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Johnson & Johnson Medical Devices has a breadth of experience in spinal surgery, DePuy Synthes & Ethicon are collaborating to provide a total end-to-end procedural solution from Skin, to Bone, to Home - offering procedural innovations designed to help spine patients get home sooner.
Working as One Company to support a Seamless Spine Surgery to help your patients from Skin, to Bone, to Home.
We understand the unprecedented pressure you face to get through the backlog of spine patients waiting surgery. There has never been a more important time to minimise complications and risks during surgery, to help your patient return home as quickly as possible.
Bleeding management during your procedure, reducing the risk of an SSI through appropriate wound care, and optimising your surgical procedure and patient pathway are all key to achieving this, which in turn will improve clinical outcomes, reduce length of stay and reduce readmission rates in spinal surgery.
Supporting you from the first skin incision, during surgery and aftercare, taking you and your patient from Skin, to Bone, to Home through a seamless operation.
Offering a comprehensive portfolio of adjunctive haemostats for bleeding management.
Offering an expansive portfolio of spinal care solutions and treatment options which are available in key areas including thoracolumbar, cervical, aging spine, interbody fusion.
Offering advances in wound closure that enable you to optimise wound healing.
Patient Pathway & Process Improvement
Our vision is to be a value-added offering to our healthcare partners. We are seeking to support to recovery from the impact of COVID-19 and have identified a range of areas where our teams have expertise to help.
Simple, efficient, and consistent control over continuous oozing bleeding.1-5*
Demonstrated in vitro bactericidal activity against the most common pathogens (MRSA, MRSE, VRE, PRSP, E. coli).6-9
Innovative solutions for continuous oozing bleeding.3,4**
SURGICEL™ Powder penetrates the blood to stop bleeding at the source, achieving hemostasis in a wet field.10,11
The SURGICEL™ Powder efficient device keeps powder securely in place until surgeon is ready to deploy and modulates the amount of powder per pump for consistent expression regardless of device orientation.12
Surgiflo™ Hemostatic Matrix with thrombin provides a matrix for platelet adherence and aids in fibrin clot formation.4 Stops Bleeding before FLOSEAL™ is ready to use.13,14,^
SURGIFLO™ is backed by extensive clinical data. A systematic review and meta-analysis of 6 clinical studies across 39,660 patients, evaluated its effectivenes and safety across the following endpoints: Blood Transfusions, Minor/Major Complications, Surgical/Operating time.15***
DePuy Synthes Spine
The PROTI 360°™ Ti Integrated Technology is designed to leverage the benefits of both PEEK and titanium. This family of products offers surgeons a range of implants that are designed to participate in fusion.
FIBERGRAFT bone graft substitutes are created from a matrix of bioactive glass fibres and microspheres. This matrix provides continuous porosity, direct connectivity, high surface area, and resorption rates consistent with bone formation.34-36
FIBERGRAFT is a registered trademark of Prosidyan, Inc.
3D printed cellular titanium implants that feature 80% porous macro-, micro- and nanostructures, are designed to mimic cortical and cancellous bone, and facilitate fusion.37,38 The CONDUIT™ Interbody Platform also offers additional insertion positioning options, including Lateral/Antero-Lateral for the Lateral cage, and Anterior/Antero-Lateral for the ALIF cage.
The DePuy Synthes Spine SYMPHONY™ Occipito-Cervico-Thoracic (OCT) System is an enhanced set of instruments and implants, including polyaxial screws, 3.5 mm and 4.0 mm rods, compatible hooks, cross connectors, lateral offset connectors, and rod connectors designed to address the unmet needs in the posterior upper spine including fixation, alignment, targeting, and extension (FATE).
The EXPEDIUM VERSE® System is designed for the treatment of multiple patient pathologies including adult deformity, complex degenerative, pediatric AIS (adolescent idiopathic scoliosis) and trauma.
The VIPER PRIME™ System is a technique for percutaneous pedicle screw placement that eliminates the need for guidewires, Jamshidi needles and pedicle preparation instruments.
DERMABOND™ PRINEO™ Skin Closure System provides a flexible microbial barrier with 99% protectionin vitro for 72 hours against organisms commonly responsible for SSIs.16#
DERMABOND™ PRINEO™ Skin Closure System may reduce the final layer of skin closure time by as much as 84% compared to intradermal sutures p<0.0001.17,18
DERMABOND™ PRINEO™ Leads to greater overall patient satisfaction compared to staples.19,20†, ††
With significantly more points of fixation than traditional sutures, STRATAFIX™ Knotless Tissue Control Devices provide a combination of more security, more consistency, and more efficiency.21-30
Plus™ Antibacterial Sutures
Triclosan-coated sutures have been shown in multiple meta- analyses to reduce the risk of SSIs by 28%.31-33
Disclaimer: The petri dish image is for illustrative purposes only, zone of inhibition testing results can vary.
Footnotes & References
*Simple – comprised exclusively of oxidized regenerated cellulose, efficient – faster time to hemostasis compared to SURGICEL™ Original in animal models, consistent – preclinical study demonstrated hemostasis in all experimental sites applied with SURGICEL™ Snow.
**Each SURGICEL™ product was the first ORC to market in its construction.
***Compared to Floseal™, with both products demonstrating a similar safety and effectiveness profile.
^Taking into consideration that: SURGIFLO™ Hemostatic Matrix is twice as fast to prepare versus Floseal (81 vs.163 seconds) and requires no measuring. Specific time 81 vs 163 seconds and that SURGIFLO™ Hemostatic Matrix with thrombin performs similarly to Floseal, achieving hemostasis within approximately 60 seconds of application, in animal models.
#Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Enterococcus faecium.
†Double-blinded quantitative research study comparing surgeon experience with DERMABOND™ PRINEO™ System and skin staples in total knee arthroplasty. N=83 orthopaedic surgeons. 90% c.I. Fielded June/July 2017.
††In a TKA in US patients and surgeons.
1. Ethicon, 12072012, Biosurgery SNoW Marketing Claims Report, July 2012, Data on File.
2. Ethicon, 29012009, Comparison of SURGICEL Non-Woven and SURGICEL Original in the acute swine splenic incision hemostasis model, January 2009, Data on File.
3. Ethicon, 18082018, SURGICEL™ Technical Report, August 2018, Data on File.
4. Ethicon, SNoW IFU, 11.07.2014, Data on File.
5. Ethicon, 20072020, Claim Support for SURGICEL™ SNoW: Simple, efficient, and consistent control over continuous oozing bleeding, July 2020, Data on File.
6. Spangler D, Rothenburger S, Nguyen K, Jampani H, Weiss S, Bhende S, In Vitro Antimicrobial Activity of Oxidized Regenerated Cellulose Against Antibiotic-Resistant Microorganisms. Surgical Infections. 2003;4(3): 255-262.
7. Dineen P. The effect of oxidized regenerated cellulose on experimental infected splenotomies. J Surg Res 1977;23:114-116.
8. SURGICEL™ Absorbable Hemostat. Instructions for Use, Ethicon, Inc.
9. Ethicon, 056876- 160721 EMEA Surgicel Technical Report, October 2013, Ethicon Biosurgery internal document. Data on file.
10. Wang A. Surface energy/tension analysis among ORC aggregate, ORC fine fiber and Arista Project PIXIE. 2014;31;3251-3264.
11. Ethicon, 09022015, Pivotal study comparing performance of SURGICEL™ Powder Absorbable Hemostatic Powder to ARISTA™ Absorbable Hemostatic Particles and PerClot® Polysaccharide Hemostatic System in a swine acute live biopsy model, September 2015, Data on file.
12. Ethicon,100293850-1,Expression testing-ADAPTIV Document, March 2017, Data on file.
13. Ethicon, MD-TMSR-512-204.01 SURGIFLO™ Hemostatic Matrix Kit with Thrombin, Dec 2013, Data on File.
14. Ethicon, 07102013, Evaluation of the dose response curve for Hemostatic Efficacy of Surgiflo Next Generation mixed with Thrombin, Oct 2013, Data on File.
15. Palleja, Systematic Revision and Meta-Analysis of Geletin Thrombin Hemostatic Matrices for Bleeding Control, Value in Health. 2016;19;3;A311.
16. Ethicon, 06TR071 Study Report for in vitro evaluation of microbial barrier properties of DERMABOND™ ProTape, December 2006, Data on File.
17. Ethicon, 07CS003 Multi-centre study to show equivalence of DERMABOND™ PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions associated with breast procedures, July 2010, Data on File.
18. Ethicon, 06CS005, Multi-centre study to show equivalence of DERMABOND™ PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions, June 2010, Data on File.
19. Ethicon, 30112017 DERMABOND™ PRINEO™ Claims Report, FINAL – November 2017. Data on File.
20. Ethicon, DR#25231-1 DERMABOND™ PRINEO™ - Questions asked to surgeons and results tables. July 2017. Data on File.
21. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.
22. Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
23. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
24. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol
25. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9): e473-e475. doi:10.3928/01477447-20110714-35.
26. Ethicon 100326296 Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX™ Knotless Tissue Control Devices vs Various Products. May 2015. Data on File.
27. Ethicon, AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix™ Spiral in comparison to Monocryl™ in both interrupted and continuous stitching patterns. August 2012. Data on File.
28. Ethicon, AST-2013-0603 Performance Testing of STRATAFIX™ SYMMETRIC PDS™ PLUS Size 0 & 1 Devices – Initiation Strength in Porcine Tissue. April 2014. Data on File.
29. Ethicon, AST-2012-0510. Ethicon Performance Evaluation Memo. Performance Testing of STRATAFIX™ Symmetric Size 2-0 suture device for Tissue Holding Strength with an Incision Defect to Measure Gapping. Dec 2012. Data on File.
30. Ethicon, AST-2013-0056 Performance Testing of STRATAFIX™ Symmetric PDS™ Size2-0 suture device for Tissue Holding Strength with Multiple Incision Defects to Measure Gapping. April 2013. Data on File.
31. de Jonge S, Atema J, Solomkin J and Boermeester M, Meta-Analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. 2017;BJS 104 e118-e133.
32. Wang ZX, Jiang CP, Cao Y, Ding YT. Systematic review and meta-analysis of Triclosan-coated sutures for prevention of surgical-site infection. 2013;100:465-474.
33. Edmiston CE, Daoud FC, Leaper D. Is there an evidence-based argument for embracing an antimicrobial (Triclosan)-coated suture technology to reduce the risk for surgical-site infections? A meta-analysis. 2013; 154:89-100.
34. Walter Eisner. Bioactive Glass Cleared for Postero-Lateral Fusion. Orthopedics This Week. November 17, 2015.
35. S. Bondre, C. Bagga, Prosidyan, Inc. Evaluation of the Nano-Crystalline Hydroxyapatite Forming ability of Novel Bioactive Glass Micro Fiber - Collagen Matrix. Podium presentation, SFB 2018 Annual Meeting, Atlanta, Georgia, April 11-13, 2018.
36. Julian R. Jones. Review of bioactive glass: From Hench to hybrids. Acta Biomaterialia9 (2013) 4457–4486
37. DePuy Synthes, ADAPTIV #103546250, Research Report: CONDUIT – Surface Microstructure Analysis, January 28, 2019, Data on File.
EIT, VAL2016-043 Strut diameter summary rev 0, November 20, 2017, Data on File.