Cardiovascular Surgery

Meet the unique challenges of cardiovascular surgery with Ethicon

Our comprehensive portfolio of adjunctive hemostats and wound closure devices continues to grow with innovations that address the challenges of cardiovascular surgery

• Bleeding management • Difficulties of friable tissue • Risk of infection

Ethicon cardiovascular surgery - a comprehensive portfolio - meeting unique challenges for the world’s most perfect machine

Address the challenges of cardiovascular surgery

Address bleeding management with Ethicon surgery products

Bleeding management

Address difficulties of friable tissue with Ethicon surgery products

Difficulties of friable tissue
 

Address risk of infection with Ethicon surgery products

Risk of infection
 

VISTASEAL™ Provides Sustained Hemostasis, Even in High-risk Patients1-3

VISTASEAL™ Fibrin Sealant (Human) mimics the clot formation process and forms a rapid, adherent, durable clot regardless of the patient’s coagulation profile.2,4

Please see Important Safety Information below.

Ethicon VISTASEAL™ Fibrin Sealant (Human) - an adjunctive hemostat for surgery to provide sustained hemostasis

Trust Your Heart to the Strongest Needle of All Time—EVERPOINT®

A stronger, more bend-resistant needle that stays sharp, pass after pass. EVERPOINT® Cardiovascular Needle requires up to 70% less penetration force over 30 passes compared with currently marketed stainless steel needles.11,12

Ethicon EVERPOINT Cardiovascular Needle - strength and bend resistance to address difficulties in friable tissue

Address SSI Risk in Cardiovascular Surgery with Plus Antibacterial Sutures

Meta-analysis demonstrated a 28% reduction in SSI risk with the use of triclosan-coated sutures.13‡§ Meta-regression analysis demonstrated that the effect of Plus Sutures in reducing the risk of SSI did not vary by Centers for Disease Control and Prevention (CDC) wound classification or suture type.13‡§||

Ethicon Plus Antibacterial Sutures to address risk of surgical site infections for wound closure in surgery

Videos

Additional Videos

VISTASEAL in CABG with Dr. Abraham Video
VISTASEAL in CABG with Dr. Abraham Video
06:19
VISTASEAL in Cardiovascular Surgery with Dr. Martella Video
VISTASEAL in Cardiovascular Surgery with Dr. Martella Video
05:58
VISTASEAL Mechanism of Action Video
VISTASEAL Mechanism of Action Video
04:17
VISTASEAL Product Overview Video
VISTASEAL Product Overview Video
08:31
Interview with Dr. Martella on SURGICEL Powder Video
Interview with Dr. Martella on SURGICEL Powder Video
04:29
Interview with Dr. Martella on SURGICEL FIBRILLAR Video
Interview with Dr. Martella on SURGICEL FIBRILLAR Video
03:18
SURGICEL Powder vs ARISTA Video
SURGICEL Powder vs ARISTA Video
04:53
STRATAFIX Symmetric Devices vs V-Loc and Traditional Sutures Video
STRATAFIX Symmetric Devices vs V-Loc and Traditional Sutures Video
02:51
STRATAFIX Symmetric Devices vs Traditional Sutures (Efficiency) Video
STRATAFIX Symmetric Devices vs Traditional Sutures (Efficiency) Video
01:08
DERMABOND PRINEO: Understanding the Science Video
DERMABOND PRINEO: Understanding the Science Video
02:39
The Myth of Wound Breathing Video
The Myth of Wound Breathing Video
03:42
Your Closure Is Their Beginning Video
Your Closure Is Their Beginning Video
02:21

Supporting Documentation

References

*A comparative analysis of the suture hole leak rate of Standard 5-0 PROLENE™ Polypropylene Suture, 5-0 HEMO-SEAL™ Needle Suture, and 5-0 GORE-TEX™ EPTFE non-absorbable monofilament suture following an EPTFE to EPTFE vascular graft anastomosis in an ex vivo cardiopulmonary bypass pulsatile flow loop model with heparinized porcine blood.

†Compared to conventional stainless steel needles.

‡In a meta-analysis of 21 RCTs, 6462 patients, 95% CI: (14, 40%), P<0.001.

§All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL® Plus Antibacterial [poliglecaprone 25] Suture, Coated VICRYL® Plus Antibacterial [polyglactin 910] Suture, and PDS® Plus Antibacterial [polydioxanone] Suture).

||Clean wounds 10 RCTs, 2842 patients, 95% CI: (11, 43%), P=0.003; non-clean wounds 14 RCTs, 3620 patients, 95% CI: (7, 42%).

¶Clinical significance unknown.

1. Chetter I, Stansby G, Sarralde JA, et al. A prospective, randomized, multicenter clinical trial on the safety and efficacy of a ready-to-use fibrin sealant as an adjunct to hemostasis during vascular surgery. Ann Vasc Surg. 2017;45:127-137.

2. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the efficacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections. J Gastrointest Surg. 2018;22:1939-1949.

3. Hunt BJ. Bleeding and coagulopathies in critical care. N Engl J Med. 2014;370:847-859.

4. VISTASEAL™ Fibrin Sealant (Human). Full Prescribing Information. Instituto Grifols, S.A. 2019.

5. Miller CM, Sangiolo P, Jacobson JH. Reduced anastomotic bleeding using new sutures with a needle-suture diameter ratio of one. Surgery. 1987;101(2):156-160.

6. A comparative analysis of the suture hole leak rate of Standard PROLENE® Polypropylene 5-0 Suture with HEMO-SEAL™ technology, and GORE-TEX® EPTFE nonabsorbable monofilament 5-0 suture following an EPTFE to EPTFE vascular graft anastomosis in an ex vivo cardiopulmonary bypass pulsatile low loop model with heparinized porcine blood. Study 14-0233. 2014. Ethicon, Inc.

7. SURGICEL. Technical Report. 2018. Ethicon, Inc.

8. MacDonald M. Pivotal study comparing performance of SURGICEL. Powder—Absorbable Hemostatic Powder to ARISTA™ AH Absorbable Hemostatic Particles and PerClot. Polysaccharide Hemostatic System in a swine acute live biopsy model. Study 15-0120, Project 16438.

9. Expression testing- ADAPTIV Document 100293850-1. September 2, 2015. Ethicon, Inc.

10. Wang A. Surface energy/tension analysis among ORC Aggregate, ORC Fine Fiber, and Arista – Project PIXIE.

11. Cichocki FR, Maurer RE, Bar SN. Tungsten-rhenium suture needles with improved properties for coronary artery bypass graft surgery. J Biomed Mater Res B Appl Biomater. 2010;94B(2):493-500.

12. EVERPOINT Competitive Assessment, CT11-013. 2011. Ethicon, Inc.

13. de Jonge SW, Atema JJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical site infection. Brit J Surg. 2017;ePub-DOI: 10.1002/bjs.10445.

14. Su W. Study Report for in vitro evaluation of microbial barrier properties of Dermabond® Protape. 06TR071. December 4, 2006. Ethicon, Inc.

15. Bhende S. In-vitro study to evaluate the ability of DERMABOND™ PRINEO™ Skin Closure System to kill bacteria on contact. June 22, 2012. Ethicon, Inc.

 

VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION

INDICATION

VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.

CONTRAINDICATIONS

Do not inject directly into the circulatory system.

Do not use for the treatment of severe or brisk arterial bleeding.

Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.

Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.

WARNINGS AND PRECAUTIONS

Thromboembolic events may occur if VISTASEAL is administered intravascularly.

Only spray VISTASEAL if it is possible to accurately judge the distance from the spray tip to the tissue surface.

Hypersensitivity reactions can occur.

May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

ADVERSE REACTIONS

The most common adverse reactions (reported in >1% of clinical trial subjects) were nausea and procedural pain.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

115517-190529

 

SURGICEL® Powder Absorbable Hemostat Essential Product Information

INDICATIONS

SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® Powder can also be applied in laparoscopic or other endoscopic procedures when used with the SURGICEL™ Endoscopic Applicator.

The SURGICEL™ Endoscopic Applicator is intended for use in delivering SURGICEL® Powder absorbable hemostat to bleeding surgical sites through a 5 mm or larger trocar.

CONTRAINDICATIONS

• Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins.

• SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins.

• The SURGICEL® Powder and the SURGICEL™ Endoscopic Applicator devices were not designed for intraluminal procedures.

• When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.

• SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation.

WARNINGS

• SURGICEL® Powder is not intended for use on dry (non-bleeding) surfaces or for prevention of bleeding.

• Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided.

• SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances.

• SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. In preclinical in vivo animal studies it was demonstrated that SURGICEL® Powder does not increase the incidence of remote adhesions in laparoscopic procedures.

• Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.

• To prevent clogging with the SURGICEL™ Endoscopic Applicator Tip, do not touch the tip to wet surface. Be careful to avoid damaging tissue with the rigid tip.

• Do not attempt to trim the applicator tip. Replace the tip if it becomes clogged.

PRECAUTIONS

• SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems.

• Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.

• Use minimal amount of SURGICEL® Powder required to achieve hemostasis, and remove excess powder in the area of drains to prevent clogging. In urological procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

• Since absorption of SURGICEL® Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

• If SURGICEL® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped.

• Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis).

• The applicator tip provided on the SURGICEL® Powder device is not intended for laparoscopic or other endoscopic use. If laparoscopic or other endoscopic use is desired, remove the existing applicator tip from the SURGICEL® Powder device, and replace with the SURGICEL™ Endoscopic Applicator tip (supplied separately). In laparoscopic or other endoscopic procedures, SURGICEL® Powder should only be applied using the SURGICEL™ Endoscopic Applicator. Consult the SURGICEL™ Endoscopic Applicator Instructions for Use (IFU) for proper assembly and directions for use with the SURGICEL® Powder device.

• The SURGICEL Endoscopic Applicator is supplied with a flexible inner tip inside a rigid cannula. The rigid cannula cannot be used independently.

• The SURGICEL Endoscopic Applicator should only be used by persons having adequate training and familiarity with endoscopic techniques. Consult medical literature relative to techniques, complications, and hazards prior to performance of any endoscopic procedure.

• To prevent inadvertent device spillage, or unintended contact with tissue, organs, or blood, maintain visualization of the SURGICEL™ Endoscopic Applicator tip at all times.

• Do not compress or excessively bend the flexible inner tip of the SURGICEL Endoscopic Applicator which could obstruct the application of the powder. It is possible that the powder accumulated in the applicator could disperse beyond the target bleeding site upon compression of the bellows, which may require additional irrigation and aspiration.

ADVERSE EVENTS

• Paralysis and nerve damage have been reported when other SURGICEL® products were used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.

• Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS).

• Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.

• Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported.

• For more information and technical questions, call 1-800-795-0012. For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.

071582-190227

 

SURGICEL Essential Product Information

INDICATIONS

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL® NU-KNIT®, and SURGICEL® SNoW™ Absorbable Hemostats can be cut to size for use in endoscopic procedures.

PRECAUTIONS

Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction, such as encapsulation of the product, which may mimic artifacts on radiographic images, resulting in diagnostic errors and possible reoperation.

In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.)

Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions section of the complete product package insert).

ADVERSE EVENTS

“Encapsulation” of fluid and foreign body reactions have been reported.

There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.

Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.

Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was placed in the anterior cranial fossa.

Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.

For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012. For complete product information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product package inserts.


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