How FASB13 Impacts Your Hospital’s Purchasing Needs
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Michael W. DeWan is a Portfolio Manager for Respiratory & Monitoring Solutions at Medtronic. With more than 12 years in the Medical Device Industry, he develops financial and contractual strategies to help Integrated Delivery Networks ensure the best patient outcomes, across the care continuum. This is accomplished with monitoring solutions such as Nellcor™, Microstream™, Vital Sync™, INVOS™, Puritan Bennett™, BIS™, and McGrath™.
“It manages energy so you spend yours focused on the patient” Reference: Valleylab™ FT10 Energy Platform [Service Manual]. Boulder, CO: Medtronic 2015.
“Next generation electrosurgical precision” Reference: Based on internal test report # R0064443 Rev A, Ex-vivo Monopolar Procedural Flow Evaluation on the Valleylab™ FT10 Energy Platform; November 2014.
“Freedom of movement” Reference: Based on internal test report #2-108-10, Validation of Milwaukee USG1 marketing report surgeon evaluation of 5mm Cordless Laparoscopic Ultrasonic Shears. April 8 – May 6, 2010.
“Precise dissection and reliable seals from one device” Reference: Based on internal test report #RE00041188, Validation marketing claims: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine labs. October 2015 and February 2016.
“Benefits stick. Tissue doesn't. nonstick nano-coating makes LigaSure™ technology better than ever” References: When Comparing the LF4418 to the LF4318, the nonstick coating on the LigaSure Impact™ device jaws reduces sticking by 67%. Based on internal test report #RE00034755, LF4418 design verification report: benchtop testing using porcine abdominal aorta, mesentery, and renal arteries, with average (lbs.) sticking force. Feb. 24, 2016 and March 25, 2016.
When comparing the LF1837 to the LF1637, the nonstick coating on the LigaSure™ blunt tip device jaws reduces sticking by 41%. Based on internal test report #RE00062678, Benchtop tissue sticking comparison of the Ethicon™* G2, Voyant™* 5 mm Fusion, LigaSure™ LF1637, and LigaSure™ LF1837 devices conducted on porcine uterine tissue using the ForceTriad™ energy platform. Instances of tissue sticking to jaws measured over 110 seals per device. October 5, 2016.
1. Based on internal test report #RE00077194, Bag and device reliability memo. 2016.
2. Based on internal test report #RE00007964, ReliaCatch™ specimen retrieval bag summative validation. 2016.
3. Based on internal test report #RE00072916, ReliaCatch™ specimen retrieval bag 10 mm and 12 mm claims matrix benchmark data. Ethicon, Applied, Anchor, and Genicon are considered the major competitors and ReliaCatch™ device was tested appropriately against their specimen retrieval devices. For CATCH10, as compared with Applied Inzii™*, Anchor Tissue Retrieval System™*, Ethicon EndoPouch™*, Genicon GeniStrong™* and predicate Endo Catch™ Gold device. For CATCH12, as compared with Genicon GeniStrong™* 12 mm and Applied Inzii™* 12/15 mm. 2016.
4. Based on internal test report #RE00070348, Specimen retrieval devices: Specification development & justification. As compared to predicate Endo Catch™ Gold device. 2016.
† Based on internal sales data, FY01–FY20. 2019.
‡ Measured over a variety of tissue types and multiple seals per device.
§ Compared to normal systolic burst pressure
Ω Temperature measured using an IR camera and thermocouple temperature readings. (FT10 and ForceTriad™ Energy Platforms).
††Based on 17 papers published between 2008 and 2016 on colorectal, hysterectomy, and thyroidectomy procedures.
‡‡ Acute testing.
1. Based on Cognos and historical sales data, FY01–FY20. 2019.
2. Comparison of the Applied Medical Open Fusion device vs. LF4418 device in an acute porcine study. 2019.
3. Based on internal test report #RE00059404 Rev A, Market research – renal artery burst pressure comparison of LigaSure™ L-hook (LF56XX) versus Harmonic Ace™*+7 and Olympus Thunderbeat™* using the ForceTriad™ energy platform and Valleylab™ FT10 energy platform on porcine renal arteries. Aug. 16–18, 2016, Aug. 29–Sept. 1, 2016.
4. Based on internal test report # RE00091646, Benchtop testing: Thermal profile comparison using porcine mesentery with the Ethicon Enseal™* X1 large jaw vessel sealer vs. the LigaSure Impact™ device (LF4418) on the ForceTriad™ and Valleylab™ FT10 energy platforms. May 19, 2017.
5. Based on IMS data Q3 CY18, RF vessel sealer U.S. market share (excluding robotic RF vessel sealers). 2018.
6. Based on internal bench testing report #RE00337466 Comparison of the Renal Artery Seal Burst Pressure with the Ethicon Enseal® X1 Curved Jaw Tissue Sealer Device vs. the LigaSure™ LF18XX and LF19XX conducted on June 8-9, 2021.
7. Based on internal test report #RE00153868 rev B, Thermal profile comparison of the Harmonic Focus+™* shears, ThunderBeat™* open fine jaw, Voyant™* fine fusion, and LigaSure™ LF1212 vs. LigaSure™ LF2019 on the Valleylab™ FT10 and Valleylab™ LS10 energy platform and the 13 cm Sonicision™ curved jaw. Jan 2019.
1. Based on Covidien product verification report: "Autobipolar Evaluation - Valleylab™ FT10"; RE0064455 Feb 2015
2. Bench testing model used to evaluate sealing time, when compared to the ForceTriad™ energy platform. Based on Covidien memo: "LigaSure Data Sources for VLFT10 White Papers." September 2015 RE00025819 Rev A
3. Based on the Valleylab™ FT10 Service Manual: part number 1079477, REV 01/2015
4. Smarter: As compared to the ForceTriad™ energy platform. Based on the Valleylab™ FT10 Service Manual: part number 1079477, REV 01/2015
5. Simpler: As compared to the ForceTriad™ energy platform. Based on Covidien product validation report: "Product Validation of Valleylab™ FT10 Surgeon & Nurse Evaluation in Simulated Use" January - February, 2015; RE00005401
6. Based on Covidien ex-vivo monopolar report: "Verification - report - Ex-vivo Monopolar Procedural Flow Evaluation on the Valleylab™ FT10 Orion." November, 2014; R0064443 Rev A
1. Based on internal test report #RE00003687, Data collected during 17 procedures for product introduction. April–June 2017.
2. Roje Z, Racić G, Dogas Z, Pisac VP, Timms M. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blinded study. Coll Antropol. 2009;33(1):293–298.
3. Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–1594.
4. Based on internal test report #RE00073873 and #RE00079704, Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 2017.
5. Based on internal test report #RE00077022, Porcine testing. Jan. 9–10, 2017.
6. Based on internal test report #RE00011247, Benchtop testing comparing the BiZact™ tonsillectomy device with the E1551X Valleylab™ Hex-locking blade electrode. March 23, 2017.
7. Based on internal test report RE00015788 collected during Medtronic-sponsored tissue testing conducted on March 23, 2017
8. Wilson YL, Merer DM, Moscatello AL. Comparison of three common tonsillectomy techniques: a prospective randomized, double-blinded clinical study. Laryngoscope. 2009;119(1):162–170.
9. Jones DT, Kenna MA, Guidi J, Huang L, Johnston PR, Licameli GR. Comparison of postoperative pain in pediatric patients undergoing coblation tonsillectomy versus cautery tonsillectomy. Otolaryngol Head Neck Surg. 2011;144(6):972–977.
10. Based on internal test report #RE00015788, Tissue testing. March 23, 2017.
†Compared to the competitive closure device, suture passers, and hand sutures.
1. Based on internal validation report #RE00098009 Rev A, DoubleTime VersaOne™ fascial closure system Miami lab VOCreport: 13 out of 16 surgeons surveyed agreed. March 28, 2017.
Jaws Cool Faster. - Based on internal test report #RE00059406 Rev A, Market research - thermal profile comparison of LigaSure™ retractable L-hook (LF56XX) versus Harmonic Ace™*+7 and Olympus Thundebeat™* using the ForceTriad™ energy platform and Valleylab™ FT10 energy platform on porcine mesentery with 10 consecutive seal/cut cycles. Sept. 7, 2016.
Three Times Cooler - Based on internal test report #RE00059406 Rev A, Market research - thermal profile comparison of LigaSure™ retractable L-hook (LF56XX) versus Harmonic Ace™*+7 and Olympus Thundebeat™* using the ForceTriad™ energy platform and Valleylab™ FT10 energy platform on porcine mesentery with 10 consecutive seal/cut cycles. Sept. 7, 2016. / Harmonic Ace™* +7 on max mode and Olympus Thunderbeat™* on default setting 1 of seal/cut mode
Bringing Value with Versatility. / Redefining Versatility. - Based on internal test report #RE00041188, Validation marketing claims: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine labs. October 2015 and February 2016. / 29 out of 29 surgeons evaluated agreed / Based on internal test report #RE00032739 Rev A, Ligasure™ Hook (LF5637, LF5644) validation surgeon evaluation report: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine lab conducted in Houston, Texas. February 2016.
Fewer Instrument Exchanges. More Possibilities. - Based on internal test report #RE00041188, Validation marketing claims: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine labs. October 2015 and February 2016. / 27 out of 29 surgeons evaluated agreed / 29 out of 29 surgeons evaluated agreed
1. Morris TA, Gay PC, MacIntyre NR, Hess DR, Hanneman SK, Lamberti JP, Doherty DE, Chang L, Seckel MA. Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients. Respir Care. 2017 Apr;62(4):497-512.
2. Hodgetts TJ, Kenward G, Vlackonikolis I, et al. Incidence, location and reasons for avoidable in-hospital cardiac arrest in a district general hospital. Resuscitation. 2002;54(2):115-123.
1. Morris TA, Gay PC, MacIntyre NR, Hess DR, Hanneman SK, Lamberti JP, Doherty DE, Chang L, Seckel MA. Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients. Respir Care. 2017 Apr;62(4):497-512.
2. Hodgetts TJ, Kenward G, Vlackonikolis I, et al. Incidence, location and reasons for avoidable in-hospital cardiac arrest in a district general hospital. Resuscitation. 2002;54(2):115-123.
1. Based on internal test report #RE00077194, Bag and device reliability memo. 2016.
2. Based on internal test report #RE00007964, ReliaCatch™ specimen retrieval bag summative validation. 2016.
3. Based on internal test report #RE00072916, ReliaCatch™ specimen retrieval bag 10 mm and 12 mm claims matrix benchmark data. Ethicon, Applied, Anchor, and Genicon are considered the major competitors and ReliaCatch™ device was tested appropriately against their specimen retrieval devices. For CATCH10, as compared with Applied Inzii™*, Anchor Tissue Retrieval System™*, Ethicon EndoPouch™*, Genicon GeniStrong™* and predicate Endo Catch™ Gold device. For CATCH12, as compared with Genicon GeniStrong™* 12 mm and Applied Inzii™* 12/15 mm. 2016.
4. Based on internal test report #RE00070348, Specimen retrieval devices: Specification development & justification. As compared to predicate Endo Catch™ Gold device. 2016.
1. Omotosho P, Yurcisin B, Ceppa E, Miller J, Kirsch D, Portenier DD. In vivo assessment of an absorbable and nonabsorbable knotless barbed suture for laparoscopic single-layer enterotomy closure: a clinical and biomechanical comparison against nonbarbed suture. J Laparoendosc Adv Surg Tech A. 2011;21(10):893-897.
2. Adams JB, Schulam PG, Moore RG, Partin AW, Kavoussi LR. New laparoscopic suturing device: initial clinical experience. Urology. 1995; 46(2):242-245.
3. Stringer NH. Laparoscopic myomectomy with the Endo Stitch™ 10 mm laparoscopic suturing device. J Am Assoc Gynecol Laparosc. 1996; 3(2):299-303.
4. Nguyen NT, Mayer KL, Bold RJ, et al. Laparoscopic suturing evaluation among surgical residents. J Surg Res. 2000; 93(1): 133-136.
5. Pattaras JG, Smith GS, Landman L, Moore RG. Comparison and analysis of laparoscopic intracorporeal suturing devices: preliminary results. J Endourol. 2001;15(2):187-192.
6. Hart S, Hashemi L, Sobolewski CJ. Effect of a disposable automated suturing device on cost and operating room time in benign total laparoscopic hysterectomy procedures. JSLS. 2013. 17(4):508–516.
7. Based on a five-year retrospective view of internal COGNOS data and extrapolated sales calculations.
8. Brown, S. Utilization of a porcine model to demonstrate the efficacy of an absorbable barbed suture for dermal closure. UTSW. 2009.
9. Rubin JP, Hunstad JP, Polynice A, et al. A multicenter randomized controlled trial comparing absorbable barbed sutures versus conventional absorbable sutures for dermal closure in open surgical procedures. Aesthet Surg J. 2014; 34: 272-283.
10. Zaruby J, Gingras K, Taylor J, Maul D. An in vivo comparison of barbed suture devices and conventional monofilament sutures for cosmetic skin closure: biomechanical wound strength and histology. Aesthet Surg J. 2011;31(2):232-240. doi: 10.1177/1090820X10395010
11. Gingras K, Zaruby J, Maul D. Comparison of V-Loc™ 180 wound closure device and Stratafix™* Spiral knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength. J Biomed Mater Res Part B Appl Biomater. 2012;100(4):1053-1058.
†Compared to the competitive closure device, suture passers, and hand sutures.
1. Based on internal validation report #RE00098009 Rev A, DoubleTime VersaOne™ fascial closure system Miami lab VOCreport: 13 out of 16 surgeons surveyed agreed. March 28, 2017.
†Preclinical results may not correlate with performance in humans.
1. Based on internal test report #R2146-151-0, Powered stapling firing speed DOE analysis and ASA parameters. 2015.
2. Based on internal test report #R2146-173-0, ASA verification testing with slow speed force limit evaluation. 2015.
3. Based on internal test report #RE00024826, Signia™ stapling system summative usability report. January 2016.
When compared to Echelon Flex™* green reloads as part of an analysis comparing different stapler designs and their performance and impact on tissues under compression using two-dimensional finite element analysis. Sept. 2, 2011. Testing performed with Endo GIA™ staplers, not Signia™ loading units with Tri-Staple™ 2.0 cartridges.
Based on internal test report #2128-002-2, Final analysis of staple line vascularity using MicroCT. April 27, 2015. Testing performed with Endo GIA™ staplers, not Signia™ loading units with Tri-Staple™ 2.0 cartridges.
Based on internal test report #PCG-001, Tyvek pull-apart test comparing Echelon™* and Tri-Staple™ technology. March 2011.
Based on internal test report #PCG-004, Undercrimp comparisons in increasing pads of foam between Echelon™* and Tri-Staple™ technology. January 2012.
Based on internal test report #PCG-006, Staple formation comparison between Medtronic EGIA60AXT and Ethicon ECR60G in an ex vivo tissue model. January 2012.
Based on internal test report #PCG-018, 2-D FEA of linear staplers. November 2012.
Based on internal test report #PCG-019, Comparative test of Medtronic Endo GIA™ black reloads with Tri-Staple™ technology and Ethicon Echelon Flex™* black reloads. June 2014.
Preclinical results may not correlate with performance in humans.
† Preclinical results may not correlate with performance in humans.
1. Based on internal test report #RE00128041, Vessel tension testing: Comparing Endo GIA™ curved tip reloads with Tri-Staple™ technology to Echelon Flex™* PVS as part of a benchtop simulated tissue model to illustrate and evaluate tension during stapling reload closure. Dec. 4, 2017.
2. Compared to uniform staple closure and pivoting anvil reloads. Based on internal test report #RE00128041_Rev 1, Vessel tension analysis: Comparing Endo GIA™ curved tip
1. Based on internal test report #R0064457 rev C, LigaSure™ technology renal bench burst pressure evaluation of the Valleylab™ FT10 energy platform. January 2015.
†Compared to Spacemaker™ Plus device or PDB distention balloons
†‡Compared to Spacemaker™ Plus device
References:
1. Based on internal design verification report #RE00010041, Spacemaker™ Pro access and dissector system. December 2014.
2. Based on internal validation report #RE00013395, Spacemaker™ Pro access and dissector system. June 2015.
3. Spacemaker™ Pro access and dissectgor system [instructions for use]. Mansfield, MA: Medtronic; 2014.
†10 out of 10 surgeons surveyed after use agreed the device improved visualization vs. nonevacuation.
‡As compared with non-ULPA filtration or nonevacuation.
1. Based on internal test report #RE00139506 rev A, Bourbon: Valleylab™ laparoscopic smoke evacuation system nurses and surgeons claims report. March 12, 2018.
2. da Silva RD, Sehrt D, Molina WR, Moss J, Park SH, Kim FJ. Significance of surgical plume obstruction during laparoscopy. JSLS. 2014;18(3).
3. Based on Buffalo Filter report #PR-17003 rev A, ULPA filtration. Jan. 12, 2018.
†10 out of 10 surgeons and nurses surveyed after use agreed for active mode the device improved visualization vs. nonevacuation.
‡8 out of 9 surgeons and nurses surveyed after use agreed for passive mode.
§As compared with non-ULPA filtration or nonevacuation.
1. Based on internal test report #RE00139506 rev A, Bourbon: Valleylab™ laparoscopic smoke evacuation system nurses and surgeons claims report. March 12, 2018.
2. da Silva RD, Sehrt D, Molina WR, Moss J, Park SH, Kim FJ. Significance of surgical plume obstruction during laparoscopy. JSLS. 2014;18(3).
3. Based on the manufacturer report #PR-17003 rev A, ULPA filtration. Jan. 12, 2018.
†Up to and including 7 mm.
1. LigaSure™ Maryland Jaw Thoracic Sealer/Divider, One-Step Sealing, Nano-Coated [instructions for use]. Boulder, CO: Medtronic; 2018.
2. Based on internal report #RE00138840, LIG-45 memo, device length recommendation, thoracic (LF1930T). Feb. 6, 2018.
3. Based on internal test report #RE00125866, Jaw force and gap range burst pressure evaluation of EB4 thoracic Maryland device (LF1930T); conducted on bovine tissue. Nov. 20–21, 2017 and Nov. 27–30, 2017.
4. Based on internal test report #RE00134865, Burst Pressure Verification of Pulmonary Bovine Veins (LF1930T). Jan. 17-18, 2018.
5. Based on internal test report #RE00122515, Verification of the LigaSure™ LF1930T Device in a GLP Chronic Hemostasis Canine Study on Pulmonary Vasculature. Jan. 8-10, 2018.
6. Based on internal test report #RE00128442, GLP Acute Pulmonary Vasculature Hemostasis Verification Study of the LF1930T in Hounds. Dec. 8, 2017.
1. Based on internal test report #PCG-019, Comparative testing of Covidien Endo GIA™ black reloads with Tri-Staple™ technology and Ethicon Flex™* black reloads. June 2014.
2. Based on internal test report #PCG-006_Rev1, Staple line evaluation of two staple designs (Endo GIA™ black 60 mm reloads with Tri-Staple™ technology and Echelon Flex™* green 60 mm reloads) in explanted porcine stomachs.†
3. Based on internal test report #PCG-007 rev 1, When compared to Echelon Flex™* green reloads as part of an analysis comparing different stapler designs and their performance and impact on tissues under compression using two-dimensional finite element analysis. Sept. 2, 2011.†
4.Based on internal test report #2128-002-2, Final analysis of staple line vascularity using MicroCT. July 2015.†
5. Based on internal test report #PCG-029, Intuitive Surgical™* stapling competitive analysis: head-to-head comparison of ex vivo firings in porcine stomach. Nov. 15, 2016.†
6. Hagen ME, Jung MK, Fakhro J, et al. Robotic versus laparoscopic stapling during robotic Roux-en-Y gastric bypass surgery: a case-matched analysis of costs and clinical outcomes. Surg Endosc. 2017 Jul 19. doi: 10.1007/s00464-017-5707-6. [Epub ahead of print]
†Preclinical results may not correlate with clinical performance in humans.
‡In a head-to-head comparison of ex vivo firings in porcine stomach using Tri-Staple™ technology purple reload versus Intuitive Surgical™* green reload.
†As compared to conventional sutures.
‡As a pre-clinical comparison to conventional sutures.
1. Fouda UM, Elsetohy KA, Elshaer HS. Barbed versus conventional suture: A randomized trial for suturing the endometrioma bed after laparoscopic excision of ovarian endometrioma. J Minim Invasive Gynecol. 2016;23(6):962–968.
2. Krishnamoorthy B, Shepherd N, Critchley WR, Nair J, et al. A randomized study comparing traditional monofilament knotted sutures with barbed knotless sutures for donor leg wound closure in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2016;22(2):161-7.
3. Zaruby J, Gingras K, Taylor J, Maul D. An in vivo comparison of barbed suture devices and conventional monofilament sutures for cosmetic skin closure: biomechanical wound strength and histology. Aesth Surg J. 2011;31(2):232–240.
† Compared to the LigaSure™ small jaw device;16 out of 16 surgeons surveyed agreed.
‡ 11 out of 13 surgeons surveyed agreed.
§ 11 out of 12 surgeons surveyed agreed.
ΩA fter five activations.
1. Based on internal report #RE00114823, Validation labs: surgeon evaluation of LigaSure™ exact dissector, nanocoated. July 18 to 26, 2017.
2. Based on internal report #RE00107711 Rev A, Market research: thermal profile comparison of LigaSure™ exact dissector and the Ethicon Harmonic Focus™*+ conducted on porcine tissue. August 2017.
US180719–[WF#2408477]
†29 out of 33 surgeons surveyed after use agreed.
‡ 29 out of 29 nurses surveyed after use agreed.
1. Based on internal test report #RE00147772 rev A, Sabre blade comparison report. April 18, 2018.
2. Based on internal test report #R0042752 rev A, Marketing evaluation of surgeon experience using the Sonicision™ curved jaw cordless ultrasonic dissector. Feb. 13–17, Feb. 28, March 3, May 16, 2017.
3. Based on internal test report #R0049393 rev A, Operating room staff marketing evaluation of the Sonicision™ curved jaw cordless ultrasonic dissector. Dec. 1, 6–7, 2016.
† 29 out of 33 surgeons surveyed after use agreed.
‡ 29 out of 29 nurses surveyed after use agreed.
1. Based on internal test report #RE00147772 rev A, Sabre blade comparison report. April 18, 2018..
2. Based on internal test report #R0042752 rev A, Marketing evaluation of surgeon experience using the Sonicision™ curved jaw cordless ultrasonic dissector. Feb. 13–17, Feb. 28, March 3, May 16, 2017.
3. Based on internal test report #R0049393 rev A, Operating room staff marketing evaluation of the Sonicision™ curved jaw cordless ultrasonic dissector. Dec. 1, 6–7, 2016.
4. Brogmus G, Leone W, Butler L, Hernandez E. Best practices in OR suite layout and equipment choices to reduce slips, trips, and falls. AORN J. 2007;86(3):384–394.
†29 out of 33 surgeons surveyed after use agreed.
‡ 29 out of 29 nurses surveyed after use agreed.
1. Based on internal test report #RE00147772 rev A, Sabre blade comparison report. April 18, 2018.
2. Based on internal test report #R0042752 rev A, Marketing evaluation of surgeon experience using the Sonicision™ curved jaw cordless ultrasonic dissector. Feb. 13–17, Feb. 28, March 3, May 16, 2017.
3. Based on internal test report #R0049393 rev A, Operating room staff marketing evaluation of the Sonicision™ curved jaw cordless ultrasonic dissector. Dec. 1, 6–7, 2016.
† Finite element analysis (FEA) was used to determine the strain profiles of three circular staplers during clamp-up: EEA™ circular stapler with Tri-Staple™ technology, EEA™ stapler with DST Series™ technology, and Ethicon Intraluminal Circular Stapler. The EEA™ circular stapler with Tri-Staple™ technology demonstrated a graduated compression profile upon clamping.
‡ Compared to two row staplers.
§ Based on the addition of a third row of staples in the EEA™ circular stapler with Tri-Staple™ technology, as compared to predicate two-row device designs.
Ω Refers to the healing period (generally through day 28) that was evaluated in multiple preclinical (canine) survival studies designed to assess device safety and efficacy.
†† Preclinical results may not correlate with clinical performance in humans.
1. Based on internal test report #PCG-007, Media absorbency under clamped conditions. Aug. 6, 2012.
2. Based on extrapolation of perfusion studies performed for Endo GIA™ with Tri-Staple™ technology: internal test report #2128-002-2, Final analysis of staple line vascularity using MicroCT. April 27, 2015.
3. Based on internal test report #2128-194, Comparison of EEA™ circular stapler with Tri-Staple™ technology to EEA™ circular stapler with DST Series™ technology in colocolonic and gastrojejunal anastomoses. Aug. 20, 2015.
4. Based on internal test report #RE0036707, Pilot: comparison of EEA™ circular stapler with Tri-Staple™ technology to EEA™ circular stapler with DST Series™ technology in an esophago-gastrostomy using a canine model. Feb. 25, 2015.
5. Based on internal test report #2128-097, Evaluation of early wound healing events in gastrojejunostomies and colonic anastomosis using a three row EEA™ stapler in canines. Aug. 7, 2013.
†Top hospitals according to U.S. News & World Report Best Hospitals 2020 edition.
1. Based on internal Cognos reporting as of August 2019.
†As compared to conventional sutures.
‡Based on tests using an animal model. Animal data is not necessarily indicative of human clinical outcomes.
§Animal data may not correlate with human clinical outcomes.
ΩBased on ex vivo testing.
††Based on bench test model for simulated intracorporeal knot tying and laparoscopic suturing.
‡‡Endo Stitch enables faster suturing as compared to conventional suturing.
1. Omotosho P, Yurcisin B, Ceppa E, Miller J, Kirsch D, Portenier DD. In vivo assessment of an absorbable and nonabsorbable knotless barbed suture for laparoscopic single-layer enterotomy closure: a clinical and biomechanical comparison against nonbarbed suture. J Laparoendosc Adv Surg Tech A. 2011;21(10):893-897.
2. Adams JB, Schulam PG, Moore RG, Partin AW, Kavoussi LR. New laparoscopic suturing device: initial clinical experience. Urology. 1995; 46(2):242-245.
3. Stringer NH. Laparoscopic myomectomy with the Endo Stitch™ 10 mm laparoscopic suturing device. J Am Assoc Gynecol Laparosc. 1996; 3(2):299-303.
4. Nguyen NT, Mayer KL, Bold RJ, et al. Laparoscopic suturing evaluation among surgical residents. J Surg Res. 2000; 93(1): 133-136.
5. Pattaras JG, Smith GS, Landman L, Moore RG. Comparison and analysis of laparoscopic intracorporeal suturing devices: preliminary results. J Endourol. 2001;15(2):187-192.
6. Hart S, Hashemi L, Sobolewski CJ. Effect of a disposable automated suturing device on cost and operating room time in benign total laparoscopic hysterectomy procedures. JSLS. 2013. 17(4):508–516.
7. Based on a five-year retrospective view of internal COGNOS data and extrapolated sales calculations.
8. Brown, S. Utilization of a porcine model to demonstrate the efficacy of an absorbable barbed suture for dermal closure. UTSW. 2009.
9. Rubin JP, Hunstad JP, Polynice A, et al. A multicenter randomized controlled trial comparing absorbable barbed sutures versus conventional absorbable sutures for dermal closure in open surgical procedures. Aesthet Surg J. 2014; 34: 272-283.
10. Zaruby J, Gingras K, Taylor J, Maul D. An in vivo comparison of barbed suture devices and conventional monofilament sutures for cosmetic skin closure: biomechanical wound strength and histology. Aesthet Surg J. 2011;31(2):232-40.
11. Ahmed O, Jilani D, Funaki B, Ginsburg M, et al. Comparison of barbed versus conventional sutures for wound closure of radiologically implanted chest ports. J Vasc Interv Radiol. 2014;25(9):1433-8.
12. Koide S, Smoll NR, Liew J, Smith K, et al. A randomized 'N-of-1' single blinded clinical trial of barbed dermal sutures vs. smooth sutures in elective plastic surgery shows differences in scar appearance two-years post-operatively. J Plast Reconstr Aesthet Surg. 2015;68(7):1003-9.
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†15 out of 16 surgeons surveyed after use agreed when compared to larger 12 mm reloads.
‡Compared to the Echelon Flex™* powered vascular stapler 35 mm white 2.5 mm cartridge reloads.
§Tested using the Endo GIA™ handle with Signia™ small diameter 30 mm grey 2.0 mm reload versus Ethicon Echelon Flex™* powered vascular stapler with 35 mm white 2.5 mm reload. Preclinical results may not correlate with clinical performance.
1. Based on internal report #RE00014682, Small diameter reload summative usability. June 19–20, 22, 2017.
2. Based on internal report #RE00209946, Vessel tension analysis: Signia™ small diameter reload vs. Echelon™ PVS. Sept. 17, 2019.
3. Based on internal report #RE00190239, Signia™ small diameter reload chronic study statistical analysis. March 26, 2019.
† When compared to conventional sutures.
1. Koide S, Smoll NR, Liew J, Smith K, et al. A randomized 'N-of-1' single blinded clinical trial of barbed dermal sutures vs. smooth sutures in elective plastic surgery shows differences in scar appearance two-years post-operatively. J Plast Reconstr Aesthet Surg. 2015;68(7):1003-9.
2. Rubin JP, Hunstad JP, Polynice A, Gusenoff JA, et al. A multicenter randomized controlled trial comparing absorbable barbed sutures versus conventional absorbable sutures for dermal closure in open surgical procedures. Aesthet Surg J. 2014;34(2):272-83.
3. Liang DG, Dusseldorp JR, van Schalkwyk C, Hariswamy S, et al. Running barbed suture quilting reduces abdominal drainage in perforator-based breast reconstruction. J Plast Reconstr Aesthet Surg. 2016;69(1):42-7.
†As of Aug. 11, 2020, based on indications for use for electrosurgical cutting and coagulation device and accessories in the FDA 510(k) database over the last 10 years. The BiZact™ device is indicated for adult, children, and adolescent tonsillectomy procedures (3 years of age and above).
‡Used in 48 cases, including adults (22+) US (18+) EU the use of the BiZact™ tonsillectomy device resulted in non-measurable bloodloss compared to published literature stating 10.83 ml for Coblator™* and 27.08 for electrocautery [Roje] and 125 ml [Lachanas] with cold knife
1. Based on internal report RE00213922, Pediatric indication claims for the BiZact Tonsillectomy Device BZ4212A (memo). March 5, 2020.
2. Karni, R., Attner, P. (2018). A prospective, multi-center, single arm, non-comparative pilot study of BiZact on adults undergoing tonsillectomy. Data on file. Study sponsored by Medtronic. ClinicalTrials.gov Identifier: NCT02876575
3. Roje Z, Racić G, Dogas Z, Pisac VP, Timms M. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blinded study. Coll Antropol. 2009;33(1):293–298.
4. Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–1594.
†Compared to the current device they are using; 15 out of 19 surgeons surveyed agreed.
‡15 out of 19 surgeons surveyed agreed.
1. Ball K. Surgical smoke evacuation guidelines: compliance among perioperative nurses. AORN J. 2010; 92(2):e1–e23.
2. Laser/Electrosurgery Plume. Occupational Safety & Health Administration Website. http://www.osha.gov/SLTC/laserelectrosurgeryplume. February 2016.
3. Based on internal test report #RE00125194 rev A, Surgical validation report. July 2018.
4. Based on internal test report #R0038994 rev A, Non-IEC verification report: smoke evacuation test. July 2018.
5.Based on internal test report #RE000128533 rev A, Marketing claims validation report. July 2018.
1. Based on radiofrequency and ultrasonic market share data, generated from IQVIA market reports: CY2013- CY2018. Data on file at Medtronic. IQVIA market reports CY2013-CY2018, from IMS-SKU-Level-Data_Q4CY17.xls and IMS-SKU-Level-Data_Q4CY18.xls.
†Results based on bench testing.
1. Based on internal test report #RE00002249. Clearify™ visualization system baseline report. November 2014.
2. Based on internal test report #RE00002250. Clearify™ visualization system line transfer qualification. November 2014.
† Using an absorbable mesh to reinforce the staple line when compared to glue, bovine pericardial strips, suturing, or no reinforcement after sleeve gastrectomy.
‡ Based on a meta analysis of 148 articles representing 40,653 patients compared to no reinforcement. P < 0.0001.
§ Results based on n of 125 OR nurses and 125 surgeons.
Ω Compared to separately loaded material.
†† After laparoscopic sleeve gastrectomy vomiting at 24 hours: P = 0.041; nausea: P = 0.05.
‡‡ P = 0.042
§§Compared to nonbuttressed reloads. P = 0.006.
ΩΩ Compared to Seamguard™*.
†††Bench test results may not necessarily be indicative of clinical performance.
‡‡‡ In-vitro tensile strength compared to Seamguard™*.
1. Gagner M, Kemmeter P. Comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review. Surg Endosc. 2020; 34: 396–407. doi:10.1007/s00464-019-06782-2.
2. Based on internally-sponsored study conducted by ORC International, Survey of tissue reinforcement users to determine waste and time loss attributed to separately loaded buttress materials in the OR. Online U.S. national sample of 125 surgeons and 125 OR nurses. Nov. 9, 2011.
3. Ruiz-Tovar J, Zubiaga L, Muñoz JL, Llavero C. Incidence of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy with staple line reinforcement with oversewing and staple line inversion vs buttressing material: A randomized clinical trial. Int J Surg. 2018;59:75–79.
4. Gayrel X, Loureiro M, Skalli EM, Dutot C, et al. Clinical and economic evaluation of absorbable staple line buttressing in sleeve gastrectomy in high-risk patients. Obes Surg. 2016; 26: 1710–1716. doi:10.1007/s11695-015-1991-1.
5. Deguchi H, Tomoyasu M, Shigeeda W, Kaneko Y, Kanno H, Saito H: Reduction of air leakage using linear staple device with bioabsorbable polyglycolic acid felt for pulmonary lobectomy. Gen Thorac Cardiovasc Surg. 2019; doi: 10.1007/s11748-019-01207-2.
6. Based on internal report #RE00240873, Comparison of Tri-Staple™ 2.0 reinforced reload PGA buttress material vs. Gore Seamguard™* [Reinforcement buttress material using 2-sample t-tests. Data calculated with 95% confidence using Minitab™* (p < 0.0001)]. Dec. 02, 2019.
†Compared to GIA™ staplers with DST Series™ technology
1. Based on report #RE00171002 rev 0, 80 mm GIA™ stapler with Tri-Staple™ technology purple and black design verification report. Aug. 14, 2019.
2. Based on report #RE00218526, R&D memo. Aug. 27, 2019.
†Bench test results may not necessarily be indicative of clinical performance.¬
1. Based on internal test report #00452, Summary of bench testing performance data on VS3-IR system with camera, endoscope-IR and MMS-IR. March 2020. Medtronic data on file.
2. Bigdeli AK, Gazyakan E, Schmidt VJ, Hernekamp FJ, Harhaus L, Henzler T. Indocyanine green fluorescence for free-flap perfusion imaging revisited: advanced decision making by virtual perfusion reality in Visionsense™ fusion imaging angiography. Surg Innovation. 2015;23(3):1–12
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†Bench test results may not be indicative of clinical performance.
‡Animal data may not correlate with human clinical outcomes.
1. Colak E, Ozlem N, Kucuk O. Prospective randomized trial of mesh fixation with absorbable versus nonabsorbable tacker in laparoscopic ventral incisional hernia repair. Int J Clin Exp Med. 2015;8(11):21611-21616.
2. Based on internal report #TD1025, Mechanical evaluation of AbsorbaTack™, ProTack™, and SECURESTRAP™ in shear mode using foam media. January 2012.
3. Based on internal report # RE00003170-2, ReliaTack™ Phase II In-vitro Mass Loss. July 2016.
4. Hollinsky, C., Kolbe, T., Walter, I. et al. Tensile strength and adhesion formation of mesh fixation systems used in laparoscopic incisional hernia repair. Surg Endosc.2010 Jun;24(6):1318-1324.
5. Based on internal AbsorbaTack™ Tack Drawing 3010439. May 2008.
1. Based on internal test report #T2291CR037a. Evaluation of Parietene™ macroporous mesh evaluation by surgeons for design validation. June 2014.
1. Hopson SB, Mille LE. Open Ventral hernia repair using ProGrip™ self-gripping mesh. Int J Surg. 2015;23(Pt A):137–140.
2. Based on internal report #0506CR066. Marketing assessment Parietex™ composite ventral patch. March 2012
†As compared with nonULPA filtration or nonevacuation.
§The Situate™ detection system is an adjunct to manual counting.
1. Based on internal report #PR-17003, Valleylab™ laparoscopic smoke evacuation, ULPA verification. January 8, 2018.
2. Based on internal test report #R0043188A, Orion system basic system functionality. April 22, 2015.
3. Based on internal test report #RE00034518 Rev D, Console Software Design, Situate™ detection system. Oct. 4, 2019.
4. Mehtsun WT, Ibrahim AM, Diener-West M, Pronovost PJ, Makary MA. Surgical never events in the United States. Surgery. 2013;153(4):465–472.
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