Ethicon Circular stapling portfolio · 2019-08-29 · CIRCULAR™ Powered Stapler addresses...

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Ethicon Circular stapling portfolio Designed to deliver optimal compression for a secure anastomosis

Transcript of Ethicon Circular stapling portfolio · 2019-08-29 · CIRCULAR™ Powered Stapler addresses...

Ethicon Circular stapling portfolioDesigned to deliver optimal compression for a secure anastomosis

1 Koianka T, Kevin M, Martin W, et al. Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection. Annals of Surgery. 2013; 257: 108. 2 Oh SJ, Choi WB, Song J. et al. Complications requiring reoperation after gastrectomy for gastric cancer: 17 years experience in a single institute. J Gastrointest Surg. 2009; 13:239. 3 Kassis E, Kosinski A, Ross P, et al. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013; 96:1919. 4 Schiff A, Brady BL, Ghosh SK, et al. Estimated Rate of Post-Operative Anastomotic Leak Following Colorectal Resection Surgery: A Systematic Review. Journal of Surgery and Surgical Research. 2016;2(1): 060-067. 5 Hammond J, Lim S, Wan Y, et al. The Burden of Gastrointestinal Anastomotic Leaks: an Evaluation of Clinical and Economic Outcomes. J Gastrointest Surg. 2014; 18:1176–1185.6 Benchtop testing in porcine tissue ≤ 30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic EEA2835 (p0.005).

Circular anastomosisClinical challenges Needed: An optimized stapling solution that reduces leaks without compromising perfusion. Tissue tension, poor blood supply and variable tissue thickness can compromise the anastomosis and lead to significant complications. Among complications, anastomotic leaks are a dominant surgical concern due to their high mortality risk.

Postoperative anastomotic leaks occur in up to 12% of colorectal surgeries with mortality reported between 12% and 27%.1

Economic value The impact of postoperative anastomotic leaks on healthcare costs and patient lives can be significant:Patients who had postoperative anastomotic leaks incurred an additional hospital cost of $24,129.5

The cause of anastomotic leaks is multi-factorial, including both patient and surgical factors. With two proprietary technologies, the ECHELON CIRCULAR™ Powered Stapler addresses device-to-tissue interaction and device-to-user interaction to reduce leaks at the staple line without compromising perfusion.6

Claims compared to Medtronic DST Series™ EEA™ Stapler

Up to

4%of gastrectomies2

Up to

11%of esophagectomies3

Anastomotic leak rates

Up to

12%of colorectal resections1

22 times longer length of stay4

2-3 times higher healthcare costs4

3

Claims compared to Medtronic DST Series™ EEA™ Stapler 1 Staple line analysis in benchtop testing, comparing Ethicon CDH25P to Medtronic EEA2535. 2 Benchtop testing on porcine colon, comparing Ethicon CDH29P to Medtronic EEA2835, p<0.001. 3 Users firing in a porcine model, comparing Ethicon CDH29P to Medtronic EEA2835, p=0.003. 4 Benchtop testing, comparing Ethicon CDH29P to Medtronic EEA2835, p=0.001.

ECHELON CIRCULAR™ Powered Stapler Designed to reduce leaks without compromising perfusion—resulting in 61% fewer leaks at the staple line.1

Combining technologies to reduce leaks3D Stapling Technology• Designed with offset closure of the

staple legs, 3D Stapling Technology evenly distributes compression throughout the anastomosis.1

• Reduces potential leak paths.1

Powered firing platform• Delivers 37% less movement at the distal

tip for increased stability.3

• Reduces force to fire by 97% with push button firing.4

• Is designed to help minimize variation in usage and standardize performance across users.

Ethicon ECHELON CIRCULAR™

3D Stapling Technology

Medtronic DST Series™ EEA™

2D Stapling

Conceptual comparison demonstrating potential effects of tissue compression during firing. Results can vary based on tissue characteristics, device design, techniques and other factors.

Illustration depicts actual paths of tip movement during testing—each cube represents a space measuring 5mm.

Conceptual comparison demonstrating potential effects of tissue compression during firing. Results can vary based on tissue characteristics, device design, techniques and other factors.

Gripping Surface Technology• Atraumatic Gripping Surface

Technology gives precise compression only where it is needed2 to prepare the tissue for staple formation.

• Provides gentler handling with a 33% reduction in compressive forces on tissue.2

Ethicon portfolio of circular staplersControlled tissue compression promotes conditions for healingECHELON CIRCULAR™ Powered Stapler and Ethicon Circular Staplers with controlled tissue compression and Adjustable Height Staple Technology are designed to deliver optimal compression for a secure anastomosis.• Controlled closure knob with dual-stage closing mechanism for

quick closure while maintaining fine adjustment of the tissue gap

• Continuously smooth anvil shaft creates less excess tissue draw during anvil closure1,2

• Fixed anvil design causes less tension on the anastomosis with less strain on the staple line during opening3,4

Claims compared to Medtronic DST Series™ EEA™ Stapler

1 Benchtop testing on porcine jejunum, comparing mean tissue draw during anvil closing of the Ethicon CDH25P and Medtronic EEA2535. 0.01cm vs 1.762cm, p=0.001. 2 Benchtop testing on porcine jejunum. Comparing mean tissue draw during anvil closing of the Ethicon Circular Stapler (CDH25A) and the DST Series EEA circular stapler (EEA2535). 0.437cm vs 1.708cm, p<0.05. 3 Benchtop testing on porcine jejunum, comparing mean tissue stretch during anvil opening after firing of the Ethicon CDH25P and the Medtronic EEA2535. 1.148cm vs 1.832cm, p=0.012 4 Benchtop testing on porcine jejunum. Comparing mean tissue stretch during anvil opening after firing of the Ethicon Circular Stapler (CDH25A) and the DST Series EEA circular stapler (EEA2535). 1.558cm vs 2.228cm, p<0.05. 5 Benchtop testing comparing average vibration measured as mean vectorial acceleration during firing. CDH 16.58 m/s2 vs. EEA 3.20 m/s2. 6 Benchtop testing comparing mean peak sound intensity during firing. CDH 109.80 dB(linear) vs. EEA 95.27 dB(linear).

Tissue tension during opening Tissue bunching during closure

Tissue Compression Scale helps surgeons determine compressed tissue thickness during the procedure.

Ethicon Circular StaplersMore device feedback when firingBreakaway washer provides 5x more tactile feedback5 and 16x more audible feedback6

Available in an endoscopically sealed versionShaft designed for endoscopic use with longer shaft length, low-reflective finish and sealed to maintain pneumoperitoneum

Applicable proceduresDesigned for creating anastomosis in bariatric, colorectal and general procedures

For complete product information, including full steps for use, indications, contraindications, warnings and precautions, please see Instruction for Use.

The third party trademarks used herein are trademarks of their respective owners.

©2018 Ethicon, Inc. All Rights Reserved. 075166-170623

ECHELON CIRCULAR™ Powered Stapler

CodeHead diameter

Cartridge type

Staple technology # of staples

Open staple leg length

Closed staple height

Quantity per sales unit

CDH23P 23mm GST 3D 20 5.2mm 1.5–2.2mm 3

CDH25P 25mm GST 3D 22 5.2mm 1.5–2.2mm 3

CDH29P 29mm GST 3D 26 5.2mm 1.5–2.2mm 3

CDH31P 31mm GST 3D 30 5.2mm 1.5–2.2mm 3

Endoscopic Curved Intraluminal Stapler

CodeHead diameter

Cartridge type

Staple technology # of staples

Open staple leg length

Compressed tissue thickness*

Quantity per sales unit

ECS21A 21mm Flat deck B-form 16 5.5mm 1.0–2.5mm 3

ECS25A 25mm Flat deck B-form 20 5.5mm 1.0–2.5mm 3

ECS29A 29mm Flat deck B-form 24 5.5mm 1.0–2.5mm 3

ECS33A 33mm Flat deck B-form 28 5.5mm 1.0–2.5mm 3

Curved Intraluminal Stapler

CodeHead diameter

Cartridge type

Staple technology # of staples

Open staple leg length

Compressed tissue thickness*

Quantity per sales unit

CDH21A 21mm Flat deck B-form 16 5.5mm 1.0–2.5mm 3

CDH25A 25mm Flat deck B-form 20 5.5mm 1.0–2.5mm 3

CDH29A 29mm Flat deck B-form 24 5.5mm 1.0–2.5mm 3

CDH33A 33mm Flat deck B-form 28 5.5mm 1.0–2.5mm 3

* 1.0mm compressed tissue thickness provides 1.5mm closed staple height

How to orderAll purchase orders are made to Johnson & Johnson Health Care Systems, Inc. (JJHCS) or your authorized distributor.

Electronic ordering options(Note: Placing orders electronically avoids minimum order fees for your hospital.)

Johnson & Johnson Gateway: www.jnjgateway.com/commerceFor questions about your order, visit the website or call 1-866-JNJ-GATE (565-4283).

Global Healthcare Exchange (GHX): www.ghx.comFor questions about your order, visit the website or call 1-800-YOUR-GHX (968-7449).

Electronic Data Interchange (EDI): JJHCS EDI Help Line: 1-800-262-2888

Nonelectronic/manual ordering optionsCall JJHCS at 1-800-255-2500 between 8:30 a.m. and 9 p.m. Eastern Standard Time or fax your order to 1-732-562-2212.

Customer supportFor product use assistance, clinical guidelines, service and repair, emergency assistance, copy of a 510(k) clearance letter or complaints, please contact our Customer Support Center at [email protected] or by calling 1-877-ETHICON (384-4266). Our Support Center is staffed 24 hours a day, 7 days a week by qualified nurses to answer your product-related questions.

Ethicon Circular Staplers are available in multiple sizes to allow proper matching of the device to the diameter of the lumen.