Referencias
1. Based on internal test report #RE00365735. Periscope II in vivo penetration/fixation competitive EBM test. In October 2021. 2. Based on VOC; Eichler Project Market Research Lieberman Research. March 22, 2013. 3. 16-emea-lap-progrip-technique-brochure-781498, Based on internal test report #0902CR123. June 2012. 4. Instructions for use of the ProGrip™ self-fixing laparoscopic mesh 5. Kolbe T, Hollinsky C, Walter I, Joachim A, Rülicke T. Influence of a new self-gripping hernia mesh on male fertility in a rat model. Surg Endosc. 2010;24(2):455-461. 6. Based on internal test report #TEX033a. October 2012. 7. Based on internal test report #98640. February 2012. 8. Based on internal test report #0902CR122. June 2012. 9. Based on internal project verification report #RE00010041, 10. Spacemaker™ Pro access and dissection system. December 2014. 11. Based on internal validation report #RE00013395, Spacemaker™ Pro access and dissection system. June 2015. 12. Spacemaker™ Pro [instructions for use]. Mansfield, Massachusetts: Medtronic;2014. 13. 11/2021- US-WC-2100106-[WF#5406475] 14. Demonstrated in a preclinical study sponsored by Covidien, carried out on pigs in May 2013 with 6 surgeons and aiming at validating the design of Symbotex™ composite mesh - Covidien internal report 0901CR252a (June 2013).15. Based on the results of the Covidien-sponsored preclinical study carried out on a porcine model to validate the design of Symbotex™ composite mesh - Covidien design validation report 0901CR249a (June 2013). 16. Definition of the Symbotex™ clinging effect observed during the design validation conducted by Covidien in a porcine model in May 2013 - Covidien internal memorandum 0901CR261a (July 2013). 17. Assessed in a preclinical study sponsored by Covidien, initiated in May 2013, using a porcine model to evaluate local tissue effects and tissue integration of Symbotex™ Composite mesh vs Parietex™ Optimized composite mesh after laparoscopic ventral repair - Namsa report No.163005 (October 2013). 18. Assessed in a preclinical study sponsored by Covidien, initiated in April 2013, using a rat caecal abrasion model and evaluating local tissue effects, tissue integration and minimizing tissue attachment performance of Symbotex™ composite mesh vs. Parietex™ Optimized composite mesh - Namsa report No.162750 (May 2013). 19. Evaluated in a preclinical study sponsored by Covidien, conducted in April 2013, and comparing local tissue effects and integration, collagen film degradation and tissue attachment performance of Symbotex™ composite mesh with Ventralight™* ST mesh and Physiomesh™* flexible composite mesh in a porcine model - Namsa report No.163905 (October 2013). 20. Comparison of the physical and mechanical properties of Symbotex™ composite mesh to those of Parietex™ optimized composite mesh through a bench study conducted by Covidien in July 2013 - Covidien internal report TEX043 (July 2013). 21. D. Weyhe, W. Cobb, D. Lomanto et al, Comparative analysis of the performance of a series of meshes based on weight and pore size in a novel mini-pig hernia model - EHS 2013 (SC130037). 22. Documented in the design verification report issued by Covidien in July 2013 - Covidien design verification report 0901CR247b (July 2013) 23. Based on internal surgeon labs for design validation #T2294CR208. Marketing VOC. Evaluation performed through users test and questionnaire in a simulated use environment using a porcine model (n=7). September 2016. 24. Based on internal preclinical report #T2294CR212, Design validation of Parietene™ DS composite mesh in surgeon labs: Feedback collected from seven independent surgeons in a simulated use environment using a porcine model. September 2016. 25. Based on internal test report #RAT207, Robotically assisted laparascopic ventral hernia repiar and Parietene™ DS composite mesh. November 2018. 26. Based on NAMSA study #197165. Thirteen week systemic toxicity and local tissue effects study in rats following subcutaneous implantation. August 2016. 27. Based on internal test report #T2294CR225, Comparison of nonabsorbable textile reinforcement properties of composite meshes. Descriptive comparison of values were obtained from benchtop testing of the textiles constitutive of the devices. Properties measured included: burst strength, resistance to plunger test, tear strength, suture pull-out strength (n=5 per group), and uniaxial breaking strength (n=6 per group). November 2016. 28. Based on NAMSA study #198929, Minimizing tissue attachment barrier performance, local tissue effects and tissue integration of Parietene™ DS composite mesh in a rat cecal abrasion model: occurrence rates of cecal soft tissue attachment to the mesh through macroscopic observations in the rat (n=18 test articles vs. n=18 Ethiocon ProceedTM* Surgical Mesh; p<0.05). October 2016. 29. Based on NAMSA study #194092, Pilot in vivo study: Parietene™ DS composite mesh versus competitive product in intraperitoneal pig model. Based on macroscopic, histologic, and scanning electronic microscopic (SEM) observations at four weeks in a porcine intraperitoneal implantation model (B1:K6n=6). December 2016. 30. Based on NAMSA study #212466, Pilot in vivo study: Parietene™ DS composite mesh versus competitive product in intraperitoneal pig model. Based on macroscopic and histologic observations at 12 weeks in a porcine intraperitoneal implantation model (n=6). December 2016. 31. . Based on internal report #T2294CR179. Design validation of Parietene™ DS composite mesh compatibility with tacks. May 2016. 32. Based on internal report #T2294CR181, Design verification of mesh suture strength in warp and weft direction. June 2016. sus procedimientos de reparación de hernia. 33. Based on internally sponsored preclinical study report #0506-141814, Report 10 days and 4 weeks implantation study in a porcine model, March 2012, and report #0506-141814, Report 10 days and 4 weeks implantation study – amendment 1, June 2012. 34. Tollens T, Den Hondt M, Devroe K, et al. Retrospective analysis of umbilical, epigastric, and small incisional hernia repair using the Ventralex™* hernia patch. Hernia. 2011;15(5):531-540. 35. Muysoms FE, Bontinck J, Pletinckx P. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. 2011;15(4):463-468. 36. Berrevoet F, Van den Bossche B, de Baerdemaeker L, de Hemptinne B. Laparoscopia evaluation shows deficiencies in memory ring deployment during small ventral hernia repair. World J Surg. 2010;34(7):1710-1715. 37. Burger JW, Halm JA, Wiismuller AR, ten Raa S, Jeekel J. Evaluation of new prosthetic meshes for ventral hernia repair. Surg Endosc. 2006;20(8):1320-1325. 38. Based on internally sponsored preclinical study report #0506-140983, Evaluation of the local tissue effects and tissue attachment minimization of a Parietex™ composite ventral patch in a rat caecal abrasion model, January 2012, and internally sponsored preclinical study report #0506-140983, Evaluation of the local tissue effects and tissue attachment minimization of a Parietex™ composite ventral patch in a rat caecal abrasion model – amendment 1, February 2012. 39. 11/2021– US-WC-2100106–[WF#5406475] 40. Based on internal Force TriVerse™ device report obtained from Global Cognos (FY2011 to mid FY2020) and Business Objects (mid FY20). 41. as per internal test report #RE0068753, a quantitative comparison with conventional monopolar electrosurgery: monopolar "L" hooked monopolar drag force measurements. March 2017. 42. per internal test report #REQ0115057, monopolar performance of the Valleylab™ mode on the Valleylab™ FT10 energy platform. September 2017. 43. per internal memo #RE00105221, power equivalency memo for the Valleylab™ FX8 and FT10 power platforms (VLFX8GEN/VLFT10GEN). July 2017. 44. Based on internal test report #RE00329878 rev A, Marketing evaluation of surgeon experience using the Sonicision™ 7 cordless ultrasonic curved jaw dissector. April 14-15 and 20-22, 2021. 45. Ding, Z., Wable, G., Rane, A. Use of LigaSure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;25(1): 49-51. 46. Levy, B., Emery, L., Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147-151. 47. Targarona, et al. A prospective randomized comparison of conventional electrosurgery, biopolar computer-controlled electrosurgery and ultrasonic dissection. Operative Outcome and Cost analysis. Surgical Innovation. Dic. 2005;12(4):339-344. 48. Manouras, et al. Sutureless open low anterior resection with total mesorectal excision for rectal cancer with the use of the electrothermal bipolar vessel sealing system. 2007. Med Sci Monit; 13(5): CR224-230. 49. Tamussino, K., et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecologic Oncology. Feb. 2005; 96(2):320-322. 50. Leonardo, C., et al. Laparoscopic nephrectomy using LigaSure system: preliminary experience. Journal of Endourology. Oct. 2005;19(8):976-8. 51. Daskalopoulos, G., et al. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study. International Urology and Nephrology. 2004;36(2):181-185.52. Cronje, H.S., et al. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet. Dic. 2005;91(3):243-5. 53. Araki, Y., et al. Clipless hand-assisted laparoscopic total colectomy using LigaSure Atlas. Kurume Medical Journal. 2004;51(2):105-8. 54. Campagnacci, R., et al. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc. 8 feb. 2007.55. Takada et al. Comparative study of electrothermal bipolar vessel sealer and ultrasonic coagulating shears in laparoscopic colectomy. Surgical Endoscopy. 2005;19:226-228. 56. Demirturk, F., et al. Comparison of the use of electrothermal bipolar vessel sealer with harmonic scalpel in total laparoscopic hysterectomy. 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