points
•    No intra-operative complications
•    Single-port laparoscopic inguinal hernia repair through a 15-mm trocar with the FMX314 platform is feasible, safe & reproducible


References

Publications

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 – 1256

Presentations

Karl-Hermann Fuchs, MD, Transanal Assisted Colon Resection in Benign Disease, American Society For Gastrointestinal Endoscopy (ASGE) NOSCAR Summit in Downers Grove, IL, July 15, 2017

Hans F. Fuchs, MD, Transanal Colon Resection (TaCR) Using a symphonX™ Based Triangulating Surgical Platform: Initial Experience and Technical Details, Amazing Technology Session, 25th International Congress of the European Association for Endoscopic Surgery (EAES), Frankfurt am Main, Germany, June 14, 2017

Hans F. Fuchs, MD, Transanal Surgery Using The Novel Triangulating FMX314 Surgical Platform: Initial Experience and Technical Details, Emerging Technology Session, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting 2016, Boston, MA, March 18, 2016

Hans F. Fuchs, MD, Phase II clinical experience and long-term follow-up using the next generation single incision platform FMX314, Emerging Technology Session, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting 2015, Nashville, TN, April 17, 2015

Santiago Horgan, MD, Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15mm trocar: initial experience and technical details, Emerging Technology Session, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting 2014, Salt Lake City, UT, April 4, 2014


Note: FMX314 is the engineering code name for symphonX™ used during the pre-commercial phase.

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